Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)2Cleared 510(K)
- K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)2Cleared 510(K)
- K241022Sterile single use tip cleaner (WK800-S10 , WK800-S20)2Cleared 510(K)
- K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6)2Cleared 510(K)
- K240070Profound Matrix2Cleared 510(K)
- K233123SILKRO2Cleared 510(K)
- K240017InMode System with the Morpheus8 90 Applicator2Cleared 510(K)
- K240657ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-2Cleared 510(K)
- K241055Electro Lube NXT2Cleared 510(K)
- K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter2Cleared 510(K)
- K233120CWM-930S, FIXER DV92Cleared 510(K)
- K233099Gladiator2Cleared 510(K)
- K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)2Cleared 510(K)
- K240999Legend X Applicator VO2Cleared 510(K)
- K240964FLOW 90? Wand2Cleared 510(K)
- K240248Volnewmer™2Cleared 510(K)
- K232805Kronos Electrocautery Device2Cleared 510(K)
- K234147ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)2Cleared 510(K)
- K233849BTL-4992Cleared 510(K)
- K222958mJOULE RF System and Accessories2Cleared 510(K)
- K233604BTL-785S2Cleared 510(K)
- K233642InMode RF System2Cleared 510(K)
- K233002BEED 2,5, BEED 3,82Cleared 510(K)
- K232301Define RF Microneedling System2Cleared 510(K)
- K233705CellFX Percutaneous Electrode System (SYS3000)2Cleared 510(K)
- K232703Disposable Bipolar Forceps2Cleared 510(K)
- K230837PlazMagik2Cleared 510(K)
- K233830OsteoCool™ 2.0 RF Ablation System2Cleared 510(K)
- K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)2Cleared 510(K)
- K240313Oligio X2Cleared 510(K)
- K231985Disposable Grounding Pad2Cleared 510(K)
- K232072AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G2Cleared 510(K)
- K234140VIVA combo RF System (VIVA combo RF System)2Cleared 510(K)
- K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)2Cleared 510(K)
- K231405Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode2Cleared 510(K)
- K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 12Cleared 510(K)
- K23299210THERMA2Cleared 510(K)
- K233374Secret Pro2Cleared 510(K)
- K232947SIRA™ RFA Electrosurgical Device2Cleared 510(K)
- K232290INTELLIO SHIFT System2Cleared 510(K)
- K231615Disposable Endoscopic Bipolar2Cleared 510(K)
- K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes2Cleared 510(K)
- K232033HYBRIDknife® flex2Cleared 510(K)
- K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)2Cleared 510(K)
- K233351Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force2Cleared 510(K)
- K233346Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);2Cleared 510(K)
- K231012CoolSeal Trinity2Cleared 510(K)
- K233147PiXel8-RF2Cleared 510(K)
- K231327POWERSEAL Sealer and Divider2Cleared 510(K)
- K222997VVR Generator system2Cleared 510(K)
- K233185MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System2Cleared 510(K)
- K232223PlaDuo System2Cleared 510(K)
- K231732CleanSeal Advanced Bipolar Vessel Sealer Maryland2Cleared 510(K)
- K231749Radio Frequency System2Cleared 510(K)
- K232903Legend X Platform2Cleared 510(K)
- K231495The Evolve System with the Transform Applicator2Cleared 510(K)
- K232809Cross Vascular RF Generator and Footswitch (optional accessory)2Cleared 510(K)
- K230650Monopolar Electrode Surgical Instrument2Cleared 510(K)
- K232460Disposable electrosurgical pencil (MD1000)2Cleared 510(K)
- K232407Cautery Protective Actuation System (CPAS)2Cleared 510(K)
- K232763Electrode Handpieces (VCT, RFTV, BMDT series)2Cleared 510(K)
- K230467BTL-899F2Cleared 510(K)
- K231146AliTight2Cleared 510(K)
- K221743Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes2Cleared 510(K)
- K223303Spinery™ RF Ablation System2Cleared 510(K)
- K231872Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)2Cleared 510(K)
- K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)2Cleared 510(K)
- K230663Density2Cleared 510(K)
- K223856NuEra Tight RF Family2Cleared 510(K)
- K231126Eblator Device2Cleared 510(K)
- K231790The InMode System with the Morpheus8 Applicators2Cleared 510(K)
- K230968VYBE RF Electrosurgical System2Cleared 510(K)
- K223135AblatePal Radiofrequency Ablation System2Cleared 510(K)
- K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)2Cleared 510(K)
- K231212da Vinci E-200 Electrosurgical Generator2Cleared 510(K)
- K223033Tixel® 2 System2Cleared 510(K)
- K230586Renuvion® Micro Handpiece2Cleared 510(K)
- K230498ArtiSential Laparoscopic Instruments-Electrodes2Cleared 510(K)
- K222556BTL-785X2Cleared 510(K)
- K230593Victan2Cleared 510(K)
- K230432Single Use Bipolar Forceps2Cleared 510(K)
- K223805Agnes2Cleared 510(K)
- K230547PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter2Cleared 510(K)
- K230539ArtiSential Laparoscopic Instruments-Electrodes2Cleared 510(K)
- K230272Renuvion® APR Handpiece2Cleared 510(K)
- K230499ArtiSential Laparoscopic Instruments-Electrodes2Cleared 510(K)
- K223932SafeAir combi (SFR-combi-US)2Cleared 510(K)
- K223784Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 100+, SEG 150+, SEG200, SEG200+2Cleared 510(K)
- K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)2Cleared 510(K)
- K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF20192Cleared 510(K)
- K223488ClosureFast™ Endovenous Radiofrequency Ablation Catheter2Cleared 510(K)
- K230194HF Surgery Generator 400KHZ2Cleared 510(K)
- K222709Retraction, CWM-910T, APOLEX Tite2Cleared 510(K)
- K220725HPR45i2Cleared 510(K)
- K223262Renuvion® APR Handpiece2Cleared 510(K)
- K220505ATTIVA2Cleared 510(K)
- K220996Duoblade2Cleared 510(K)
- K223158LigaSure™ XP Maryland Jaw Sealer/Divider2Cleared 510(K)
- K221522HF-cables (resusable)2Cleared 510(K)
- K223222Plasma IQ2Cleared 510(K)
- K221873NeoGen PSR System2Cleared 510(K)
- K223039da Vinci E-200 Electrosurgical Generator2Cleared 510(K)
- K223292TempSure System2Cleared 510(K)
- K221815Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)2Cleared 510(K)
- K213042Supra Non-Stick Bipolar Forceps2Cleared 510(K)
- K223110truSculpt iD2Cleared 510(K)
- K222032NEUROMARK System2Cleared 510(K)
- K222793WavelinQ™ Generator2Cleared 510(K)
- K221574LUDWIG Electrosurgical Device2Cleared 510(K)
- K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)2Cleared 510(K)
- K221989The Oligio2Cleared 510(K)
- K221830Apyx One Console2Cleared 510(K)
- K213610Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps2Cleared 510(K)
- K220138Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP2Cleared 510(K)
- K212561MTX-C12Cleared 510(K)
- K213674CellFX System2Cleared 510(K)
- K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device2Cleared 510(K)
- K222429Ellusa Reusable Bipolar Cable2Cleared 510(K)
- K222425Ellusa Reusable Neutral Plates2Cleared 510(K)
- K222075CellFX System2Cleared 510(K)
- K221277Mygen M-3004 RF Generator M-30042Cleared 510(K)
- K212222Soniquence Reusable 3 Button Fingerswitch Wand2Cleared 510(K)
- K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System2Cleared 510(K)
- K214058Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer2Cleared 510(K)
- K221671CellFX® System2Cleared 510(K)
- K221907RhinAer® Stylus (FG1393)2Cleared 510(K)
- K221945Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm2Cleared 510(K)
- K220970Renuvion APR Handpiece2Cleared 510(K)
- K203013AGNES2Cleared 510(K)
- K221407truSculpt iD2Cleared 510(K)
- K212472AgeJet2Cleared 510(K)
- K213786CiRX Single use electrosurgical pencil with non-coated and coated electrode2Cleared 510(K)
- K213612SYLFIRM X2Cleared 510(K)
- K211173maxmorespine Bipolar Electrodes2Cleared 510(K)
- K211000ACUTRON2Cleared 510(K)
- K210084SILKRO2Cleared 510(K)
- K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)2Cleared 510(K)
- K211652Renuvion Dermal Handpiece, Renuvion Dermal System2Cleared 510(K)
- K202106Plasmage System2Cleared 510(K)
- K210693PLEXR PLUS2Cleared 510(K)
- K212891TempSure System2Cleared 510(K)
- K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps2Cleared 510(K)
- K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart2Cleared 510(K)
- K211639BTL-785W2Cleared 510(K)
- K213127ReNew Disposable Scissor Tips2Cleared 510(K)
- K203150Cool-tip RF Ablation System E Series2Cleared 510(K)
- K220384ArtiSential Laparoscopic Instruments-Electrodes2Cleared 510(K)
- K220124YandR System, VoluDerm Handpiece, VoluDerm Tips2Cleared 510(K)
- K220071Soniquence Reusable Neutral Plate2Cleared 510(K)
- K213814Viveve 2.0 System2Cleared 510(K)
- K210727HotDog Warming Mattress + Return Electrode2Cleared 510(K)
- K213317ShinEvac Smoke Evacuation Pencil2Cleared 510(K)
- K213696ETHICON Megadyne Electrosurgical Generator2Cleared 510(K)
- K212093Medline Universal Grounding Pad2Cleared 510(K)
- K213344BTL-899A2Cleared 510(K)
- K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle2Cleared 510(K)
- K211172Single Use Electrosurgical Knife with Fluid Pump System2Cleared 510(K)
- K211217Profound Matrix2Cleared 510(K)
- K202818Voyant Fine Fusion Device (EB230)2Cleared 510(K)
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- K152031New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.2Cleared 510(K)
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- K151696Caiman Seal and Cut Technology2Cleared 510(K)
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- K012279PATTON TRIPOL2Cleared 510(K)
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- K021077MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD2Cleared 510(K)
- K021046COBRA COOLED SURGICAL PROBE, MODEL 1596X2Cleared 510(K)
- K020186CONMED SYSTEM 5000 ESU2Cleared 510(K)
- K020135CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-61202Cleared 510(K)
- K020832ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS2Cleared 510(K)
- K020047RUBICOR BREAST BIOPSY DEVICE2Cleared 510(K)
- K020067GYRUS ENT SOMNOPLASTY GENERATOR2Cleared 510(K)
- K013369RESECTION ABLATOR2Cleared 510(K)
- K020622ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS2Cleared 510(K)
- K014290ENTEC PLASMA WANDS2Cleared 510(K)
- K020031EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-3022Cleared 510(K)
- K014260TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE2Cleared 510(K)
- K014251NTERO HOTROD SYSTEM2Cleared 510(K)
- K020557ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS2Cleared 510(K)
- K014216SECCA SYSTEM2Cleared 510(K)
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- K014172NELSON ELECTROSURGICAL UNIT, MODEL GN6402Cleared 510(K)
- K013680CARBODISSECTING ENDOSCOPE2Cleared 510(K)
- K014201AARON REUSABLE ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K013904BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-2302Cleared 510(K)
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- K013668BERCHTOLD ELEKTROTOM 106 HITT2Cleared 510(K)
- K012314DYONICS ELECTROBLADE RESECTOR2Cleared 510(K)
- K013622NUCLEOTOMY INTRADISCAL CATHETER2Cleared 510(K)
- K013641SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS2Cleared 510(K)
- K013639THERMAGE THERMACOOL TC SYSTEM2Cleared 510(K)
- K014224PRECISION PLUS TUNA OFFICE SYSTEM2Cleared 510(K)
- K014222ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD2Cleared 510(K)
- K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY2Cleared 510(K)
- K013139STELLARTECH COAGULATION SYSTEM2Cleared 510(K)
- K012631REPROCESSED SOFT TISSUE ABLATORS2Cleared 510(K)
- K013463ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND2Cleared 510(K)
- K012725TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES2Cleared 510(K)
- K012679REPROCESSED RF ARTHROSCOPY PROBES2Cleared 510(K)
- K013255SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF2Cleared 510(K)
- K012700VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K012695VANGUARD REPROCESSED ARTHROSCOPIC WANDS2Cleared 510(K)
- K013348MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-1662Cleared 510(K)
- K012519ARTHROCARE ELECTROSURGERY WANDS2Cleared 510(K)
- K012625REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K012315LEVEEN ELECTRODE2Cleared 510(K)
- K013034MODIFICATION TO: THERMACOOL IIA2Cleared 510(K)
- K012986BIPOLAR IRRIGATION FORCEPS2Cleared 510(K)
- K012004EASY GUIDE ELECTROSURGICAL ACCESS DEVICE2Cleared 510(K)
- K012033MULTIFUNCTION ENDOSCOPIC INSTRUMENT2Cleared 510(K)
- K011929HANDPIECE SHEATH-MODEL #A9102Cleared 510(K)
- K012799ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL2Cleared 510(K)
- K012488MODIFICATION TO:ENDIUS BIPOLAR SHEATH2Cleared 510(K)
- K011722ATRICURE BIPOLAR COAGULATION SYSTEM2Cleared 510(K)
- K012129ORTHO DEVELOPMENT ORION-I EMF SYSTEM2Cleared 510(K)
- K011279ENTEC EVAC PLASMA WAND2Cleared 510(K)
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- K010815NTERO NOMAD SYSTEM2Cleared 510(K)
- K003190EN BLOC BIOPSY SYSTEM2Cleared 510(K)
- K001442ESU HANDSWITCHING PENCIL2Cleared 510(K)
- K010710SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES2Cleared 510(K)
- K010465DENSTAT2Cleared 510(K)
- K010661MODIFICATION TO TISSUELINK BIPOLAR FORCEPS2Cleared 510(K)
- K010487BIPOLAR PENCIL, MODEL 3901-002, 3900-0022Cleared 510(K)
- K010662MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL2Cleared 510(K)
- K010956COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X2Cleared 510(K)
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- K002000MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS;2Cleared 510(K)
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- K002981ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS1502Cleared 510(K)
- K010192ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION2Cleared 510(K)
- K010112BIPOLAR COAGULATION SYSTEM2Cleared 510(K)
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- K003897ENDIUS BIPOLAR SHEATH2Cleared 510(K)
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- K003005TISSUELINK BIPOLAR FORCEPS2Cleared 510(K)
- K002841COOL-TEC ELECTRODES2Cleared 510(K)
- K003587CLEARGLIDE PRECISION BIPOLAR DEVICE2Cleared 510(K)
- K002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE2Cleared 510(K)
- K003471MAGNA TEK ESU-4002Cleared 510(K)
- K002752BAYONET FORCEPS BIPOLAR IRRIGATING2Cleared 510(K)
- K002680TISSUELINK MONOPOLAR FLOATING BALL'2Cleared 510(K)
- K002582PILLING E-FRAZIER BIPOLAR SUCTION TUBE2Cleared 510(K)
- K003060PLASMAKINETIC GENERATOR2Cleared 510(K)
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- K001407SURGITRON IEC II2Cleared 510(K)
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- K001723COOL-TEC ELECTRODES2Cleared 510(K)
- K000944THERMAGE THERMACOOL SYSTEM2Cleared 510(K)
- K001904ARTHROCARE FLOW CONTROL UNIT2Cleared 510(K)
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- K001262THERMAL CAUTERY FORCEPS2Cleared 510(K)
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- K001438SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR2Cleared 510(K)
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- K994336BITX PROBES2Cleared 510(K)
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- K992045ELECTROSURGICAL ELECTRODE FAMILY2Cleared 510(K)
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- K993112XOMED ENT RF SYSTEM2Cleared 510(K)
- K992581ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS2Cleared 510(K)
- K993854ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES2Cleared 510(K)
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- K993647UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F2Cleared 510(K)
- K992542TUBULAR ELECTRODE DEVICE2Cleared 510(K)
- K992760SELECT-SUTTER MICRO BIPOLAR FORCEPS2Cleared 510(K)
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- K993055DEXIDE BIPOLAR FORCEPS II** DEVICE2Cleared 510(K)
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- K992460CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY2Cleared 510(K)
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- K992572NTERO RF SLEEVE2Cleared 510(K)
- K990362INSTRUMENT, ULTRASONIC, SCALPEL2Cleared 510(K)
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- K972267HELICA TC2Cleared 510(K)