Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- EZTPacemaker, Bladder3Product Code
- EZWStimulator, Electrical, Implantable, For Incontinence3Product Code
- EZYDevice, Incontinence, Mechanical/Hydraulic3Product Code
- FAHDilator, Urethral, Mechanical2Product Code
- BSSTube, Nasogastric2Product Code
- EXASelector, Size, Ostomy1Product Code
- EXBCollector, Ostomy1Product Code
- EXDIrrigator, Ostomy2Product Code
- EXEProtector, Ostomy1Product Code
- EXFBag, Bile Collecting2Product Code
- EXGBag, Urine Collecting, Ureterostomy1Product Code
- EXHBag, Urinary, Ileostomy1Product Code
- EXIDevice, Paste-On For Incontinence, Sterile1Product Code
- EXJDevice, Incontinence, Urosheath Type, Sterile1Product Code
- EXNSupport, Hernia1Product Code
- EYAStylet, Ureteral1Product Code
- EYBCatheter, Ureteral, Gastro-Urology2Product Code
- EYCCatheter, Upper Urinary Tract2Product Code
- EYIAdaptor, Ureteral Catheter1Product Code
- EYJHolder, Ureteral Catheter1Product Code
- EYKConnector, Ureteral Catheter1Product Code
- EYQGarment, Protective, For Incontinence1Product Code
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile1Product Code
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile1Product Code
- EZBStylet For Catheter, Gastro-Urology1Product Code
- EZCCatheter, Coude2Product Code
- EZDCatheter, Straight2Product Code
- EZKCatheter, Retention Type2Product Code
- EZLCatheter, Retention Type, Balloon2Product Code
- EZMDilator, Esophageal (Metal Olive) Gastro-Urology2Product Code
- EZNDilator, Catheter, Ureteral2Product Code
- EZQPouch, Colostomy1Product Code
- EZRCement, Stomal Appliance, Ostomy1Product Code
- EZSAppliance, Colostomy, Disposable1Product Code
- FAQBag, Urine Collection, Leg, For External Use, Sterile1Product Code
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology2Product Code
- FAXBougie, Urological1Product Code
- FBMCannula And Trocar, Suprapubic, Non-Disposable1Product Code
- FBRUrethrometer1Product Code
- FBWFiliform And Filiform Follower1Product Code
- FBXSound, Urethral, Metal Or Plastic1Product Code
- FCBBag, Hemostatic2Product Code
- FCEEnema Kit1Product Code
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)2Product Code
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter2Product Code
- FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression2Product Code
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation2Product Code
- FEWCatheter, Malecot2Product Code
- FEXInstrument, Catheter, Punch1Product Code
- FEZCatheter And Tube, Suprapubic2Product Code
- FFATube, Drainage, Suprapubic2Product Code
- FFHCollector, Urine, Pediatric, For Indwelling Catheter2Product Code
- FFPDilator, Rectal1Product Code
- FFWString And Tubes, Gastrointestinal, To Locate Internal Bleeding2Product Code
- FGDCatheter, Retention, Barium Enema With Bag2Product Code
- FGEStents, Drains And Dilators For The Biliary Ducts2Product Code
- FGFCatheter, Ureteral Disposable (X-Ray)2Product Code
- FGHCatheter, Double Lumen Female Urethrographic2Product Code
- FGICatheter, Urethrographic, Male2Product Code
- FHAClamp, Penile1Product Code
- FHSDialyzer, Single Coil2Product Code
- FHTSet, Gavage, Infant, Sterile2Product Code
- FIAChair, Dialysis, Unpowered, Without Scales1Product Code
- FIBProtector, Transducer, Dialysis2Product Code
- FIDTubing, Dialysate2Product Code
- FIENeedle, Fistula2Product Code
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump2Product Code
- FIGClamp, Tubing, Blood, Automatic2Product Code
- FIHPump, Infusion Or Syringe, Extra-Luminal2Product Code
- FIISystem, Dialysate Delivery, Sealed2Product Code
- FIJSystem, Dialysate Delivery, Recirculating, Single Pass2Product Code
- FIKSystem, Dialysate Delivery, Recirculating2Product Code
- FILSystem, Dialysate Delivery, Single Pass2Product Code
- FINTank, Holding, Dialysis2Product Code
- FIPSubsystem, Water Purification2Product Code
- FIQCannula, A-V Shunt2Product Code
- FIRPump, Blood, Extra-Luminal2Product Code
- FISFlowmeter, Dialysate2Product Code
- FIWAlarm, Pillow Pressure2Product Code
- FIZMeter, Conductivity, Non-Remote2Product Code
- FJAManometer, Water2Product Code
- FJBDetector, Dialysate Level2Product Code
- FJCDetector, Blood Level2Product Code
- FJDDetector, Leak, Blood2Product Code
- FJFDetector, Air Bubble2Product Code
- FJGDialyzer, Parallel Flow2Product Code
- FJHDialyzer, Disposable2Product Code
- FJIDialyzer, Capillary, Hollow Fiber2Product Code
- FJJDialyzer, Twin Coil2Product Code
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2Product Code
- FJMGuard, Shunt2Product Code
- FJNStabilizer, Shunt2Product Code
- FJOPlier, Tube1Product Code
- FJPAdaptor, Y2Product Code
- FJQConnector, Shunt1Product Code
- FJRForceps, Disconnect1Product Code
- FJSCatheter, Peritoneal, Long-Term Indwelling2Product Code
- FJTIntracatheter, Dialysis2Product Code
- FJWRing, Joint1Product Code
- FJXRing, Crimp1Product Code
- FJYPlier, Crimp1Product Code
- FJZDeclotting Tray, Kit (Including Contents)2Product Code
- FKADilator, Vessel2Product Code
- FKBConnector, Blood Tubing, Infusion T2Product Code
- FKCClamp, Cannula1Product Code
- FKDCanister, Coil2Product Code
- FKETie, Dialysis1Product Code
- FKFGun, Tie, Dialysis1Product Code
- FKGTray, Start/Stop (Including Contents), Dialysis1Product Code
- FKHSolution-Test Standard-Conductivity, Dialysis2Product Code
- FKISet, Dialyzer Holder2Product Code
- FKJFilter, Blood, Dialysis2Product Code
- FKLInsert, Pump, Blood2Product Code
- FKMAdaptor, Fistula2Product Code
- FKNAdaptor, Shunt2Product Code
- FKOCatheter, Peritoneal Dialysis, Single Use2Product Code
- FKPSystem, Dialysate Delivery, Single Patient2Product Code
- FKQSystem, Dialysate Delivery, Central Multiple Patient2Product Code
- FKRSubsystem, Proportioning2Product Code
- FKTSystem, Dialysate Delivery, Sorbent Regenerated2Product Code
- FKWTip, Vessel2Product Code
- FKXSystem, Peritoneal, Automatic Delivery2Product Code
- FKYConnector, Tubing, Dialysate2Product Code
- FLAMonitor, Temperature, Dialysis2Product Code
- FLBMeter, Conductivity, Induction, Remote Type2Product Code
- FLCStation, Dialysis Control, Negative Pressure Type2Product Code
- FLDApparatus, Hemoperfusion, Sorbent2Product Code
- FOCBag, Urine Collection, Newborn2Product Code
- FONBag, Drainage, With Adhesive, Ostomy1Product Code
- FPDTube, Feeding2Product Code
- FRQTube, Levine2Product Code
- GBLCatheter, Ureteral, General & Plastic Surgery2Product Code
- GBMCatheter, Urethral2Product Code
- GBTCatheter, Rectal2Product Code
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection2Product Code
- GDSBag, Stomal1Product Code
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration2Product Code
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2Product Code
- KDJSet, Administration, For Peritoneal Dialysis, Disposable2Product Code
- K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch2Cleared 510(K)
- K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C44832Cleared 510(K)
- K21401615L Cycler Drainage Bag2Cleared 510(K)
- K192705MiniCap Extended Life PD Transfer Sets2Cleared 510(K)
- K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch2Cleared 510(K)
- K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set2Cleared 510(K)
- K173363Cycler Drain Bag Set2Cleared 510(K)
- K151620Firefly Peritoneal Dialysis Connector Disinfection System2Cleared 510(K)
- K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER2Cleared 510(K)
- K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution2Cleared 510(K)
- K124024APD LUER-LOCK ADAPTER2Cleared 510(K)
- K083542FRESENIUS STERILE STAY SAFE CAP2Cleared 510(K)
- K042900K.E.P. CONNECTOR AND CLIP2Cleared 510(K)
- K041792FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-872112Cleared 510(K)
- K031676HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q2Cleared 510(K)
- K022412FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR2Cleared 510(K)
- K974387PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE2Cleared 510(K)
- K972579HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE2Cleared 510(K)
- K972731NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET2Cleared 510(K)
- K963668MEDISYSTEMS PERITONEAL DIALYSIS SETS2Cleared 510(K)
- K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C44932Cleared 510(K)
- K945567QC CAP2Cleared 510(K)
- K930843RAPID DISCONNECT Y-SET, CAT. NO. 48-70002Cleared 510(K)
- K921818ABBOTT SMART CAP2Cleared 510(K)
- K925403BAXTER APD 12' EXTENSION LINE2Cleared 510(K)
- K921052FRESENIUS VARIABLE FILL MONITOR2Cleared 510(K)
- K920586DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET2Cleared 510(K)
- K920029DEXTROLYTE II CAPD TRNSFER SET2Cleared 510(K)
- K915628DEXTROLYTE II PERITONEAL DIALYSIS PUMP2Cleared 510(K)
- K915304ABBOTT SMART CAP2Cleared 510(K)
- K912208FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE2Cleared 510(K)
- K904806CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR2Cleared 510(K)
- K900295PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES2Cleared 510(K)
- K90386990/2 PERITONEAL DIALYSIS SYSTEM DISPOS CYCLER SET2Cleared 510(K)
- K902526CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C44812Cleared 510(K)
- K902451LONG-LIFE Y-SET CAT. NO. 48-6366-82Cleared 510(K)
- K900106CLOSED DISCONNECT SYSTEM2Cleared 510(K)
- K895992CATHETER EXTENSION SET CAT. NO. 48-3027-92Cleared 510(K)
- K895792DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-62Cleared 510(K)
- K900323PERITONEAL DIALYSIS CYCLER SET2Cleared 510(K)
- K900226DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-62Cleared 510(K)
- K900243DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-62Cleared 510(K)
- K900242DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-32Cleared 510(K)
- K900141DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-62Cleared 510(K)
- K900140DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/32Cleared 510(K)
- K900142DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-22Cleared 510(K)
- K900008DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET2Cleared 510(K)
- K900012DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET2Cleared 510(K)
- K896600DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-12Cleared 510(K)
- K896599DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)2Cleared 510(K)
- K895991PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-62Cleared 510(K)
- K895990DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET2Cleared 510(K)
- K900005DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-12Cleared 510(K)
- K900004CONVERTIBLE ADAPTER CATALOG NO. 48-4039-32Cleared 510(K)
- K900006CATHETER ADAPTER SEALING CAP NO. 48-1028-92Cleared 510(K)
- K896956QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-32Cleared 510(K)
- K896764UNIVERSAL CONNECTOR CATALOG NO. 48-1025-52Cleared 510(K)
- K896761TRANSFER SET SEALING CAP, CAT. NO. 48-1027-12Cleared 510(K)
- K896763CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-12Cleared 510(K)
- K895673CONNECTION SHIELDS CODES 5C4213 AND 5C42152Cleared 510(K)
- K895631DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C44662Cleared 510(K)
- K894783PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP2Cleared 510(K)
- K893712PERITONEAL DIALYSIS SYSTEM AND ACCESS.2Cleared 510(K)
- K893231DELCLAMP2Cleared 510(K)
- K892870PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD2Cleared 510(K)
- K892872PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD2Cleared 510(K)
- K892871PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD2Cleared 510(K)
- K883393CAPD DISPOSABLE Y SYSTEM - DY SET2Cleared 510(K)
- K883239CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS2Cleared 510(K)
- K882498EXTENDED LIFE CAPD TRANSFER SET 5C44442Cleared 510(K)
- K882455EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC43732Cleared 510(K)
- K873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)2Cleared 510(K)
- K871155DELFLEX RIGID DRAIN CONTAINER2Cleared 510(K)
- K871583MODIFIED LABELING FOR AMUKIN-50%2Cleared 510(K)
- K870626FREEDOM SET II WITH TRIFLEX VALVE2Cleared 510(K)
- K871154DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE2Cleared 510(K)
- K871050CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.2Cleared 510(K)
- K871049CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.2Cleared 510(K)
- K870145EXTERNAL Y VALVE 5C41982Cleared 510(K)
- K860700CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C41862Cleared 510(K)
- K860230CAPD TRANSFER SET SPIKE 5C43632Cleared 510(K)
- K853550TRAVENOL CAPD Y SET 5C43542Cleared 510(K)
- K852678CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C43532Cleared 510(K)
- K851208COMPACT EXCHANGE DEVICE 5C41972Cleared 510(K)
- K851207EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C41532Cleared 510(K)
- K820546CARD U.V. GERMICIDAL CHAMBER II2Cleared 510(K)
- K812802CAPD U.V. GERMICIDAL CONNECTION SYSTEM2Cleared 510(K)
- K813069PERITONEAL DIALYSIS CYCLER SET2Cleared 510(K)
- K812772PERITONEAL DIALYSIS CYCLER SET (8UNIT)2Cleared 510(K)
- K812771PERITONEAL DIALYSIS DRAINAGE2Cleared 510(K)
- K811863STERI-TRACT2Cleared 510(K)
- K812130SPIKE GUARD2Cleared 510(K)
- K811294GAMBRO PERITONEAL DIALYSIS FLUID LINES2Cleared 510(K)
- K810840AMP PERITONEAL DIALYSIS PREP KIT2Cleared 510(K)
- K810671CCPD 3 LITER DRAINAGE SET2Cleared 510(K)
- K810670CCPD CYCLER SET2Cleared 510(K)
- K810600CAPD EXCHANGE SET2Cleared 510(K)
- K803300INPERSOL CAPD BAG PORT CLAMP2Cleared 510(K)
- K801881INPERSOL-CAPD ADMINISTRATION SET2Cleared 510(K)
- K801220PERITONEAL DIALYSIS CYCLER SET W/PUMP2Cleared 510(K)
- K801193CLIRANS TE15 HOLLOW FIBER DIALYZER2Cleared 510(K)
- K800993INPERSOL CAPD ADMIN. SET & CATHETER ADAP2Cleared 510(K)
- K792651CAPD TRANSFER SET JC90442Cleared 510(K)
- K791512CONTINUOUS AMBULATORY DIALYSIS (CAPD)2Cleared 510(K)
- K791722DISPOSABLE PERITONEAL DIALYSIS EXTENSION2Cleared 510(K)
- K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C41452Cleared 510(K)
- K791426PERITONEAL PAC2Cleared 510(K)
- K781755DAP-PAK2Cleared 510(K)
- K780957SET, ADMINISTRATION, MANUAL, DIALYSIS2Cleared 510(K)
- K780082PERITONEAL DIALYSIS ADMIN. SET2Cleared 510(K)
- K772236FILTER, PERITONEAL DIALY. ADMIN. SET2Cleared 510(K)
- K771482RINSE BLOCK CONNECTOR2Cleared 510(K)
- K772136PERITONEAL CYCLER & MANIFOLD SET2Cleared 510(K)
- KDKContainer, Transport, Kidney2Product Code
- KDLSet, Perfusion, Kidney, Disposable2Product Code
- KDNSystem, Perfusion, Kidney2Product Code
- KGCTube, Gastro-Enterostomy2Product Code
- KNQDilator, Esophageal2Product Code
- KNRAdapter, A-V Shunt Or Fistula2Product Code
- KNTTubes, Gastrointestinal (And Accessories)2Product Code
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter2Product Code
- KNYAccessories, Catheter, G-U2Product Code
- KNZAccessories, A-V Shunt2Product Code
- KOBCatheter, Suprapubic (And Accessories)2Product Code
- KOCAccessories, Blood Circuit, Hemodialysis2Product Code
- KODCatheter, Urological2Product Code
- KOEDilator, Urethral2Product Code
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal2Product Code
- KPHCatheter, Rectal For Continent Ileostomy1Product Code
- KPIStimulator, Electrical, Non-Implantable, For Incontinence2Product Code
- KPLColonic Irrigation System2Product Code
- KPMShunt, Peritoneal2Product Code
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2Product Code
- KPPPeritoneal Dialysate Filter2Product Code
- KQQTubing, Dialysate (And Connector)2Product Code
- KQRDetector, Air Or Foam2Product Code
- KXMSystem Accessories, Extracorporeal2Product Code
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)2Product Code
- LCGIntestinal Splinting Tubes2Product Code
- LFJCatheter, Subclavian2Product Code
- LFKCatheter, Femoral2Product Code
- LIFDialyzer Reprocessing System2Product Code
- LJHSystem, Irrigation, Urological2Product Code
- LKYDevice, External Penile Rigidity2Product Code
- LLBSystem, Blood, Extracorporeal And Accessories2Product Code
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological2Product Code
- LQRDislodger, Stone, Biliary2Product Code
- LRIPh Meter For Dialysis Hydrogen Ion Concentration2Product Code
- MJCCatheter, Urological (Antimicrobial) And Accessories2Product Code
- MLWWarmer, Peritoneal Dialysate2Product Code
- MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female1Product Code
- MNVStrip, Dialysate Ph Indicator2Product Code
- MONSystem, Hemodialysis, Remote Accessories1Product Code
- MPBCatheter, Hemodialysis, Non-Implanted2Product Code
- MQSSystem, Hemodialysis, Access Recirculation Monitoring2Product Code
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation2Product Code
- MSDCatheter, Hemodialysis, Implanted2Product Code
- MSEHemodialyzer, Re-Use, Low Flux2Product Code
- MSFHemodialyzer, Re-Use, High Flux2Product Code
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant2Product Code
- MSZStrip, Test, Reagent, Residuals For Dialysate2Product Code
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction2Product Code
- NDSMedia, Culture, Ex Vivo, Tissue And Cell2Product Code
- NFKKit, Repair, Catheter, Hemodialysis2Product Code
- NHVSystem, Water Purification, General Medical Use2Product Code
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted2Product Code
- NIFCatheter, Hemodialysis, Triple Lumen, Implanted2Product Code
- NMLCatheter, Biliary, Reprocessed2Product Code
- NNENeedle, Fistula, Reprocessed2Product Code
- NNGSet, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed2Product Code
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile1Product Code
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile1Product Code
- NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NOADevice, Paste-On For Incontinence, Non-Sterile1Product Code
- NOOClamp, Dialysis Arm1Product Code
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia2Product Code
- NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use2Product Code
- NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator2Product Code
- NUBColonic Irrigation System, General Well Being3Product Code
- NYUCatheter, Hemodialysis, Implanted, Coated2Product Code
- NWOKit, Catheter, Urinary (Exludes Hiv Testing)2Product Code
- NWPSuprapubic Cystostomy Catheter Kit2Product Code
- NWQKit, Catheter, External, Male (Excludes Hiv Testing)2Product Code
- NWRKit, Catheter, Foley (Excludes Hiv Testing)2Product Code
- NZUCollector, Urine, Powered, Non Indwelling Catheter1Product Code
- ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System2Product Code
- ODXAutonomous Extracorporeal Blood Leak Detector/Alarm2Product Code
- OHRCatheter Care Tray2Product Code
- ONWHemodialysis System For Home Use2Product Code
- ONYOral Removable Retainer For Weight Management2Product Code
- PBPRectal Insert2Product Code
- PCUPancreatic Stent, Covered, Metallic, Removable2Product Code
- PEHHemodialysis Catheter Luer End Cap2Product Code
- PEVDialysis Administration Kit2Product Code
- PEWImplantable Transprostatic Tissue Retractor System2Product Code
- PFHVenous Window Needle Guide2Product Code
- PIAVibrator For Climax Control Of Premature Ejaculation2Product Code
- PIDEsophageal Dilator Balloon With Or Without Electrode Sensors2Product Code
- PIEEsophageal Dilator With Balloon And Electrode Sensors2Product Code
- PIFGastrointestinal Tubes With Enteral Specific Connectors2Product Code
- QGCSuprapubic Catheter Accessories1Product Code
- PIHUrethral Insert With Pump For Bladder Drainage2Product Code
- PINKidney Perfusion Kit2Product Code
- PIOEnteral Specific Transition Connectors2Product Code
- PJHDynamic Rectal Control System2Product Code
- PKIFully Subcutaneous Implanted Hemodialysis Catheter2Product Code
- PLIGastrointestional Tube Holder2Product Code
- PLQEnzyme Packed Cartridge2Product Code
- PNBBiliary Stent System For Benign Strictures2Product Code
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling2Product Code
- PNREnteral Syringes With Enteral Specific Connectors2Product Code
- QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss2Product Code
- PPABladder Irrigation Kit2Product Code
- PPBFoley Catheter Kit (Excludes Hiv Testing)2Product Code
- PPCMale External Catheterization Kit (Excludes Hiv Testing)2Product Code
- PPDUniversal Drainage Tray2Product Code
- PPFUrinary Irrigation Kit2Product Code
- PPGUrinary Drainage Collection Kit2Product Code
- PPHSingle Needle With Uni-Directional Pump Kit2Product Code
- PPIHemodialysis Tray (Not A Start/Stop Kit)2Product Code
- PPJPeritoneal Dialysis Administration Kit2Product Code
- PPKPeritoneal Dialysis Tubing Kit2Product Code
- PPLSingle Needle (Co-Axial Flow) Dialysis Kit2Product Code
- PPOMulti-Lumen Hemodialysis Catheterization Kit2Product Code
- PQEOstomy Care Kit1Product Code
- PRMEnteral Administration Kit (Adult & Pediatric)2Product Code
- PROAnti-Regurgitation Blood Tubing Kit2Product Code
- PRPBalloon Gastrostomy Tube Kit2Product Code
- PRQEsophageal Dilator Kit2Product Code
- PRRFeeding Tube Kit2Product Code
- PRSGastric Colonic Catheter Irrigation Kit2Product Code
- PRTGastric Irrigation And Aspiration Kit2Product Code
- PRWGastrointestinal Tube Kit2Product Code
- PRXGastrostomy Guide Wire Placement Kit2Product Code
- PRYGastrostomy Jejunostomy Feeding Tube Kit2Product Code
- PRZGastrostomy Tube Kit2Product Code
- PSALaparoscopic Jejunostomy Kit2Product Code
- PSBNasogastric Feed Tube Kit2Product Code
- PSCNasogastric-Gastrojejunal Kit2Product Code
- PSDLaparoscopic Gastrostomy Kit2Product Code
- PSENeedle Catheter Jejunostomy Kit2Product Code
- PSFNon-Balloon Replacement Gastrostomy System2Product Code
- PSGPercutaneous Endoscopic Gastrostomy Kit2Product Code
- PSHPercutaneous Replacement Gastrostomy Tube Kit2Product Code
- PSJRectal Dilator Kit1Product Code
- PSKReplacement Gastrostomy Feeding Catheter Tray2Product Code
- PSXChlorine Meter2Product Code
- PTKPediatric Esophageal Atresia Anastomosis Device3Product Code
- PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt2Product Code
- PTUCatheter, Peritoneal, Long-Term Indwelling, Exempt2Product Code
- PTVCatheter, Peritoneal Dialysis, Single Use, Exempt2Product Code
- PTWSystem, Peritoneal, Automatic Delivery, Exempt2Product Code
- QAJCutaneous Electrode Stimulator For Urinary Incontinence2Product Code
- QAXHemodialyzer With Expanded Solute Removal Profile2Product Code
- QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories1Product Code
- QGEBiliary Stent, Drain, And Dilator Accessories1Product Code
- QIRPediatric Hemodialysis System2Product Code
- QJNLaparoscopic Accessories, Esophageal Sizing2Product Code
- QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia2Product Code
- QMYComputerized Behavioral Therapy Device For Treating Symptoms2Product Code
- QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence3Product Code
- QRCNon-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation2Product Code
- SCTFoley Catheters And Accessories With Additional Safety Features2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
QC CAP
- Page Type
- Cleared 510(K)
- 510(k) Number
- K945567
- 510(k) Type
- Traditional
- Applicant
- MEDIONICS INTERNATIONAL, INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/7/1995
- Days to Decision
- 133 days
- Submission Type
- Statement