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
- ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent2Product Code
- EZXMesh, Surgical, Metal2Product Code
- MIBElastomer, Silicone Block2Product Code
- MICImplant, Muscle, Pectoralis2Product Code
- BTXBoard, Arm (With Cover), Sterile1Product Code
- FTLMesh, Surgical, Polymeric2Product Code
- K250869Parietene™ Macroporous Mesh (PPM5050 )2Cleared 510(K)
- K250098Bard Soft Mesh; Bard Soft Mesh Pre-Shaped2Cleared 510(K)
- K243315ProGrip™ Self-Gripping Polypropylene Mesh2Cleared 510(K)
- K2412503DMax Light Mesh2Cleared 510(K)
- K232373Progrip™ Self-Gripping Polypropylene Mesh2Cleared 510(K)
- K233402Bard 3DMax Mesh2Cleared 510(K)
- K232924T-Line® Hernia Mesh2Cleared 510(K)
- K230671Pitch PaSoft Tissue Reinforcement Device2Cleared 510(K)
- K230227T-Line Hernia Mesh2Cleared 510(K)
- K223218Parietene Macroporous Mesh2Cleared 510(K)
- K221556T-Line Hernia Mesh2Cleared 510(K)
- K220540ProGrip Self-Gripping Polypropylene Mesh2Cleared 510(K)
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device2Cleared 510(K)
- K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh2Cleared 510(K)
- K211132ARISTE AB Mesh2Cleared 510(K)
- K211563Pitch-Patchs2Cleared 510(K)
- K200918SurgiWrap FROST2Cleared 510(K)
- K201143VICRYL Mesh2Cleared 510(K)
- K2008183DMax MID Anatomical Mesh2Cleared 510(K)
- K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)2Cleared 510(K)
- K193144T-Line Hernia Mesh2Cleared 510(K)
- K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)2Cleared 510(K)
- K192443Dextile Anatomical Mesh2Cleared 510(K)
- K191373VICRYL Mesh2Cleared 510(K)
- K192112FlexBand Plus2Cleared 510(K)
- K191545Exogenesis Hernia Mesh2Cleared 510(K)
- K182008Phasix ST Mesh with Echo 2 Positioning System2Cleared 510(K)
- K181935Endoform Reconstructive Template - Non Absorbable2Cleared 510(K)
- K182087DynaMesh-POSTERIOR2Cleared 510(K)
- K181094Polydioxanone Surgical Scaffold2Cleared 510(K)
- K181268PROLENE (Polypropylene) 3D Patch2Cleared 510(K)
- K180910ULTRAPRO Mesh and ULTRAPRO ADVANCED2Cleared 510(K)
- K180829PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh2Cleared 510(K)
- K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)2Cleared 510(K)
- K172636VitaMESH Macroporous PP Surgical Mesh2Cleared 510(K)
- K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)2Cleared 510(K)
- K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)2Cleared 510(K)
- K172395Duatene bilayer mesh2Cleared 510(K)
- K172089PROLENE Soft Polypropylene Mesh2Cleared 510(K)
- K170134Reperen Surgical Mesh2Cleared 510(K)
- K163212Parietene DS Composite Mesh2Cleared 510(K)
- K163576GORE SYNECOR Preperitoneal Biomaterial2Cleared 510(K)
- K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval2Cleared 510(K)
- K163152PROLENE Soft Polypropylene Mesh2Cleared 510(K)
- K161550DynaMesh-VENTRAL2Cleared 510(K)
- K153632Endoform Reconstructive Template2Cleared 510(K)
- K153236Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay2Cleared 510(K)
- K152609GORE SYNECOR Biomaterial2Cleared 510(K)
- K152678TYRX Neuro Antibacterial Envelope2Cleared 510(K)
- K151386C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic2Cleared 510(K)
- K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH2Cleared 510(K)
- K151437ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug2Cleared 510(K)
- K150906ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh2Cleared 510(K)
- K150091Versatex Monofilament Mesh2Cleared 510(K)
- K142192Insightra Freedom Ventral Hernia Repair System2Cleared 510(K)
- K150291TYRX Neuro Absorbable Antibacterial Envelope2Cleared 510(K)
- K142706Modified ONFLEX Mesh2Cleared 510(K)
- K142711ONFLEX Mesh2Cleared 510(K)
- K143386Progrip Laparoscopic Self-Fixating Mesh2Cleared 510(K)
- K142611TYRX Neuro Absorbable Antibacterial Envelope2Cleared 510(K)
- K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh2Cleared 510(K)
- K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh2Cleared 510(K)
- K141560ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE2Cleared 510(K)
- K142091PARIETENE MACROPOROUS MESH2Cleared 510(K)
- K133889PREMIUM2Cleared 510(K)
- K141394X-REPAIR2Cleared 510(K)
- K141499X-REPAIRSL2Cleared 510(K)
- K140967FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK2Cleared 510(K)
- K133198ULTRAPRO COMFORT PLUG2Cleared 510(K)
- K140941PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH2Cleared 510(K)
- K132441BARD VENTRALEX HERNIA PATCH2Cleared 510(K)
- K132699AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)2Cleared 510(K)
- K130428COVAMESH2Cleared 510(K)
- K131530DYNAMESH -CICAT2Cleared 510(K)
- K131969SYMBOTEX(TM) COMPOSITE MESH2Cleared 510(K)
- K131007AIGIS RX N MEDIUM; AIGIS RX N LARGE2Cleared 510(K)
- K130943AIGIS RX R PM/ AIGIS RX R ICD2Cleared 510(K)
- K130968VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM2Cleared 510(K)
- K120844MEDLINX SURGICAL MESH2Cleared 510(K)
- K123479PROGRIP LAPAROSCOPIC SELF-FIXATING MESH2Cleared 510(K)
- K122436COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM2Cleared 510(K)
- K113552FREEDOM INGUINAL HERNIA IMPLANT2Cleared 510(K)
- K113229VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING2Cleared 510(K)
- K113311TIO2MESH TM2Cleared 510(K)
- K120897PROGRIP LAPARSCOPIC SELF-FIXATING MESH2Cleared 510(K)
- K120025SURGIMESH XB - SKIRTED2Cleared 510(K)
- K120506PARIETEX COMPOSITE VENTRAL PATCH2Cleared 510(K)
- K121070C-QUR RPM MESH2Cleared 510(K)
- K111695HYBRID GRAFT2Cleared 510(K)
- K111337TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD2Cleared 510(K)
- K112567BIOMERIX ASSURE2Cleared 510(K)
- K112499BIOMERIX COMPOSITE SURGICAL MESH2Cleared 510(K)
- K112784RENASYS AB ABOMINAL DRESSING KIT2Cleared 510(K)
- K110663PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)2Cleared 510(K)
- K100313HYDROFIX SURGICAL SHEET2Cleared 510(K)
- K111121VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH2Cleared 510(K)
- K102788TORNIER BIOFIBER SCAFFOLD2Cleared 510(K)
- K110816PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)2Cleared 510(K)
- K110815PARIETEX OPTIMIZED COMPOSTIE MESH2Cleared 510(K)
- K110820VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM2Cleared 510(K)
- K101928VENTRALEX ST HERNIA PATCH2Cleared 510(K)
- K101920VENTRIO ST HERNIA PATCH2Cleared 510(K)
- K103682PARIETEX PROGRIP2Cleared 510(K)
- K103445ALACER SURGICAL SCAFFOLD2Cleared 510(K)
- K110110ATRIUM CENTRILFX MESH2Cleared 510(K)
- K103568RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH2Cleared 510(K)
- K102766COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM2Cleared 510(K)
- K101519PARIETEX PLUG AND PATCH2Cleared 510(K)
- K100787RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT2Cleared 510(K)
- K101462ASCEND BLUE AC MESH; ASCEND BLUE PC MESH2Cleared 510(K)
- K101851VENTRALIGHT ST MESH2Cleared 510(K)
- K093196BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC092Cleared 510(K)
- K092233SURGIMESH XD2Cleared 510(K)
- K093123BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB2Cleared 510(K)
- K101197PARIE TENE PROGRIP MESH2Cleared 510(K)
- K093799TORNIER SURGICAL MESH2Cleared 510(K)
- K100229VENTRIO HERNIA PATCH2Cleared 510(K)
- K093932ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH2Cleared 510(K)
- K093524PIVIT A/B ST AND PIVIT A/B ST-R2Cleared 510(K)
- K092538REFINE SUPPORT SYSTEM, MODEL 100.01002Cleared 510(K)
- K100076ATRIUM C-QUR OVT MESH2Cleared 510(K)
- K092224TIGR SURGICAL MESH , MODEL WK-62Cleared 510(K)
- K090271HYDROCOAT MESH2Cleared 510(K)
- K092032BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 01171602Cleared 510(K)
- K093166WITTMANN PATCH2Cleared 510(K)
- K091659BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 0117322Cleared 510(K)
- K090909C-QUR V -PATCH MESH2Cleared 510(K)
- K090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM2Cleared 510(K)
- K090489ABTHERA OPEN ABDOMEN DRESSING, MODEL: M82750262Cleared 510(K)
- K083102REFINE LIFT SYSTEM2Cleared 510(K)
- K090858PARIETEX MONOFILAMENT POLYESTER MESH2Cleared 510(K)
- K090288ORTHADAPT PR2Cleared 510(K)
- K083467REBOUND HRDV2Cleared 510(K)
- K083307SYNTHASOME X-REPAIR2Cleared 510(K)
- K083266GORE BIO-A FISTULA PLUG2Cleared 510(K)
- K081377NUVASIVE SURGICAL MESH SYSTEM2Cleared 510(K)
- K082748ATRIUM PROLITE S MESH2Cleared 510(K)
- K082941BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-12152Cleared 510(K)
- K080442SERISCAFFOLD SURGICAL MESH2Cleared 510(K)
- K081010BARD 3DMAX MESH2Cleared 510(K)
- K081777VENTRIO HERNIA PATCH2Cleared 510(K)
- K080216SUPRAMESH EXTRA2Cleared 510(K)
- K082216TBD ETHICON MESH2Cleared 510(K)
- K073579DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN2Cleared 510(K)
- K072974SURGIMESH XB2Cleared 510(K)
- K081126PARIETEX COMPOSITE MONO PM MESH2Cleared 510(K)
- K072370SURGICRAFT SURGICAL MESH SYSTEM2Cleared 510(K)
- K072962CABS'AIR2Cleared 510(K)
- K081327RELIMESH2Cleared 510(K)
- K081069GORE INFINIT MESH2Cleared 510(K)
- K081050PARIETEX PROGRIP MESH2Cleared 510(K)
- K080836MODIFICATION TO ENDOFAST RELIANT SYSTEM2Cleared 510(K)
- K080688C-QUR LITE MESH V-PATCH2Cleared 510(K)
- K080691C-QUR EDGE MESH V-PATCH2Cleared 510(K)
- K080353LTM-T SURGICAL MESH2Cleared 510(K)
- K080393MODIFICATION TO REBOUND HRD2Cleared 510(K)
- K073287PREVADH MESH2Cleared 510(K)
- K073164IVS TUNNELLER DEVICES2Cleared 510(K)
- K070961BIOMERIX SURGICAL MESH, MODEL: RCR-012Cleared 510(K)
- K072190ORTHO-WRAP BIORESORBABLE SHEET2Cleared 510(K)
- K063091PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-06012Cleared 510(K)
- K071695KENSEY NASH MACROPORE SHIELD2Cleared 510(K)
- K072520TEPHAFLEX SURGICAL FILM2Cleared 510(K)
- K071887SPORTMESH OR ARTELON TISSUE REINFORCEMENT2Cleared 510(K)
- K071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX2Cleared 510(K)
- K0709184DDOME2Cleared 510(K)
- K063671REBOUND HRD2Cleared 510(K)
- K070625PELVIMESH / HERMESH 72Cleared 510(K)
- K061934XTAC2Cleared 510(K)
- K071629PARIETEX POLYESTER MESH WITH INTRODUCER2Cleared 510(K)
- K063154FACIAL RECONSTRUCTIVE MESH (FRM)2Cleared 510(K)
- K070846MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM2Cleared 510(K)
- K071249ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV2Cleared 510(K)
- K070993TOPAS SYSTEM2Cleared 510(K)
- K070018UNIVERSAL SURGICAL MESH, MODEL 1002Cleared 510(K)
- K070224ULTRAPRO PLUG2Cleared 510(K)
- K070644GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS2Cleared 510(K)
- K070192ATRIUM PROLITE ULTRA S MESH2Cleared 510(K)
- K063648SURGI-WRAP MAST TENDON SHEET2Cleared 510(K)
- K061445SURGIMESH WN2Cleared 510(K)
- K063739SEPRAMESH, MODEL 5959-12142Cleared 510(K)
- K061533PROCEED VENTRAL PATCH2Cleared 510(K)
- K063435GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL2Cleared 510(K)
- K061754BARD COMPOSITE L/P MESH2Cleared 510(K)
- K062697SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT2Cleared 510(K)
- K061473SURGI-WRAP MAST BIORESORBABLE SHEET2Cleared 510(K)
- K060329ENDOFAST RELIANT SYSTEM2Cleared 510(K)
- K060018TRULENE MESH2Cleared 510(K)
- K061704OPTILENE MESH2Cleared 510(K)
- K053215SURGICAL MESH SYSTEM2Cleared 510(K)
- K053656TYRX ANTIMICROBIAL MESH2Cleared 510(K)
- K061314BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH2Cleared 510(K)
- K060713PROCEED SURGICAL MESH2Cleared 510(K)
- K050311ATRIUM MEDICAL CORPORATION C-QUR MESH2Cleared 510(K)
- K060520VITAMESH MACROPOROUS PP SURGICAL MESH2Cleared 510(K)
- K060004CALDERA MESH2Cleared 510(K)
- K053424POPMESH2Cleared 510(K)
- K052830SPORTMESH2Cleared 510(K)
- K053158OPTILENE MESH LP2Cleared 510(K)
- K052864TYRX SURGICAL MESH, MODEL SMPC-05012Cleared 510(K)
- K053066SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH2Cleared 510(K)
- K053200GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL2Cleared 510(K)
- K053202GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL2Cleared 510(K)
- K052155BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED2Cleared 510(K)
- K051701VICRYL * MESH BAG2Cleared 510(K)
- K050969INCLOSE SURGICAL MESH SYSTEM2Cleared 510(K)
- K052100MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH2Cleared 510(K)
- K051766ORTHOMEND2Cleared 510(K)
- K050332SURGI-WRAP MAST BIORESORBABLE SHEET2Cleared 510(K)
- K050678MOTIFMESH SOFT TISSUE PATCH2Cleared 510(K)
- K050418TISSUE FIXATION SYSTEM2Cleared 510(K)
- K043191REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH2Cleared 510(K)
- K050187PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES2Cleared 510(K)
- K043081GORE POLYPROPYLENE HERNIA MESH2Cleared 510(K)
- K043056GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL2Cleared 510(K)
- K043366PERMACOL SURGICAL IMPLANT2Cleared 510(K)
- K042811VIVOSORB SHEET, MODEL FS012Cleared 510(K)
- K042026BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 01180042Cleared 510(K)
- K040998MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH2Cleared 510(K)
- K033337ULTRAPRO MESH2Cleared 510(K)
- K033814BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 01170072Cleared 510(K)
- K033376UGYTEX MESH2Cleared 510(K)
- K032893SHELHIGH NO-REACT BIOCUFF2Cleared 510(K)
- P990028FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT2PMA Approval
- K032865GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL2Cleared 510(K)
- K032673IMMIX PLASTIFILM2Cleared 510(K)
- K031225TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 60000042Cleared 510(K)
- K031955MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET2Cleared 510(K)
- K031925PROCEED TRILAMINATE SURGICAL MESH2Cleared 510(K)
- K032168GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL2Cleared 510(K)
- K031188ORTHOMEND2Cleared 510(K)
- K030631ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH2Cleared 510(K)
- K024199IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP2Cleared 510(K)
- K022011V.A.C. ABDOMINAL DRESSING2Cleared 510(K)
- K024008SMALL BARD VENTRALEX PATCH2Cleared 510(K)
- P990028FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT2PMA Approval
- K023328REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH2Cleared 510(K)
- P990028FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT2PMA Approval
- K021835BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX2Cleared 510(K)
- K022782DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL2Cleared 510(K)
- K022350BARD CRURASOFT PATCH, MODELS 0116003 & 01160012Cleared 510(K)
- K021736BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 00103012Cleared 510(K)
- K014183AFB (ABSORBABLE FOAM BUTTRESS)2Cleared 510(K)
- K012025MACROPORE SURGIWRAP (TS)2Cleared 510(K)
- P990028FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT2PMA Approval
- K010533BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH2Cleared 510(K)
- K010722PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH2Cleared 510(K)
- P990028FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT2PMA Approval
- K010035IVS TUNNELLER2Cleared 510(K)
- K010228GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES2Cleared 510(K)
- K002699PARIETEX COMPOSITE (PCO) MESH2Cleared 510(K)
- K003917MODIFICATION TO FLUOROTEX II SURGICAL MESH2Cleared 510(K)
- K003906MODIFICATION TO FLUROTEX SURGICAL MESH2Cleared 510(K)
- K003990SOFRADIM PARIETEX SURGICAL MESHES2Cleared 510(K)
- K003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,00102052Cleared 510(K)
- K002721AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH2Cleared 510(K)
- K002672VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH2Cleared 510(K)
- K002479BIOMESH P1 AND BIOMESH PLUG AND PATCH2Cleared 510(K)
- K002684COMPOSIX E/X MESH2Cleared 510(K)
- K002351FLUOROTEX II SURGICAL MESH2Cleared 510(K)
- K002093ATRIUM LITE MESH2Cleared 510(K)
- K002071SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES2Cleared 510(K)
- K001122PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH2Cleared 510(K)
- K000849SOFTFORM FACIAL IMPLANT2Cleared 510(K)
- K994328SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX2Cleared 510(K)
- K992556PERMACOL2Cleared 510(K)
- K000185GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)2Cleared 510(K)
- K992991ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT2Cleared 510(K)
- K983753STAR TEMPORARY WOUND COVER2Cleared 510(K)
- K992189GORE-TEX DUALMESH BIOMATERIAL2Cleared 510(K)
- K991400PARIETENE POLYPROPYLENE MESH2Cleared 510(K)
- K991637BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 01147002Cleared 510(K)
- K9909303D ANATOMICAL MESH2Cleared 510(K)
- K984220MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH2Cleared 510(K)
- K982532PARIETEX2Cleared 510(K)
- K984197FLUOROTEX SURGICAL MESH2Cleared 510(K)
- K982575MESH, SURGICAL, POLYMERIC2Cleared 510(K)
- K982475SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL2Cleared 510(K)
- K981756SHELHIGH NO-REACT PNEUMOPLEDGETS2Cleared 510(K)
- K974540SIS HERNIA REPAIR DEVICE2Cleared 510(K)
- K973955HERNIAMESH SURGICAL MESHES2Cleared 510(K)
- K980483MENTOR SUSPEND SLING2Cleared 510(K)
- K981051SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES2Cleared 510(K)
- K973462SOFTFORM FACIAL IMPLANT2Cleared 510(K)
- K973082VENTRAL WALL DEFECT REDUCTION SILO2Cleared 510(K)
- K972412PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH2Cleared 510(K)
- K971745BARD COMPOSITE PROSTHESIS2Cleared 510(K)
- K970561GRAFT PATCH2Cleared 510(K)
- K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA2Cleared 510(K)
- K964857RAPISEAL PATCH2Cleared 510(K)
- K965038GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE2Cleared 510(K)
- K964761S.A.M. FACIAL IMPLANT W/INTRODUCER2Cleared 510(K)
- K963226SURGICAL FABRICS2Cleared 510(K)
- K963619GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES2Cleared 510(K)
- K963141KUGEL HERNIA PATCH2Cleared 510(K)
- K962971POLYPROPYLENE MESH (VARIOUS SIZES)2Cleared 510(K)
- K962496SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)2Cleared 510(K)
- K962401GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES2Cleared 510(K)
- K962530PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH2Cleared 510(K)
- K961440SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH2Cleared 510(K)
- K960481SOFT TISSUE AUGMENTATION TUBE2Cleared 510(K)
- K960219PROLEX MESH2Cleared 510(K)
- K954665GLYCAR STAPLE STRIPS2Cleared 510(K)
- K955494GORE-TEX DUALMESH BIOMATERIAL WITH HOLES2Cleared 510(K)
- K952898GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER2Cleared 510(K)
- K951700GORE-TEX SOFT TISSUE PATCH2Cleared 510(K)
- K951675GORE-TEX MYCROMESH BIOMATERIAL2Cleared 510(K)
- K951676GORE-TEX DUALMESH BIOMATERIAL2Cleared 510(K)
- K953577BARD VISILEX MESH 3 X 62Cleared 510(K)
- K946107GORE-TEX MYCROMESH PLUS BIOMATERIAL2Cleared 510(K)
- K946106GORE-TEX DUALMESH PLUS BIOMATERIAL2Cleared 510(K)
- K945060HERNIA MESH INTRODUCTION SYSTEM2Cleared 510(K)
- K945899GORE-TEX(R) CURVED SURGICALMEMBRANE2Cleared 510(K)
- K942911GLYCAR TISSUE REPAIR PATCH2Cleared 510(K)
- K945377TRELEX NATURAL(R) MESH2Cleared 510(K)
- K944413ACM PTFE SURGICAL MESH2Cleared 510(K)
- K922452GORE-TEX SOFT TISSUE PATCH PLUS2Cleared 510(K)
- K941299FLARED PATCH2Cleared 510(K)
- K942583PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT2Cleared 510(K)
- K933827BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS2Cleared 510(K)
- K930822GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH2Cleared 510(K)
- K931936GIANTURCO-HELFRICH HERNIS MESH2Cleared 510(K)
- K930669ATRIUM POLYPROPYLENE MESH2Cleared 510(K)
- K926478GORE-TEK(R) SOFT TISSUE PATCH2Cleared 510(K)
- K931150GORE-TEX MICRO MESH2Cleared 510(K)
- K926565GORE-TEX(TM) DUAL MESH2Cleared 510(K)
- K925148AUTO SUTURE SURGICAL MESH DEPLOYER2Cleared 510(K)
- K924749TRELEX MESH2Cleared 510(K)
- K922916BARD MARLEX MESH DART2Cleared 510(K)
- K915526COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH2Cleared 510(K)
- K914449GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE2Cleared 510(K)
- K905655NONABSORBABLE POLYPROPYLENE SURGICAL MESH2Cleared 510(K)
- K840172VENTRAL WALL DEFECT REDUCT SILO2Cleared 510(K)
- K833764STERILIZATION OF GORE-TEX SOFT TISSU2Cleared 510(K)
- K820193GORE-TEX TISSUE REINFORCEMENT PATCH2Cleared 510(K)
- K810428VICRYL2Cleared 510(K)
- K792281USHER'S MARLEX TUBULAR MESH2Cleared 510(K)
- FTMMesh, Surgical2Product Code
- FTNPlastic Surgery And Accessories Kit1Product Code
- FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3Product Code
- FWMProsthesis, Breast, Inflatable, Internal, Saline3Product Code
- FWPProsthesis, Chin, Internal2Product Code
- FYIAppliance, Facial Fracture, External1Product Code
- FZDProsthesis, Ear, Internal2Product Code
- FZEProsthesis, Nose, Internal2Product Code
- FZFSplint, Extremity, Inflatable, External1Product Code
- GBIMaterial, External Aesthetic Restoration, Used With Adhesive1Product Code
- GBJProsthesis, Adhesive, External1Product Code
- JCQProsthesis, Esophagus2Product Code
- KCZProsthesis, Breast, External, Used With Adhesive1Product Code
- KDAProsthesis, Ptfe/Carbon-Fiber2Product Code
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2Product Code
- LZKImplant, Malar2Product Code
- MCATape, Surgical, Internal2Product Code
- MNFImplant, Temporal2Product Code
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile1Product Code
- NODBoard, Arm (With Cover), Non-Sterile1Product Code
- NOJProsthesis, Breast, External, No Adhesive1Product Code
- NOKMaterial, External Aesthetic Restoration, No Adhesive1Product Code
- NWAProsthesis, Tracheal, Preformed/Molded2Product Code
- NYTProsthesis, Tracheal, Expandable, Polymeric2Product Code
- ODUFacial Implant2Product Code
- OXGMesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery2Product Code
- OODSurgical Film2Product Code
- OQLMesh, Surgical, Deployment Balloon2Product Code
- ORQMesh, Surgical, Deployer2Product Code
- OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery2Product Code
- OWSMesh, Surgical, Collagen, Plastics, Facial Implants2Product Code
- OWTMesh, Surgical, Absorbable, Abdominal Hernia2Product Code
- OWUMesh, Surgical, Non-Absorbable, Diaphragmatic Hernia2Product Code
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia2Product Code
- OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction2Product Code
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement2Product Code
- OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement2Product Code
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement2Product Code
- OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery2Product Code
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery2Product Code
- OXIMesh, Surgical, Absorbable, Large Abdominal Wall Defects2Product Code
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects2Product Code
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects2Product Code
- OXLMesh, Surgical, Absorbable, Organ Support2Product Code
- OXMMesh, Surgical, Absorbable, Fistula2Product Code
- OXNMesh, Surgical, Collagen, Fistula2Product Code
- PIJCollagen Surgical Mesh Containing Drugs2Product Code
- PQNCarbon Dioxide Gas Controlled Tissue Expander2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- GENZYME CORP.
- Trade Name
- FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT
- Generic Name
- Sealant, polymerizing
- Decision Date
- 5/26/2000
- Days to Decision
- 354 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval