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General, Plastic Surgery

3,113 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
DERMAGRAFT-TC(TM) (P960007/S005)Shire Regenerative Medicine1998-02-12
OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010/S002)Pinnacle Biologics, Inc.1998-01-09
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011/S001)Lumenis, Inc.1998-01-09
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S001)American Medical Systems, Inc.1998-01-09
DERMAGRAFT-TC(TM) (P960007/S003)Shire Regenerative Medicine1997-11-24
DERMAGRAFT-TC(TM) (P960007/S001)Shire Regenerative Medicine1997-10-17
SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S007)Baxter Healthcare Corporation1997-09-11
INTEGRA (ARTIFICIAL SKIN) (P900033/S002)Integra Lifesciences Corp.1997-08-07
SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S006)Baxter Healthcare Corporation1997-06-30
PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S027)ETHICON, Inc.1997-05-12
OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010/S003)Pinnacle Biologics, Inc.1997-04-04
TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007)Shire Regenerative Medicine1997-03-18
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S002)Baxter Healthcare Corporation1996-12-17
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S003)Baxter Healthcare Corporation1996-12-16
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008)Davis & Geck, Inc.1996-11-15
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S001)Baxter Healthcare Corporation1996-11-07
GORE-TEX(TM) SUTURE (P820083/S024)W. L. Gore & Associates, Inc.1996-10-03
GORE-TEX(TM) SUTURE (P820083/S023)W. L. Gore & Associates, Inc.1996-10-03
GORE-TEX(R) SUTURE (P820083/S021)W. L. Gore & Associates, Inc.1996-09-24
GORE-TEX SUTURE WITH PLEDGETS (P820083/S022)W. L. Gore & Associates, Inc.1996-09-24
INTEGRA (ARTIFICIAL SKIN) (P900033/S001)Integra Lifesciences Corp.1996-09-23
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034)Baxter Healthcare Corporation1996-08-12
OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010/S001)Pinnacle Biologics, Inc.1996-08-07
SURGICEL FIBRILLAR ABSORBABLE HEMOSTATT (N12159/S016)ETHICON, Inc.1996-05-15
INTEGRA DERMAL REGENERATION TEMPLATE (P900033)Integra Lifesciences Corp.1996-03-01
SURGICEL* FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S015)ETHICON, Inc.1996-02-01
ZYDERM I AND II AND ZYPLAST COLLAGEN IMPLANTS (P800022/S048)Allergan1996-02-01
SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT (N12159/S013)ETHICON, Inc.1996-01-16
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007)Davis & Geck, Inc.1996-01-11
NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006)Davis & Geck, Inc.1996-01-11
OPTIGUIDE(TM) FIBER OPTIC DIFFUSER (P940010)Pinnacle Biologics, Inc.1995-12-27
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011)Lumenis, Inc.1995-12-27
600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012)American Medical Systems, Inc.1995-12-27
AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S013)Davol Inc., Sub. C. R. Bard, Inc.1995-12-27
ZYPLAST COLLAGEN IMPLANT ZYDERM I AND II COLLAGEN IMPLANT (P800022/S049)Allergan1995-11-30
ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P930030/S001)Coletica S.A.1995-11-30
PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S025)ETHICON, Inc.1995-11-02
AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S014)Davol Inc., Sub. C. R. Bard, Inc.1995-09-14
COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE (P810006/S019)Integra LifeSciences Corporation1995-09-12
HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S015)Integra LifeSciences Corporation1995-09-12
PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S026)ETHICON, Inc.1995-09-07
HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE (P930030)Coletica S.A.1995-08-15
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
INSTAT COLLAGEN ABSORBABLE HEMOSTAT (P830079/S011)ETHICON, Inc.1995-07-07
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S023)Allergan1995-06-16
GORE-TEX(R) SUTURE (P820083/S020)W. L. Gore & Associates, Inc.1995-06-05
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S046)Allergan1995-05-24
GELFOAM (N18286/S008)Pfizer, Inc.1995-05-16
SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT (N12159/S014)ETHICON, Inc.1995-05-12
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S047)Allergan1995-04-26
SUPERSTAT (P810040/S007)Superstat Corp.1995-04-21
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S035)Allergan1995-04-17
ALVEOFORM TM BIOGRAFT (P860012/S005)Collagen Corp.1995-03-21
GORE-TEX(R) SUTURE (P820083/S019)W. L. Gore & Associates, Inc.1995-01-23
AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S012)Davol Inc., Sub. C. R. Bard, Inc.1995-01-20
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014)Datascope Corp.1994-12-22
PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S024)ETHICON, Inc.1994-12-21
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S045)Allergan1994-11-14
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) (P800002/S010)C.R. Bard, Inc.1994-09-09
GORE-TEX(R) SUTURE (P820083/S017)W. L. Gore & Associates, Inc.1994-08-19
MICROFIBRILLAR COLLAGEN HEMOSTAT (N17600/S010)Davol Inc., Sub. C. R. Bard, Inc.1994-08-12
GORE-TEX(R) SUTURE (P820083/S018)W. L. Gore & Associates, Inc.1994-08-11
NOVAFIL(TM) (P840041/S005)Davis & Geck, Inc.1994-04-20
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S015)W. L. Gore & Associates, Inc.1994-04-08
GORE-TEX(R) SUTURE (P820083/S016)W. L. Gore & Associates, Inc.1994-01-10
COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE (P810006/S018)Integra LifeSciences Corporation1993-12-21
PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S023)ETHICON, Inc.1993-12-09
COLLASTAT HEMO SPONGE CHANGE IN PACKAGING (P810006/S016)Integra LifeSciences Corporation1993-11-01
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S041)Allergan1993-11-01
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S040)Allergan1993-11-01
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S044)Allergan1993-11-01
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S014)W. L. Gore & Associates, Inc.1993-10-15
SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT (N12159/S012)ETHICON, Inc.1993-10-13
ZYPLAST(R) AND ZYDERM(R)COL.IMP./QUAL.CON.CHANGE (P800022/S039)Allergan1993-09-30
AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S011)Davol Inc., Sub. C. R. Bard, Inc.1993-09-29
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S013)W. L. Gore & Associates, Inc.1993-07-01
ACCESS MOBILITY SYSTEM (P900050/S001)Quest Technologies Corp.1993-06-14
HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S014)Integra LifeSciences Corporation1993-06-08
COLLASTAT MICROFIBRILLAR HEMOSTATIC AGENT (P810006/S017)Integra LifeSciences Corporation1993-05-13
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S042)Allergan1993-05-13
ZYPLAST(R) AND ZYDERM(R)COL.IMPLANT/DEAERATING (P800022/S038)Allergan1993-04-12
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) (P800002/S009)C.R. Bard, Inc.1993-04-09
HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010)Datascope Corp.1992-11-16
GELFOAM (N18286/S007)Pfizer, Inc.1992-09-10
ZYPLAST(R) AND ZYDERM(R)COLLAGEN IMPLANT (P800022/S036)Allergan1992-09-02
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013)Datascope Corp.1992-08-26
ZYPLAST(R) COLLAGEN IMPLANT (3.0 CC SYRINGE) (P800022/S033)Allergan1992-07-27
GELFOAM (N18286/S006)Pfizer, Inc.1992-07-21
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S032)Allergan1992-07-07
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S034)Allergan1992-07-07
GELFOAM (N18286/S005)Pfizer, Inc.1992-04-30
HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S013)Integra LifeSciences Corporation1992-03-27
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006)Davis & Geck, Inc.1992-03-24
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S028)Allergan1992-01-08
MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S008)C.R. Bard, Inc.1992-01-07
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S027)Allergan1991-12-16
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S029)Allergan1991-12-16
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S030)Allergan1991-12-06
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005)Davis & Geck, Inc.1991-10-17
HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011)Datascope Corp.1991-10-04
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