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General, Plastic Surgery

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

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RecordFirmDate
DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL REPLACEMENT (P000036/S003)Shire Regenerative Medicine2003-12-15
RESTYLANE INJECTABLE GEL (P020023)Q-Med AB2003-12-12
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S010)Integra Lifesciences Corp.2003-12-04
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S007)Genzyme Corp.2003-12-04
DERMABOND TOPICAL SKIN ADHESIVE (P960052/S007)Closure Medical Corp.2003-12-01
SURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S019)ETHICON, Inc.2003-11-17
INDERMIL TISSUE ADHESIVE (P010002/S004)Covidien Lp, Formerly Registered AS United States2003-11-12
APLIGRAF (P950032/S036)Organogenesis, Inc.2003-10-24
SEPRAFLIM ADHESION BARRIER (P950034/S026)Baxter Healthcare Corporation2003-09-29
INSTAT ABSORBABLE COLLAGEN HEMOSTAT (P830079/S014)ETHICON, Inc.2003-09-26
APLIGRAF (P950032/S035)Organogenesis, Inc.2003-09-15
SURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S018)ETHICON, Inc.2003-08-20
MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES (P990075/S012)Mentor Worldwide, LLC2003-08-15
MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES (P990075/S013)Mentor Worldwide, LLC2003-08-14
WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER (P020021)Cook Endoscopy2003-08-01
DIOMED 630 PDT LASER (P990021/S001)Pinnacle Biologics, Inc.2003-08-01
OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES) (P940010/S010)Pinnacle Biologics, Inc.2003-08-01
MCGHAN SALINE-FILLED BREAST IMPLANTS (P990074/S015)Allergan2003-07-22
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB (P800002/S013)C.R. Bard, Inc.2003-07-11
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR AND AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S020)Davol Inc., Sub. C. R. Bard, Inc.2003-07-11
FLOSEAL NT HEMOSTATIC MATRIX (P990009/S014)Baxter Healthcare Corp2003-07-10
FLOSEAL MATRIX HEMOSTATIC SEALANT (P990009/S015)Baxter Healthcare Corp2003-07-03
DERMABOND TOPICAL SKIN ADHESIVE (P960052/S006)Closure Medical Corp.2003-06-13
SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK (P950034/S025)Baxter Healthcare Corporation2003-05-28
COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED) (P010022/S003)Angiotech Medical Device Technologies2003-05-06
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE AND FIBRILLAR FORM (P810006/S021)Integra LifeSciences Corporation2003-05-05
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE & FIBRILLAR FORM (P850010/S018)Integra LifeSciences Corporation2003-05-05
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S009)Integra Lifesciences Corp.2003-05-05
SEPRAFILM ADHESION BARRIER AND SEPRAFILM PROCEDURE PACK (P950034/S024)Baxter Healthcare Corporation2003-04-25
GELFOAM ABORBABLE GELATIN SPONGE (N18286/S014)Pfizer, Inc.2003-04-21
SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM (P010039/S002)Siemens Medical Solutions USA, Inc.2003-04-03
MENTOR SALINE-FILLED BREAST IMPLANT (P990075/S011)Mentor Worldwide, LLC2003-03-26
SEPRAFILM ADHESION BARRIER & SEPRAFILM PROCEDURE PACK (P950034/S023)Baxter Healthcare Corporation2003-03-25
COSEAL SURGICAL SEALANT (P010022/S002)Angiotech Medical Device Technologies2003-03-18
MCGHAN SALINE-FILLED BREAST IMPLANTS (P990074/S014)Allergan2003-03-12
COSMODERM 1 HUMAN-BASED COLLAGEN, COSMODERM 2 HUMAN-BASED COLLAGEN AND COSMOPLAST HUMAN-BASED COLLAGEN (P800022/S050)Allergan2003-03-11
MENTOR SALINE-FILLED BREAST IMPLANTS (P990075/S010)Mentor Worldwide, LLC2003-03-07
COSEAL SURGICAL SEALANT (PREMIXED) (P010022/S001)Angiotech Medical Device Technologies2003-02-04
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S006)Genzyme Corp.2003-02-04
INDERMIL TISSUE ADHESIVE (P010002/S003)Covidien Lp, Formerly Registered AS United States2003-01-31
BLU-U (P990019/S002)Sun Pharmaceutical Industries, Inc.2003-01-09
DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY (P960052/S004)Closure Medical Corp.2002-12-31
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S005)Genzyme Corp.2002-11-25
SEPRAFILM ADHESION BARRIER (P950034/S022)Baxter Healthcare Corporation2002-10-25
APLIGRAF (P950032/S034)Organogenesis, Inc.2002-10-15
SURGIFOAM ABSORBABLE GELATIN POWDER (P990004/S004)Ferrosan Meidcal Devices A/S2002-09-25
SALINE-FILLED BREAST IMPLANTS (P990074/S011)Allergan2002-09-04
SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS. (P990075/S009)Mentor Worldwide, LLC2002-09-03
SALINE-FILLED BREAST IMPLANTS (P990074/S013)Allergan2002-08-23
APLIGRAF (P950032/S033)Organogenesis, Inc.2002-08-12
MCGHAN SALINE-FILLED BREAST IMPLANT (P990074/S012)Allergan2002-08-08
DERMABOND TOPICAL SKIN ADHESIVE (P960052/S005)Closure Medical Corp.2002-07-24
APLIGRAF (P950032/S032)Organogenesis, Inc.2002-07-02
INDERMIL TISSUE ADHESIVE (P010002/S002)Covidien Lp, Formerly Registered AS United States2002-06-28
FLOSEAL MATRIX HEMOSTATIC SEALANT DEVICE (P990009/S012)Baxter Healthcare Corp2002-06-28
INDERMIL TISSUE ADHESIVE (P010002/S001)Covidien Lp, Formerly Registered AS United States2002-06-20
COSTASIS SURGICAL HEMOSTAT (P990030/S004)Angiotech Medical Device Technologies2002-06-13
MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES (P990075/S008)Mentor Worldwide, LLC2002-06-07
INDERMIL(TM) TISSUE ADHESIVE (P010002)Covidien Lp, Formerly Registered AS United States2002-05-22
MENTOR SPECTRUM SALINE-FILLED MAMARY PROSTHESES (P990075/S007)Mentor Worldwide, LLC2002-04-23
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S008)Integra Lifesciences Corp.2002-04-19
APLIGRAF (P950032/S031)Organogenesis, Inc.2002-04-09
HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S017)Integra LifeSciences Corporation2002-04-03
SEPRAFILM ADHESION BARRIER (P950034/S021)Baxter Healthcare Corporation2002-03-26
GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM (N18286/S013)Pfizer, Inc.2002-03-20
DERMAGRAFT (P000036/S002)Shire Regenerative Medicine2002-03-19
APLIGRAF (P950032/S029)Organogenesis, Inc.2002-03-14
COSTASIS/DYNASTAT SURGICAL HEMOSTATS (P990030/S003)Angiotech Medical Device Technologies2002-03-14
FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS (P990009/S010)Baxter Healthcare Corp2002-02-06
ORCEL BILAYERED CELLULAR MATRIX (P010016/S002)Forticell Bioscience2002-01-17
APILGRAF(GRAFTSKIN) (P950032/S028)Organogenesis, Inc.2002-01-17
TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S016)Shire Regenerative Medicine2001-12-26
COSTASIS/DYNASTAT SURGICAL HEMOSTAT (P990030/S002)Angiotech Medical Device Technologies2001-12-21
COSEAL SURGICAL SEALANT (COSEAL) (P010022)Angiotech Medical Device Technologies2001-12-14
MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS (P990074/S010)Allergan2001-12-12
AVITENE ULTRA WRAP COLLAGEN HEMOSTAT (N17600/S019)Davol Inc., Sub. C. R. Bard, Inc.2001-12-06
ORCEL BILAYERED CELLULAR MATRIX (P010016/S001)Forticell Bioscience2001-12-06
APLIGRAF(R)(GRAFTSKIN) (P950032/S019)Organogenesis, Inc.2001-11-19
DERMABOND(R) TOPICAL SKIN ADHESIVE (P960052/S003)Closure Medical Corp.2001-11-19
APLIGRAF (GRAFTSKIN) (P950032/S027)Organogenesis, Inc.2001-11-07
SALINE-FILLED BREAST IMPLANTS (P990074/S004)Allergan2001-11-07
APLIGRAF (GRAFTSKIN) (P950032/S020)Organogenesis, Inc.2001-11-07
FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS (P990009/S011)Baxter Healthcare Corp2001-10-31
MENTOR SALINE-FILLED MAMMARY PROSTHESES (P990075/S005)Mentor Worldwide, LLC2001-10-31
SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK (P950034/S018)Baxter Healthcare Corporation2001-10-04
SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S020)Baxter Healthcare Corporation2001-09-28
DERMAGRAFT (P000036)Shire Regenerative Medicine2001-09-28
VISULAS 690S AND VISULINK PDT/U ADAPTER (P990048/S001)Carl Zeiss Meditec, AG2001-09-27
COHERENT OPAL PHOTOACTIVATOR (P990049/S001)Lumenis2001-09-27
MCGHAN RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468 (P990074/S009)Allergan2001-09-21
APLIGRAF (GRAFTSKIN) (P950032/S026)Organogenesis, Inc.2001-09-14
SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY (P990075/S004)Mentor Worldwide, LLC2001-09-05
ORCEL BILAYERED CELLULAR MATRIX (P010016)Forticell Bioscience2001-08-31
TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE (P960007/S015)Shire Regenerative Medicine2001-08-30
FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM) (P990009/S009)Baxter Healthcare Corp2001-08-10
APLIGRAF (GRAFTSKIN) (P950032/S025)Organogenesis, Inc.2001-08-10
INTEGRA/DERMAL REGENERATION TEMPLATE (P900033/S006)Integra Lifesciences Corp.2001-08-10
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S007)Integra Lifesciences Corp.2001-08-10
MENTOR SALINE-FILLED BREAST IMPLANTS (P990075/S006)Mentor Worldwide, LLC2001-08-09
MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS (P990074/S008)Allergan2001-08-08
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