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General, Plastic Surgery

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

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RecordFirmDate
EXABLATE 2000/2100 (P110039/S004)Insightec2013-12-17
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S048)Integra LifeSciences Corporation2013-12-16
RADIESSE (P050052/S047)Merz North America, Inc.2013-12-11
RADIESSE (P050037/S044)Merz North America, Inc.2013-12-11
JUVEDERM VOLUMA XC (P110033/S001)Allergan2013-12-06
HELISTAT,HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S033)Integra LifeSciences Corporation2013-11-29
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S027)Integra Lifesciences Corp.2013-11-29
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S036)Integra LifeSciences Corporation2013-11-29
RADIESSE DERMAL FILLER (P050052/S046)Merz North America, Inc.2013-11-27
RADIESSE DERMAL FILLER (P050037/S043)Merz North America, Inc.2013-11-27
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S031)Allergan2013-11-26
ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES (P100030/S001)Baxter Healthcare Corporation2013-11-25
VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S025)Stryker Corp.2013-11-15
ARTERX SURGICAL SEALANT, (P100030/S002)Baxter Healthcare Corporation2013-11-05
RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS (P040024/S071)Q-Med AB2013-10-25
RADIESSE (P050052/S044)Merz North America, Inc.2013-10-24
RADIESSE (P050037/S041)Merz North America, Inc.2013-10-24
JUVEDERM VOLUMA XC (P110033)Allergan2013-10-22
VITAGEL SURGICAL HEMOSTAT (P050044/S021)Stryker Corp.2013-10-11
SALINE-FILLED & SPECTRUM BREAST IMPLANTS (P990075/S022)Mentor Worldwide, LLC2013-10-08
FLOSEAL HEMOSTATIC MATRIX (P990009/S035)Baxter Healthcare Corp2013-09-19
RADIESSE (P050037/S039)Merz North America, Inc.2013-09-17
RADIESSE (P050052/S042)Merz North America, Inc.2013-09-17
RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FO (P050052/S043)Merz North America, Inc.2013-09-16
RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORARION AND OR/ CORRECTION OF THE SIGNS OF FACIAL FAT LO (P050037/S040)Merz North America, Inc.2013-09-16
SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S032)ETHICON, Inc.2013-09-12
NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S023)Allergan2013-09-10
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S032)Allergan2013-09-06
INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S031)Integra Lifesciences Corp.2013-08-29
COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT, MICROFIBRILLAR FORM (P810006/S044)Integra LifeSciences Corporation2013-08-29
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S042)Integra LifeSciences Corporation2013-08-29
BELLAFILL (P020012/S008)Tiger Aesthetics Medical, LLC2013-08-27
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S043)Integra LifeSciences Corporation2013-08-23
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S045)Integra LifeSciences Corporation2013-08-23
MENTOR SPECTRUM BREAST IMPLANTS (P990075/S024)Mentor Worldwide, LLC2013-08-20
SCULPTRA AND SCULPTRA AESTHETIC (P030050/S018)Q-Med AB2013-08-16
SCULPTRA AESTHETIC (P030050/S015)Q-Med AB2013-08-15
APLIGRAF (P950032/S074)Organogenesis, Inc.2013-08-13
EXABLATE (P110039/S003)Insightec2013-08-06
ARISTA AH (P050038/S017)Davol, Inc.2013-08-02
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT (P800002/S019)C.R. Bard, Inc.2013-07-24
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT (N17600/S028)Davol Inc., Sub. C. R. Bard, Inc.2013-07-24
RADIESSE DERMAL FILLER (P050037/S038)Merz North America, Inc.2013-07-16
RADIESSE DERMAL FILLER (P050052/S041)Merz North America, Inc.2013-07-16
BELOTERO BALANCE DERMAL FILLER (P090016/S007)Merz North America, Inc.2013-07-16
APLIGRAF (P950032/S072)Organogenesis, Inc.2013-07-11
NATRELLE SILICONE FILLED BREAST IMPLANTS (P020056/S022)Allergan2013-07-10
NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS (P040046/S004)Allergan2013-07-10
NATRELLE SALINE FILLED BREAST IMPLANT (P990074/S027)Allergan2013-07-10
AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE (N17600/S027)Davol Inc., Sub. C. R. Bard, Inc.2013-06-27
HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S041)Integra LifeSciences Corporation2013-06-26
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S030)Integra Lifesciences Corp.2013-06-26
COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR FORM (P810006/S043)Integra LifeSciences Corporation2013-06-26
APLIGRAF (P950032/S073)Organogenesis, Inc.2013-06-25
NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S021)Allergan2013-06-20
NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S003)Allergan2013-06-20
HELISTAT AND HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S039)Integra LifeSciences Corporation2013-06-20
COLLASTAT/INSTAT MCH ABSORBABLE COLLAGEN HEMOSTATIC AGENT-FIBRILLAR FORM (P810006/S042)Integra LifeSciences Corporation2013-06-20
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S040)Integra LifeSciences Corporation2013-06-20
FLOSEAL HEMOSTATIC MATRIX (P990009/S036)Baxter Healthcare Corp2013-06-19
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S040)Integra LifeSciences Corporation2013-06-19
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P810006/S041)Integra LifeSciences Corporation2013-06-19
ARISTA AH ABSORBABLE HEMOSTAT (P050038/S018)Davol, Inc.2013-06-18
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT FIBULLAR FORM (P850010/S036)Integra LifeSciences Corporation2013-06-18
HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S038)Integra LifeSciences Corporation2013-06-18
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S037)Integra LifeSciences Corporation2013-06-18
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT (P810006/S039)Integra LifeSciences Corporation2013-06-18
MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028)Mentor Worldwide, LLC2013-06-14
NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S020)Allergan2013-06-12
NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S002)Allergan2013-06-12
NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S026)Allergan2013-06-12
INTEGRA ARTIFICIAL SKIN REGENERATION TEMPLATE (P900033/S029)Integra Lifesciences Corp.2013-06-10
HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S035)Integra LifeSciences Corporation2013-06-10
COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S038)Integra LifeSciences Corporation2013-06-10
GELFOAM (ABSORBABLE GELATIN) POWDER,USP (N18286/S025)Pfizer, Inc.2013-06-03
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S028)Integra Lifesciences Corp.2013-06-03
COLLASTAT ABSORBABLE COLLEGEN HEMOSTATIC SPONGE (P810006/S037)Integra LifeSciences Corporation2013-06-03
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S034)Integra LifeSciences Corporation2013-06-03
RADIESSSE (P050052/S040)Merz North America, Inc.2013-05-30
RADIESSE (P050037/S037)Merz North America, Inc.2013-05-30
SCULPTRA AESTHETIC (P030050/S014)Q-Med AB2013-05-28
DERMAGRAFT (HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE) (P000036/S017)Shire Regenerative Medicine2013-05-23
DERMAGRAFT (HUMAN FIBROBLAST -DERIVED DERMAL SUBSTITUTE) (P000036/S018)Shire Regenerative Medicine2013-05-21
DERMAGRAFT (P000036/S016)Shire Regenerative Medicine2013-05-21
MENTOR SALINE-FILLED BREAST IMPLANTS (P990075/S023)Mentor Worldwide, LLC2013-05-15
RADIESSE INJECTABLE IMPLANT (P050052/S039)Merz North America, Inc.2013-04-23
SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S031)ETHICON, Inc.2013-04-23
RADIESSE INJECTABLE IMPLANT (P050037/S036)Merz North America, Inc.2013-04-23
ARISTA AH ABSORABLE HEMOSTAT (P050038/S016)Davol, Inc.2013-04-05
MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S012)Mentor Corp.2013-04-05
SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE (P020056/S019)Allergan2013-03-27
SALINE FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE (P990074/S025)Allergan2013-03-27
NATRELLE SILICONE -FILLED BREAST IMPLANTS (P040046/S001)Allergan2013-03-27
ARISTA AH ABSORBABLE HEMOSTAT PARTICLES (P050038/S015)Davol, Inc.2013-03-21
BELOTERO BALANCE, BELOTERO BALANCE (SAMPLE) (P090016/S006)Merz North America, Inc.2013-03-21
INSIGHTEC EXABLATE SYSTEM (P110039/S002)Insightec2013-03-15
INSIGHTEC EXABLATE SYSTEM (P110039/S001)Insightec2013-03-15
APLIGRAF (P950032/S071)Organogenesis, Inc.2013-03-14
JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC (P050047/S030)Allergan2013-03-11
BELOTERO BALANCE (P090016/S004)Merz North America, Inc.2013-03-08
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