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General, Plastic Surgery

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

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RecordFirmDate
ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/FLEXITIP XL-R (P050038/S028)Davol, Inc.2016-01-07
SEPRAFILM ADHESION BARRIER (P950034/S044)Baxter Healthcare Corporation2016-01-07
INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO (P900033/S042)Integra Lifesciences Corp.2016-01-07
SPECTRUM BREAST IMPLANTS (P990075/S035)Mentor Worldwide, LLC2016-01-07
RADIESSE INJECTABLE IMPLANT (P050037/S064)Merz North America, Inc.2015-12-29
RADIESSE (+) LIDOCAINE DERMAL FILLER (P050052/S075)Merz North America, Inc.2015-12-29
RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK (P040024/S083)Q-Med AB2015-12-15
BELOTERO BALANCE (P090016/S018)Merz North America, Inc.2015-12-11
RADIESSE (P050037/S063)Merz North America, Inc.2015-12-11
RADIESSE, RADIESSE (+) [RADIESSE WITH LIDOCAINE] (P050052/S074)Merz North America, Inc.2015-12-11
SEPRAFILM ADHESION BARRIER (P950034/S043)Baxter Healthcare Corporation2015-12-03
ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R (P050038/S027)Davol, Inc.2015-12-02
SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S035)ETHICON, Inc.2015-11-27
COSEAL SURGICAL SEALANT, COSEAL REPLACEMENT APPLICATOR, COSEAL EXTENDED APPLICATOR (P030039/S019)Baxter Bio Science2015-11-24
RESTYLANE (P040024/S089)Q-Med AB2015-11-23
RADIESSE INJECTABLE IMPLANT (P050052/S069)Merz North America, Inc.2015-11-23
RESTYLANE-L (P040024/S088)Q-Med AB2015-11-23
SALINE-FILLED & SPECTRUM BREAST IMPLANTS (P990075/S034)Mentor Worldwide, LLC2015-11-20
MEMORYSHAPE BREAST IMPLANTS (P060028/S015)Mentor Worldwide, LLC2015-11-20
MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS (P030053/S032)Mentor Corp.2015-11-20
RADIESSE (P050037/S059)Merz North America, Inc.2015-11-12
RADIESSE, RADIESSE (+) (P050052/S065)Merz North America, Inc.2015-11-12
RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE (P040024/S087)Q-Med AB2015-11-06
HYDRELLE DERMAL FILLER (P050033/S018)Anika Therapeutics, Inc.2015-11-03
RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORATION AND OR CORRECTION FOR THE SIGNS OF FACIAL FAT LO (P050037/S056)Merz North America, Inc.2015-10-28
RADIESSE, RADIESSE (+), RADIESSE WITH LIDOCAINE INJECTABLE IMPLANT (P050052/S062)Merz North America, Inc.2015-10-28
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S051)Allergan2015-10-23
MELAFIND (P090012/S004)Strata Skin Sciences, Inc.2015-10-22
HYDRELLE (P050033/S020)Anika Therapeutics, Inc.2015-10-22
JUVEDERM VOLUMA XC (P110033/S015)Allergan2015-10-06
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S048)Allergan2015-10-06
RADIESSE (P050037/S062)Merz North America, Inc.2015-10-01
RADIESSE, RADIESSE(+), RADIESSE (P050052/S072)Merz North America, Inc.2015-10-01
JUVEDERM ULTRA XC INJECTABLE GEL (P050047/S044)Allergan2015-09-30
JUVEDERM VOLUMA XC (P110033/S019)Allergan2015-09-30
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S050)Allergan2015-09-30
RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK (P040024/S084)Q-Med AB2015-09-25
RESTYLANE, RESTYLANE-L, PERLANE, PERLANE-L, RESTYLANE SILK (P040024/S085)Q-Med AB2015-09-25
RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE LYFT, RESTYLANE SILK (P040024/S082)Q-Med AB2015-09-24
MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS (P030053/S030)Mentor Corp.2015-09-24
ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R (P050038/S026)Davol, Inc.2015-09-09
RADIESSE INJECTABLE IMPLANT (P050052/S070)Merz North America, Inc.2015-09-02
RESTYLANE, RESTYLANE-L, PERLANE, RESTYLANE LYFT, RESTYLANE SILK (P040024/S081)Q-Med AB2015-08-31
IDEAL IMPLANT SALINE FILLED BREAST IMPLANT (P120011/S001)Bimini Health Tech2015-08-27
FLOSEAL HEMOSTATIC MATRIX (P990009/S040)Baxter Healthcare Corp2015-08-21
BELLAFILL PMMA COLLAGEN DERMAL FILLER (P020012/S011)Tiger Aesthetics Medical, LLC2015-08-07
BELOTERO BALANCE (P090016/S016)Merz North America, Inc.2015-08-06
INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE (P900033/S047)Integra Lifesciences Corp.2015-08-06
BELOTERO BALANCE (P090016/S009)Merz North America, Inc.2015-08-06
NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED BREAST IMPLANTS (P040046/S013)Allergan2015-08-05
RADIESSE DERMAL FILLER (P050037/S061)Merz North America, Inc.2015-08-05
RADIESSE, RADIESSE (+) (P050052/S071)Merz North America, Inc.2015-08-05
NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S023)Allergan2015-08-03
NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS (P040046/S012)Allergan2015-08-03
ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R (P050038/S025)Davol, Inc.2015-07-31
RADIESSE (P050052/S068)Merz North America, Inc.2015-07-24
RADIESSE (P050037/S060)Merz North America, Inc.2015-07-24
COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE (P130023/S001)Cohera Medical, Inc.2015-07-17
FLOSEAL HEMOSTATIC MATRIX (P990009/S041)Baxter Healthcare Corp2015-07-16
VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032)Stryker Corp.2015-07-16
RADIESSE (+) 1.5CC, RADIESSE (+) 0.8CC (P050052/S067)Merz North America, Inc.2015-07-06
BELOTERO BALANCE (P090016/S017)Merz North America, Inc.2015-07-02
MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S029)Mentor Corp.2015-07-01
MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S012)Mentor Worldwide, LLC2015-07-01
RESTYLANE, RESTYLANE-L,PERLANE,PERLANE-L,RESTYLANE SILK (P040024/S073)Q-Med AB2015-07-01
MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT (P990075/S033)Mentor Worldwide, LLC2015-07-01
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S048)Integra Lifesciences Corp.2015-06-25
ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/ FLEXITIP XL-R (P050038/S024)Davol, Inc.2015-06-24
JUVEDERM VOLUMA XC (P110033/S016)Allergan2015-06-10
SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S034)ETHICON, Inc.2015-06-04
RADIESSE INJECTABLE IMPLANT (P050052/S049)Merz North America, Inc.2015-06-04
NATRELLE INSPIRA BREAST IMPLANTS (P020056/S031)Allergan2015-06-03
RADIESSE (+) 0.8CC, RADIESSE (+) 1.5CC (P050052/S066)Merz North America, Inc.2015-06-03
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S047)Allergan2015-05-22
JUVEDERM VOLUMA XC (P110033/S014)Allergan2015-05-22
MARGINPROBE SYSTEM (P110014/S005)Dilon Medical Technologies, Ltd.2015-05-18
MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S028)Mentor Corp.2015-05-08
MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S011)Mentor Worldwide, LLC2015-05-08
RADIESSE AND RADIESSE(+) (P050052/S064)Merz North America, Inc.2015-05-06
RADIESSE (P050037/S058)Merz North America, Inc.2015-05-06
RADIESSE DERMAL FILLER (P050037/S057)Merz North America, Inc.2015-04-29
MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS (P990075/S032)Mentor Worldwide, LLC2015-04-29
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S064)Integra LifeSciences Corporation2015-04-29
MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S027)Mentor Corp.2015-04-29
RADIESSE & RADIESSE (+) DERMAL FILLER (P050052/S063)Merz North America, Inc.2015-04-29
MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S010)Mentor Worldwide, LLC2015-04-29
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM (P810006/S065)Integra LifeSciences Corporation2015-04-29
BOLOTERO BALANCE INJECTABLE DERMAL FILLER (P090016/S015)Merz North America, Inc.2015-04-29
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S064)Integra LifeSciences Corporation2015-04-22
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S046)Integra Lifesciences Corp.2015-04-22
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S063)Integra LifeSciences Corporation2015-04-22
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S040)Allergan2015-04-17
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM (P810006/S063)Integra LifeSciences Corporation2015-04-16
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S062)Integra LifeSciences Corporation2015-04-16
MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S026)Mentor Corp.2015-04-15
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P810006/S062)Integra LifeSciences Corporation2015-04-14
VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031)Stryker Corp.2015-04-14
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S061)Integra LifeSciences Corporation2015-04-14
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S045)Integra Lifesciences Corp.2015-04-14
VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030)Stryker Corp.2015-04-13
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