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General, Plastic Surgery

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

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RecordFirmDate
Gel-Flow NT (N18286/S030)Pfizer, Inc.2018-04-13
Bella Skin Test Tray (P020012/S024)Tiger Aesthetics Medical, LLC2018-04-13
Bellafill Dermal Filler (P020012/S023)Tiger Aesthetics Medical, LLC2018-04-11
Hemoblast Bellows (P170012/S002)Dilon Technologies, Inc.2018-04-10
Gelfoam Sterile Sponge (N18286/S031)Pfizer, Inc.2018-04-09
Bellafil Dermal Filler (P020012/S022)Tiger Aesthetics Medical, LLC2018-04-05
Juvederm Injectable Gel Implants (P110033/S037)Allergan2018-04-05
Integra Dermal Regeneration Template (P900033/S068)Integra Lifesciences Corp.2018-04-05
Juvederm Injectable Gel Implants (P050047/S063)Allergan2018-04-05
Belotero Balance Dermal Filler (P090016/S027)Merz North America, Inc.2018-04-03
Belotero Balance Dermal Filler (P090016/S026)Merz North America, Inc.2018-04-02
Radiesse Hands, Radiesse (+) Lidocaine (P050052/S098)Merz North America, Inc.2018-03-28
Belotero Balance Dermal Filler (P090016/S025)Merz North America, Inc.2018-03-28
Radiesse Injectable Implant (P050037/S082)Merz North America, Inc.2018-03-28
Bellafill Dermal Filler (P020012/S019)Tiger Aesthetics Medical, LLC2018-03-21
IDEAL IMPLANT Structured Breast Implant (P120011/S009)Bimini Health Tech2018-03-13
Seprafilm Adhesion Barrier (P950034/S050)Baxter Healthcare Corporation2018-03-09
GELFOAM (N18286/S028)Pfizer, Inc.2018-03-01
Integra Dermal Regeneration Template (P900033/S065)Integra Lifesciences Corp.2018-03-01
SURGICEL Powder Absorbable Hemostatic Powder (N12159/S046)ETHICON, Inc.2018-02-23
Juvederm Injectable Gel Implants (P110033/S036)Allergan2018-02-21
Juvederm Injectable Gel Implants (P050047/S062)Allergan2018-02-21
Radiessee Injectable Implant (P050037/S086)Merz North America, Inc.2018-02-12
Radiesse Lidocaine Dermal Filler (P050052/S102)Merz North America, Inc.2018-02-12
Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form (P850010/S079)Integra LifeSciences Corporation2018-02-09
Collastat Absorable Collagen Hemostatic Sponge and Collastat Absorable Collagen Hemostatic Agent Microfibrillar Form (P810006/S080)Integra LifeSciences Corporation2018-02-09
Restylane Refyne, Restylane Defyne (P140029/S004)Q-Med AB2018-01-31
OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES) (P940010/S014)Pinnacle Biologics, Inc.2018-01-30
Sientra Silicone Gel Breast Implants (P070004/S009)Tiger Aesthetics Medical, LLC2018-01-30
MemoryGel Silicone Gel-Filled Breast Implants (P030053/S045)Mentor Corp.2018-01-30
Exablate 2100/2100 VI System (P110039/S008)Insightec2018-01-25
Sientra OPUS Silicone Gel Breast Implants (P070004/S014)Tiger Aesthetics Medical, LLC2018-01-19
PHOTOFRIN 630 PDT Laser (P990021/S004)Pinnacle Biologics, Inc.2018-01-17
OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series) (P940010/S012)Pinnacle Biologics, Inc.2018-01-17
Optiguide Cylindrical Fiber Optic (P940010/S013)Pinnacle Biologics, Inc.2018-01-13
Sientra Silicone Breast Implants (P070004/S012)Tiger Aesthetics Medical, LLC2018-01-10
Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC (P110033/S033)Allergan2018-01-04
RADIESSE Lidocaine Dermal Filler (P050052/S092)Merz North America, Inc.2018-01-02
Bellafill Dermal Filler (P020012/S017)Tiger Aesthetics Medical, LLC2018-01-02
Integra Dermal Regeneration Template (P900033/S067)Integra Lifesciences Corp.2018-01-02
RADIESSE Injectable Implant (P050037/S078)Merz North America, Inc.2018-01-02
Gelfoam (absorbable gelatin)Sterile Sponge (N18286/S029)Pfizer, Inc.2018-01-02
HEMOBLAST™ Bellows (P170012)Dilon Technologies, Inc.2017-12-15
Juvederm Volbella XC (P110033/S035)Allergan2017-12-14
SCULPTRA & SCULPTRA Aesthetic (P030050/S027)Q-Med AB2017-12-14
Mentor-Saline-Filled and Spectrum Breast Implants (P990075/S043)Mentor Worldwide, LLC2017-12-06
Mentor MemoryShape Breast Implants (P060028/S027)Mentor Worldwide, LLC2017-12-06
Mentor MemoryGel Breast Implants (P030053/S044)Mentor Corp.2017-12-06
Sientra OPUS Silicone Gel Breast Implants (P070004/S010)Tiger Aesthetics Medical, LLC2017-12-01
RADIESSE (+) Lidocaine Dermal Filler (P050052/S099)Merz North America, Inc.2017-11-30
Sientra Silicone Gel Breast Implants (P070004/S011)Tiger Aesthetics Medical, LLC2017-11-30
RADIESSE Injectable Implant (P050037/S083)Merz North America, Inc.2017-11-30
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template andIntegra Omnigraft Dermal Regenerati (P900033/S066)Integra Lifesciences Corp.2017-11-28
Radiesse (+) Lidocaine Dermal Filler (P050052/S100)Merz North America, Inc.2017-11-21
Radiesse Injectable Implant (P050037/S084)Merz North America, Inc.2017-11-21
Ideal Implant Saline-filled Breast Implant (P120011/S010)Bimini Health Tech2017-11-17
Restylane / Perlane / Restylane-L / Restylane-Lyft(formerly Perlane-L) Restylane Silk. (P040024/S100)Q-Med AB2017-11-17
Juvederm Ultra, Juvederm Ultra XC, Juvederm Ultra Plus, Juvederm Ultra XC, Juvederm 30 (Juvederm Forma) (P050047/S061)Allergan2017-11-16
Juvederm Voluma XC, Juvederm Vollure XC, Juvederm Volbella XC (P110033/S034)Allergan2017-11-16
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S049)Baxter Healthcare Corp2017-11-09
Floseal Hemostatic Matrix (P990009/S048)Baxter Healthcare Corp2017-11-08
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S026)Allergan2017-11-03
Natrelle Silicone-Filled Breast Implants (P020056/S045)Allergan2017-11-03
Natrelle Saline-Filled Breast Implants (P990074/S041)Allergan2017-11-03
FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips (P990009/S050)Baxter Healthcare Corp2017-11-01
Juvederm Volbella XC (P110033/S031)Allergan2017-10-27
Collastat Absorbable Collagen Hemostatic Sponge and COLLASTAT Absorbable Collagen Hemostatic Agemt- Microfibrillar Form (P810006/S078)Integra LifeSciences Corporation2017-10-25
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form (P850010/S077)Integra LifeSciences Corporation2017-10-25
Seprafilm Adhesion Barrier (P950034/S049)Baxter Healthcare Corporation2017-10-25
RHA 2, RHA 3, RHA 4 (P170002)Teoxane S.A.2017-10-19
NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S022)Allergan2017-10-13
NATRELLE Saline-Filled Breast Implants (P990074/S038)Allergan2017-10-13
NATRELLE Silicone Filled Breast Implants (P020056/S041)Allergan2017-10-13
Restylane Silk (P040024/S096)Q-Med AB2017-10-11
Mentor MemoryGel Silicone Gel - Filled Breast Implants (P030053/S043)Mentor Corp.2017-10-10
Revanesse Ultra (Revanesse Versa) (P160042/S001)Prollenium Medical Technologies, Inc.2017-10-02
Bellafill Dermal Filler (P020012/S015)Tiger Aesthetics Medical, LLC2017-09-28
Surgifoam Absorbable Gelatin Sponge, U.S.P. (P990004/S032)Ferrosan Meidcal Devices A/S2017-09-21
Radiesse Injectable Implant (P050052/S096)Merz North America, Inc.2017-09-18
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S063)Integra Lifesciences Corp.2017-09-08
Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028/S025)Mentor Worldwide, LLC2017-09-01
Collastat Absorbable Collagen Hemostatic Sponge and Agent-Microfibrillar Form (P810006/S077)Integra LifeSciences Corporation2017-08-31
Helistat, Helitene Absorbable Collagen Hemostatic Agents (P850010/S076)Integra LifeSciences Corporation2017-08-31
Radiesse (+) Lidocaine Injectable Implant (P050052/S097)Merz North America, Inc.2017-08-29
Seprafilm Adhesion Barrier (P950034/S048)Baxter Healthcare Corporation2017-08-29
Restylane-L, Restylane Lyft with Lidocaine, and Restylane Silk (P040024/S095)Q-Med AB2017-08-28
NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S021)Allergan2017-08-28
NATRELLE Silicon-Filled Breast Implants (P020056/S040)Allergan2017-08-28
NATRELLE Saline-Filled Breast Implants (P990074/S037)Allergan2017-08-28
Voluma XC, Vollure XC, Volbella XC (P110033/S028)Allergan2017-08-25
PreveLeak Surgical Sealant (P100030/S007)Baxter Healthcare Corporation2017-08-25
Juvéderm Ultra, Ultra XC, Ultra, Juvéderm Ultra XC (P050047/S058)Allergan2017-08-25
NATRELLE Silicone-Filled Breast Implants (P020056/S044)Allergan2017-08-21
NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S025)Allergan2017-08-21
NATRELLE Saline-Filled Breast Implants (P990074/S040)Allergan2017-08-21
Spectrum Saline Breast Implants (P990075/S042)Mentor Worldwide, LLC2017-08-09
Restylane Injectable Gels (P040024/S098)Q-Med AB2017-08-09
REVANESSE ULTRA (P160042)Prollenium Medical Technologies, Inc.2017-08-04
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S024)Allergan2017-08-01
Restylane, Perlane, Restylane-L, Restylane Lyft (formerly Perlane-L), Restylane Silk (P040024/S097)Q-Med AB2017-08-01
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