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General, Plastic Surgery

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

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RecordFirmDate
Floseal Hemostatic Matrix (FLOSEAL) (P990009/S068)Baxter Healthcare Corp2021-12-10
MENTOR MemoryShape Breast Implants (P060028/S042)Mentor Worldwide, LLC2021-12-10
MemoryGel BOOST Moderate Plus Profile Breast Implants and MemoryGel BOOST High Profile BOOST Breast Implants (P030053/S051)Mentor Corp.2021-12-10
MENTOR MemoryGel Breast Implants (P030053/S063)Mentor Corp.2021-12-10
Restylane® Refyne, Restylane® Defyne, Restylane® Kysse, Restylane® Contour (P140029/S044)Q-Med AB2021-12-09
Restylane® Injectable Gel (P040024/S128)Q-Med AB2021-12-09
Belotero Balance + Lidocaine Dermal Filler, Belotero Balance Dermal Filler (P090016/S045)Merz North America, Inc.2021-12-08
Belotero Balance + Lidocaine Dermal Filler, Belotero Balance Dermal Filler (P090016/S044)Merz North America, Inc.2021-12-08
Restylane Contour (P140029/S043)Q-Med AB2021-11-30
Sculptra and Sculptra Aesthetic (P030050/S034)Q-Med AB2021-11-23
Restylane, Restylane Lyft with Lidocaine, Restylane Silk, Restylane-L, Perlane (P040024/S123)Q-Med AB2021-11-16
INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S095)Integra Lifesciences Corp.2021-11-13
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S096)Integra LifeSciences Corporation2021-11-13
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S098)Integra LifeSciences Corporation2021-11-13
HEMOBLAST™ Bellows (P170012/S026)Dilon Technologies, Inc.2021-10-28
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S050)Ferrosan Meidcal Devices A/S2021-10-28
MemoryGel/MemoryGel Xtra Breast Implants (P030053/S062)Mentor Corp.2021-10-27
Sientra OPUS Silicone Gel Breast Implants (P070004/S033)Tiger Aesthetics Medical, LLC2021-10-27
Natrelle Saline Filled Breast Implants (P990074/S045)Allergan2021-10-27
Natrelle Silicone Filled Breast Implants (P020056/S054)Allergan2021-10-27
MemoryShape Breast Implants (P060028/S041)Mentor Worldwide, LLC2021-10-27
Saline-Filled and Spectrum Breast Implants (P990075/S051)Mentor Worldwide, LLC2021-10-27
Restylane Refyne, Restylane Defyne, Restylane Kysse, Restylane Contour (P140029/S042)Q-Med AB2021-10-27
IDEAL IMPLANT Structured Breast Implant (P120011/S022)Bimini Health Tech2021-10-27
Arista™ AH Absorbable Hemostatic Particles device (P050038/S038)Davol, Inc.2021-10-22
RESTYLANE® Injectable Gels (P040024/S124)Q-Med AB2021-10-22
RHA®4 Dermal Filler (P170002/S019)Teoxane S.A.2021-10-22
RADIESSE (+) Lidocaine Implant (P050052/S132)Merz North America, Inc.2021-10-21
SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat , SURGICEL™ Fibrillar Absorbable Hemostat, (N12159/S087)ETHICON, Inc.2021-10-21
RADIESSE Implant (P050037/S112)Merz North America, Inc.2021-10-21
Restylane Refyne, Restylane Defyne, Restylane Kysse (P140029/S040)Q-Med AB2021-10-19
SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S039)Ferrosan Meidcal Devices A/S2021-10-19
HEMOBLAST™ Bellows (P170012/S027)Dilon Technologies, Inc.2021-10-13
Belotero Balance + Lidocaine (P090016/S046)Merz North America, Inc.2021-10-13
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S097)Integra LifeSciences Corporation2021-10-07
SURGICEL® SNoW™ Absorbable Hemostat (N12159/S084)ETHICON, Inc.2021-09-30
Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S059)Mentor Corp.2021-09-24
Mentor MemoryShape Breast Implants (P060028/S038)Mentor Worldwide, LLC2021-09-24
Sientra Opus Silicone Gel Breast Implants (P070004/S029)Tiger Aesthetics Medical, LLC2021-09-23
Magtrace/and Sentimag Magnetic Localization System (P160053/S004)Endomagnetics Ltd.,2021-09-20
SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat, (N12159/S083)ETHICON, Inc.2021-09-10
Juvéderm® Volbella™ XC (P110033/S062)Allergan2021-09-10
INTEGRA Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S094)Integra Lifesciences Corp.2021-09-07
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S095)Integra LifeSciences Corporation2021-09-07
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S095)Integra LifeSciences Corporation2021-09-07
Radiesse (+) Injectable Implant (P050052/S129)Merz North America, Inc.2021-09-01
SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SUR (N12159/S082)ETHICON, Inc.2021-08-31
RADIESSE Injectable Implant (P050037/S110)Merz North America, Inc.2021-08-27
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S128)Merz North America, Inc.2021-08-27
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S049)Ferrosan Meidcal Devices A/S2021-08-25
Restylane Injectable Gel (P040024/S126)Q-Med AB2021-08-25
Arista AH Absorbable Hemostatic Particles Device (P050038/S039)Davol, Inc.2021-08-20
SURGICEL Absorbable Hemostats (N12159/S081)ETHICON, Inc.2021-08-16
SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S045)Ferrosan Meidcal Devices A/S2021-08-13
RHA 2, RHA 3, RHA Dermal Fillers (P170002/S018)Teoxane S.A.2021-08-13
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S097)Integra LifeSciences Corporation2021-08-12
Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S097)Integra Lifesciences Corp.2021-08-12
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S099)Integra LifeSciences Corporation2021-08-12
SURGICEL NU-KNIT Absorbable Hemostat (N12159/S080)ETHICON, Inc.2021-07-30
NATRELLE Saline-Filled Breast Implants (P990074/S048)Allergan2021-07-30
NATRELLE Silicone-Filled Breast Implants (P020056/S057)Allergan2021-07-30
NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S031)Allergan2021-07-26
Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S064)Mentor Corp.2021-07-22
Mentor MemoryShape Breast Implants (P060028/S043)Mentor Worldwide, LLC2021-07-22
Juvéderm Hyaluronate Gel Implants (P050047/S082)Allergan2021-07-21
Juvederm Gel Implants (P050047/S080)Allergan2021-07-21
Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC (P110033/S061)Allergan2021-07-21
Juvederm injectable Gel (P110033/S058)Allergan2021-07-21
Mentor Saline-Filled and Spectrum Breast Implants (P990075/S052)Mentor Worldwide, LLC2021-07-21
NATRELLE Saline-Filled Breast Implants (P990074/S047)Allergan2021-07-20
NATRELLE Silicone-Filled Breast Implants (P020056/S056)Allergan2021-07-20
Integra Dermal Regeneration Template and Intergra Meshed Dermal Regeneration Template (P900033/S096)Integra Lifesciences Corp.2021-07-09
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039)Pfizer, Inc.2021-07-08
Arista AH Absorbable Hemostatic Particles (P050038/S037)Davol, Inc.2021-07-06
IDEAL IMPLANT Structured Breast Implant (P120011/S021)Bimini Health Tech2021-06-29
Restylane® Contour (P140029/S032)Q-Med AB2021-06-28
NATRELLE Silicone-Filled Breast Implants (P990074/S046)Allergan2021-06-25
NATRELLE Saline-Filled Breast Implants (P020056/S055)Allergan2021-06-25
RADIESSE (+) Lidocaine Dermal Filler (P050052/S131)Merz North America, Inc.2021-06-25
Juvéderm Hyaluronate Gel Implants (P050047/S081)Allergan2021-06-23
Juvéderm Hyaluronate Gel Implants (P110033/S060)Allergan2021-06-23
SURGIFLO Hemostatic Matrix Kit with Thrombin (P990004/S044)Ferrosan Meidcal Devices A/S2021-06-18
Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S035)Q-Med AB2021-06-11
Seprafilm Adhesion Barrier (P950034/S053)Baxter Healthcare Corporation2021-06-09
Radiesse Injectable Implant and Radiesse Hands (P050052/S130)Merz North America, Inc.2021-06-08
Radiesse Injectable Implant (P050037/S111)Merz North America, Inc.2021-06-08
Bellafill Dermal Filler (P020012/S037)Tiger Aesthetics Medical, LLC2021-06-08
Mentor Saline-Filled and Spectrum Breast Implants (P990075/S050)Mentor Worldwide, LLC2021-06-04
Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S060)Mentor Corp.2021-06-04
Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S061)Mentor Corp.2021-06-04
Mentor MemoryShape Breast Implants (P060028/S040)Mentor Worldwide, LLC2021-06-04
Mentor MemoryShape Breast Implants (P060028/S039)Mentor Worldwide, LLC2021-06-04
SURGIFOAM Absorbable Gelation Sponge, U.S.P. (P990004/S048)Ferrosan Meidcal Devices A/S2021-06-02
Juvederm Volbella XC (P110033/S053)Allergan2021-05-28
RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S017)Teoxane S.A.2021-05-26
SCULPTRA (injectable poly-L Lactic acid) and SCULPTRA Aesthetic (injectable poly-L Lactic acid) (P030050/S032)Q-Med AB2021-05-18
Bellafill Dermal Filler (P020012/S038)Tiger Aesthetics Medical, LLC2021-05-14
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038)Pfizer, Inc.2021-05-07
Revanesse Lips+ 1.2 mL (P160042/S014)Prollenium Medical Technologies, Inc.2021-05-07
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidectomy Sponge/Oral Sponge and SURGIFOAM® Absorbable Gelatin Powd (P990004/S047)Ferrosan Meidcal Devices A/S2021-04-30
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