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General, Plastic Surgery

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

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RecordFirmDate
RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S016)Teoxane S.A.2021-04-30
Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S096)Integra LifeSciences Corporation2021-04-28
Sculptra and Sculptra Aesthetic (P030050/S036)Q-Med AB2021-04-28
RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S015)Teoxane S.A.2021-04-26
Revanesse Versa, Revanesse Versa+, Revanesse Lips+ (P160042/S015)Prollenium Medical Technologies, Inc.2021-04-16
RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S014)Teoxane S.A.2021-04-15
Restylane Kysse Injectable Gel (P140029/S037)Q-Med AB2021-04-14
Restylane Kysse Injectable Gel (P140029/S038)Q-Med AB2021-04-13
NATRELLE Silicone-Filled Breast Implants (P020056/S053)Allergan2021-04-10
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE (P950034/S052)Baxter Healthcare Corporation2021-04-01
SURGICEL Family of Absorbable Hemostats (N12159/S079)ETHICON, Inc.2021-04-01
SURGICEL FIBRILLAR Absorbable Hemostat and SURGICEL NU-KNIT Absorbable Hemostat (N12159/S078)ETHICON, Inc.2021-03-31
RHA 2, RHA 3, RHA 4 (P170002/S013)Teoxane S.A.2021-03-19
Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S036)Q-Med AB2021-03-03
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S094)Integra LifeSciences Corporation2021-02-26
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S093)Integra Lifesciences Corp.2021-02-26
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S094)Integra LifeSciences Corporation2021-02-26
HEMOBLAST Bellows (P170012/S025)Dilon Technologies, Inc.2021-02-25
OPTIGUIDE Cylindrical Fiber Optic (P940010/S017)Pinnacle Biologics, Inc.2021-02-24
Gelfoam Sterile Sponge (N18286/S037)Pfizer, Inc.2021-02-24
Avitene Microfibrillar Collagen Hemostat (P800002/S028)C.R. Bard, Inc.2021-02-17
Avitene Microfibrillar Collagen Hemostat (N17600/S035)Davol Inc., Sub. C. R. Bard, Inc.2021-02-17
RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S010)Teoxane S.A.2021-02-10
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S093)Integra LifeSciences Corporation2021-02-04
Collastat™ Absorbable Collagen Hemostatic Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S093)Integra LifeSciences Corporation2021-02-04
Restylane Defyne (P140029/S027)Q-Med AB2021-01-29
INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S092)Integra Lifesciences Corp.2021-01-19
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen hemostatic Agent - Fibrillar Form (P850010/S092)Integra LifeSciences Corporation2021-01-19
Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form (P810006/S092)Integra LifeSciences Corporation2021-01-19
HEMOBLAST Bellows (P170012/S024)Dilon Technologies, Inc.2021-01-13
Floseal Hemostatic Matrix (P990009/S065)Baxter Healthcare Corp2020-12-23
SURGICEL Absorbable Hemostat (N12159/S077)ETHICON, Inc.2020-12-22
Belotero Balance Dermal Filler, Belotero Balance + Lidocaine Dermal Filler (P090016/S042)Merz North America, Inc.2020-12-22
Restylane Kysse Injectable Gel (P140029/S029)Q-Med AB2020-12-21
MemoryGel Xtra Silicone Gel-Filled Breast Implant (P030053/S056)Mentor Corp.2020-12-21
Radiesse Injectable Implant and Radiesse (+) Lidocaine Dermal Filler (P050052/S116)Merz North America, Inc.2020-12-21
Radiesse Injectable Implant (P050037/S099)Merz North America, Inc.2020-12-21
SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid) (P030050/S033)Q-Med AB2020-12-18
Floseal Hemostatic Matrix (P990009/S061)Baxter Healthcare Corp2020-12-11
Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036)Pfizer, Inc.2020-12-10
Floseal Hemostatic Matrix (P990009/S064)Baxter Healthcare Corp2020-12-08
Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S031)Q-Med AB2020-12-04
Saline-Filled and Spectrum Breast Implants (P990075/S049)Mentor Worldwide, LLC2020-12-01
Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC (P110033/S057)Allergan2020-11-25
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, and Juvéderm Ultra Plus XC (P050047/S079)Allergan2020-11-25
IDEAL IMPLANT Structured Breast Implant (P120011/S017)Bimini Health Tech2020-11-19
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S091)Integra LifeSciences Corporation2020-11-18
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S091)Integra Lifesciences Corp.2020-11-18
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S091)Integra LifeSciences Corporation2020-11-18
SURGICEL Absorbable Hemostats (N12159/S076)ETHICON, Inc.2020-11-12
Restylane Refyne, Restylane Defyne, and Restylane Kysse (P140029/S034)Q-Med AB2020-11-06
Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, Restylane Silk (P040024/S121)Q-Med AB2020-11-06
SURGICEL Absorbable Hemostats (N12159/S075)ETHICON, Inc.2020-11-03
Mentor Saline-Filled and SPECTRUM Breast Implants (P990075/S048)Mentor Worldwide, LLC2020-10-30
Belotero Balance (P090016/S043)Merz North America, Inc.2020-10-29
Juvéderm Injectable Gel Implants (P110033/S056)Allergan2020-10-28
Juvéderm Injectable Gel Implants (P050047/S078)Allergan2020-10-28
Mentor Saline-Filled Breast Implants (P990075/S047)Mentor Worldwide, LLC2020-10-27
Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S055)Mentor Corp.2020-10-27
Mentor MemoryShape Breast Implants (P060028/S036)Mentor Worldwide, LLC2020-10-27
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S127)Merz North America, Inc.2020-10-23
RADIESSE Injectable Implant (P050037/S109)Merz North America, Inc.2020-10-23
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S125)Merz North America, Inc.2020-10-15
RADIESSE Injectable Implant (P050037/S107)Merz North America, Inc.2020-10-15
Restylane, Perlane, Restylane-L, Restylane Lyft with Lidocane and Restylane Silk Injectable Gels (P040024/S120)Q-Med AB2020-10-14
RADIESSE Injectable Implant, RADIESSE Hands and RADIESSE (+) Lidocaine Dermal Filler (P050052/S126)Merz North America, Inc.2020-10-14
RADIESSE Injectable Implant (P050037/S108)Merz North America, Inc.2020-10-14
Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S030)Q-Med AB2020-10-14
Revanesse Versa+ (P160042/S012)Prollenium Medical Technologies, Inc.2020-10-13
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regenera (P900033/S090)Integra Lifesciences Corp.2020-10-13
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S120)Merz North America, Inc.2020-10-02
BELOTERO BALANCE Dermal Filler, BELOTERO BALANCE (+) Lidocaine Dermal Filler (P090016/S037)Merz North America, Inc.2020-10-02
RADIESSE Injectable Implant (P050037/S102)Merz North America, Inc.2020-10-02
Restylane Injectable Gels (P040024/S117)Q-Med AB2020-10-01
SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S043)Ferrosan Meidcal Devices A/S2020-09-25
Arista AH Absorbable Hemostatic (P050038/S036)Davol, Inc.2020-09-25
SURGICEL FIBRILLAR Absorbable Hemostat (N12159/S073)ETHICON, Inc.2020-09-24
Revanesse® Lips+ (P160042/S010)Prollenium Medical Technologies, Inc.2020-09-21
SURGICEL Powder Absorbable Hemostatic Powder (N12159/S069)ETHICON, Inc.2020-09-21
HEMOBLAST Bellows (P170012/S023)Dilon Technologies, Inc.2020-09-11
Floseal Hemostatic Matrix (P990009/S062)Baxter Healthcare Corp2020-09-09
Integra Dermal Regeneration Template (P900033/S089)Integra Lifesciences Corp.2020-09-04
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostat Agent - Microfibrillar Form (P810006/S090)Integra LifeSciences Corporation2020-09-04
Helistat Absorbable Collagen Hemostatic Sponge (P850010/S090)Integra LifeSciences Corporation2020-09-04
Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels (P140029/S028)Q-Med AB2020-08-28
MemoryGel Silicone Gel-Filled Breast Implants (P030053/S053)Mentor Corp.2020-08-28
Floseal Hemostatic Matrix (P990009/S063)Baxter Healthcare Corp2020-08-28
SURGIFOAM Absorbable Gelatin Sponge U.S.P. (P990004/S042)Ferrosan Meidcal Devices A/S2020-08-27
SURGICEL Absorbable Hemostat (N12159/S074)ETHICON, Inc.2020-08-14
MarginProbe System (P110014/S011)Dilon Medical Technologies, Ltd.2020-08-14
Floseal Hemostatic Matrix (P990009/S058)Baxter Healthcare Corp2020-08-07
IDEAL IMPLANT Structured Breast Implant (P120011/S020)Bimini Health Tech2020-07-31
NATRELLE Silicon-Filled Breast Implants (P020056/S051)Allergan2020-07-30
NATRELLE Style 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S032)Allergan2020-07-30
NATRELLE Saline-Filled Breast Implants (P990074/S044)Allergan2020-07-30
RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S124)Merz North America, Inc.2020-07-30
RADIESSE Injectable Implant (P050037/S106)Merz North America, Inc.2020-07-30
SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S041)Ferrosan Meidcal Devices A/S2020-07-24
MemoryGel Breast Implant (P030053/S050)Mentor Corp.2020-07-17
Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC (P050047/S077)Allergan2020-07-17
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