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General, Plastic Surgery

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

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RecordFirmDate
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
SURGICEL® Absorbable Hemostats (N12159/S119)ETHICON, Inc.2025-01-30
Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S092)Allergan2025-01-29
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC (P050047/S099)Allergan2025-01-29
SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S070)Ferrosan Meidcal Devices A/S2025-01-27
MemoryGel Enhance Silicone Breast Implants (P030053/S076)Mentor Corp.2025-01-17
Juvederm Voluma XC (P110033/S090)Allergan2025-01-17
RHA 3 Mepi (P170002/S043)Teoxane S.A.2025-01-17
Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine (P090016/S065)Merz North America, Inc.2025-01-15
Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S114)Integra LifeSciences Corporation2025-01-14
Belotero Balance (+) Lidocaine Dermal Filler (P090016/S064)Merz North America, Inc.2025-01-08
Bellafill Dermal Filler (P020012/S048)Tiger Aesthetics Medical, LLC2025-01-07
Lumicell Direct Visualization System (DVS) (P230014/S003)Lumicell, Inc.2025-01-03
SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S067)Ferrosan Meidcal Devices A/S2024-12-30
PerClot Polysaccharide Hemostatic System (P210036/S002)Baxter Healthcare Corporation2024-12-20
SURGICEL Absorbable Hemostats (N12159/S118)ETHICON, Inc.2024-12-19
Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
Avitene Flowable Collagen Hemostat (N17600/S040)Davol Inc., Sub. C. R. Bard, Inc.2024-12-18
NATRELLE Silicone-Filled Breast Implants (P020056/S065)Allergan2024-12-16
NATRELLE Saline-Filled Breast Implants (P990074/S054)Allergan2024-12-16
SURGICEL Powder Absorbable Hemostats (N12159/S116)ETHICON, Inc.2024-12-13
Juvederm (P110033/S088)Allergan2024-12-12
Juvederm (P050047/S097)Allergan2024-12-12
RADIESSE Injectable Implant (P050037/S141)Merz North America, Inc.2024-12-11
RADIESSE Injectable Implant, RADIESSE Hands, RADIESSE (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S165)Merz North America, Inc.2024-12-11
RHA® Redensity™, RHA®2, RHA®3, RHA®4 (P170002/S047)Teoxane S.A.2024-12-10
Belotero Balance (+) Lidocaine Dermal Filler (P090016/S062)Merz North America, Inc.2024-12-10
SURGICEL Absorbable Hemostats (SURGICEL Endoscopic Applicator) (N12159/S117)ETHICON, Inc.2024-12-05
Mentor® MemoryGel® Silicone Gel-Filled Breast Implants (P030053/S071)Mentor Corp.2024-12-04
Mentor® MemoryShape® Breast Implants (P060028/S050)Mentor Worldwide, LLC2024-12-04
Mentor® Saline-Filled and SPECTRUM® Breast Implants (P990075/S059)Mentor Worldwide, LLC2024-12-04
Lumicell Direct Visualization System (P230014/S002)Lumicell, Inc.2024-11-26
MENTOR MemoryGel Breast Implants (P030053/S075)Mentor Corp.2024-11-26
MENTOR Saline-Filled and SPECTRUM Breast Implants (P990075/S061)Mentor Worldwide, LLC2024-11-26
MENTOR MemoryShape Breast Implants (P060028/S053)Mentor Worldwide, LLC2024-11-26
MemoryGel® Ultra High Profile - Extended Range (UH-R) Breast Implants (P030053/S069)Mentor Corp.2024-11-22
Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas (P230005/S001)Motiva USA, LLC2024-11-22
SCULPTRA (injectable poly-L Lactic acid) (P030050/S053)Q-Med AB2024-11-13
MemoryGel, MemoryGel Xtra Silicone Gel-Filled Breast Implants (P030053/S058)Mentor Corp.2024-11-08
HEMOBLAST™ Bellows (P170012/S029)Dilon Technologies, Inc.2024-11-06
Mentor MemoryGel® Silicone Gel-Filled Breast Implant PMA (P030053/S074)Mentor Corp.2024-11-05
Mentor MemoryShape® Silicone Gel-Filled Breast Implant PMA (P060028/S052)Mentor Worldwide, LLC2024-11-05
Arista AH (P050038/S042)Davol, Inc.2024-11-04
Juvederm Volux XC (P110033/S089)Allergan2024-10-29
RHA® Redensity™, RHA®2, RHA®3, RHA®4 (P170002/S046)Teoxane S.A.2024-10-23
RHA® Redensity™, RHA®2, RHA®3, RHA®4, RHA® Redensity™ Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi (P170002/S044)Teoxane S.A.2024-10-18
RHA® Redensity, RHA® Redensity Mepi (P170002/S045)Teoxane S.A.2024-10-18
SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S069)Ferrosan Meidcal Devices A/S2024-10-15
SCULPTRA (P030050/S051)Q-Med AB2024-10-09
Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler (P090016/S063)Merz North America, Inc.2024-10-07
Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine Dermal Filler (P090016/S061)Merz North America, Inc.2024-10-02
SCULPTRA® (injectable poly-L Lactic acid) (P030050/S052)Q-Med AB2024-10-02
Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas (P230005)Motiva USA, LLC2024-09-26
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S147)Merz North America, Inc.2024-09-23
RADIESSE® Injectable Implant (P050037/S125)Merz North America, Inc.2024-09-23
Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S087)Allergan2024-09-04
Ultra, Ultra XC, Ultra Plus XC (P050047/S096)Allergan2024-09-04
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form (P810006/S110)Integra LifeSciences Corporation2024-08-29
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form (P850010/S113)Integra LifeSciences Corporation2024-08-29
SURGICEL® Absorbable Hemostats (SURGICEL® SNOW™) (N12159/S115)ETHICON, Inc.2024-08-28
RHA® Redensity, RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi (P170002/S042)Teoxane S.A.2024-08-27
SURGICEL® Absorbable Hemostats (N12159/S114)ETHICON, Inc.2024-08-27
Collastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S109)Integra LifeSciences Corporation2024-08-22
SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S068)Ferrosan Meidcal Devices A/S2024-08-22
Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S112)Integra LifeSciences Corporation2024-08-22
Sientra Silicone Gel Breast Implants (P070004/S044)Tiger Aesthetics Medical, LLC2024-08-21
Revanesse Versa; Revanesse Versa+ with Lidocaine, Revanesse Versa+ with Lidocaine 1.2 mL, Revanesse® Versa™ 1.2 mL, Reva (P160042/S024)Prollenium Medical Technologies, Inc.2024-08-20
Puregraft Serene Breast Implant (P120011/S025)Bimini Health Tech2024-08-16
NATRELLE Silicone-Filled Breast Implants (P020056/S050)Allergan2024-08-16
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Sientra Silicone Gel Breast Implants (P070004/S046)Tiger Aesthetics Medical, LLC2024-08-15
RADIESSE® Injectable Implant (P050037/S129)Merz North America, Inc.2024-08-12
Sientra Silicone Gel Breast Implants (P070004/S043)Tiger Aesthetics Medical, LLC2024-08-12
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE®(+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S151)Merz North America, Inc.2024-08-12
RHA® Redensity™, RHA® 2, RHA® 3, RHA® 4 (P170002/S037)Teoxane S.A.2024-07-31
Collastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I (P810006/S108)Integra LifeSciences Corporation2024-07-24
Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent-Fibrillar Form (P850010/S111)Integra LifeSciences Corporation2024-07-24
PerClot Polysaccharide Hemostatic System (P210036/S004)Baxter Healthcare Corporation2024-07-18
Restylane® Contour (P140029/S051)Q-Med AB2024-07-17
Sientra Silicone Gel Breast Implants (P070004/S039)Tiger Aesthetics Medical, LLC2024-07-16
Revanesse Versa, Revanesse Versa+ and Revanesse Lips+ (P160042/S026)Prollenium Medical Technologies, Inc.2024-07-12
RADIESSE Injectable Implant (P050037/S140)Merz North America, Inc.2024-07-10
RADIESSE® Injectable Implant, RADIESSE Hands (P050052/S164)Merz North America, Inc.2024-07-10
Belotero Balance(+) Lidocaine Dermal Filler (BBL) (P090016/S060)Merz North America, Inc.2024-07-05
Seprafilm Adhesion Barrier (P950034/S058)Baxter Healthcare Corporation2024-07-03
Magtrace® and Sentimag® Magnetic Locatization System (PUV) (P160053/S011)Endomagnetics Ltd.,2024-07-03
RHA® Redensity™, RHA® Redensity™ Mepi, RHA®2, RHA®2 Mepi, RHA®3, RHA®3 Mepi, RHA®4, RHA®4 Mepi (P170002/S035)Teoxane S.A.2024-06-27
Radiesse (+) Lidocaine dermal filler (P050052/S163)Merz North America, Inc.2024-06-25
Juvederm Volux XC (P110033/S082)Allergan2024-06-24
Juvederm, Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S086)Allergan2024-06-21
NATRELLE® Saline-Filled Breast Implants (P990074/S053)Allergan2024-06-21
NATRELLE® Silicone-Filled Breast Implants (P020056/S063)Allergan2024-06-21
Revanesse Versa, Revanesse Versa+ (with lidocaine), Revanesse Lips+ (with lidocaine) (P160042/S016)Prollenium Medical Technologies, Inc.2024-06-21
Ultra, Ultra XC, Ultra Plus XC (P050047/S095)Allergan2024-06-21
RADIESSE® Injectable Implant (P050037/S139)Merz North America, Inc.2024-06-18
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S161)Merz North America, Inc.2024-06-18
SURGICEL® Absorbable Hemostats (N12159/S113)ETHICON, Inc.2024-06-13
SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S064)Ferrosan Meidcal Devices A/S2024-06-13
Revanesse Versa; Revanesse Versa+ with Lidocaine; Revanesse Versa+ with Lidocaine 1.2 mL; Revanesse Versa 1.2 mL, Revan (P160042/S025)Prollenium Medical Technologies, Inc.2024-06-11
Magtrace and Sentimag Magnetic Locatization System (PUV) (P160053/S010)Endomagnetics Ltd.,2024-06-07
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