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General, Plastic Surgery

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

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RecordFirmDate
RADIESSE® Injectable Implant (P050037/S121)Merz North America, Inc.2023-01-12
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S138)Merz North America, Inc.2023-01-06
RADIESSE® Injectable Implant (P050037/S117)Merz North America, Inc.2023-01-06
Sientra OPUS Silicone Gel Breast Implants (P070004/S016)Tiger Aesthetics Medical, LLC2023-01-03
NATRELLE Silicone-Filled Breast Implants (P020056/S059)Allergan2022-12-29
NATRELLE Saline-Filled Breast Implants (P990074/S050)Allergan2022-12-29
Restlyane® Refyne Injectable Gel (P140029/S047)Q-Med AB2022-12-23
Restylane® Silk Injectable Gel (P040024/S136)Q-Med AB2022-12-23
Seprafilm Adhesion Barrier (P950034/S055)Baxter Healthcare Corporation2022-12-22
SURGIFOAM Absorabable Gelatin Sponge, U.S.P., SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic MatrixKit with Thrombin (P990004/S055)Ferrosan Meidcal Devices A/S2022-12-21
SURGICEL® Absorbable Hemostats (N12159/S096)ETHICON, Inc.2022-12-20
Restylane Injectable Gel (P040024/S132)Q-Med AB2022-12-20
Restylane Refyne, Restylane Defyne, Restylane Kysse and Restylane Contour (P140029/S045)Q-Med AB2022-12-20
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S104)Integra LifeSciences Corporation2022-12-19
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar Fo (P810006/S101)Integra LifeSciences Corporation2022-12-19
RADIESSE® Injectable Implant (P050037/S120)Merz North America, Inc.2022-12-15
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S141)Merz North America, Inc.2022-12-15
INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S103)Integra Lifesciences Corp.2022-12-07
MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S002)Endomagnetics Ltd.,2022-12-06
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler (P050052/S140)Merz North America, Inc.2022-11-30
RADIESSE® Injectable Implant (P050037/S119)Merz North America, Inc.2022-11-30
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S139)Merz North America, Inc.2022-11-29
RADIESSE® Injectable Implant (P050037/S118)Merz North America, Inc.2022-11-29
Floseal Hemostatic Matrix, RT5 and RTl 0, Floseal Hemostatic Matrix, Fast Prep (P990009/S071)Baxter Healthcare Corp2022-11-22
Spectrum Breast Implants (P990075/S054)Mentor Worldwide, LLC2022-11-16
Belotero Balance (+) Lidocaine (P090016/S049)Merz North America, Inc.2022-10-26
Restylane-L; Restylane Lyft; Restylane Silk (P040024/S127)Q-Med AB2022-10-25
Sientra Silicone Gel Breast Implants (P070004/S036)Tiger Aesthetics Medical, LLC2022-10-06
NATRELLE Saline-Filled Breast Implants (P020056/S058)Allergan2022-10-05
NATRELLE Silicone-Filled Breast Implants (P990074/S049)Allergan2022-10-05
RESTYLANE® Family of Injectable Gels (P040024/S133)Q-Med AB2022-10-04
RESTYLANE® Family of Injectable Gels (P140029/S046)Q-Med AB2022-10-04
RESTYLANE® Injectable Gels (P040024/S134)Q-Med AB2022-09-30
MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S005)Endomagnetics Ltd.,2022-09-13
Belotero Balance(R) Dermal Filler (P090016/S034)Merz North America, Inc.2022-09-07
RADIESSE® Injectable Implant (P050037/S115)Merz North America, Inc.2022-09-02
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S136)Merz North America, Inc.2022-09-02
Voluma XC, Vollure XC, Volbella XC (P110033/S067)Allergan2022-08-05
Juvéderm Ultra, Ultra XC, Juvéderm Ultra XC (P050047/S086)Allergan2022-08-05
Bellafill® Dermal Filler (P020012/S041)Tiger Aesthetics Medical, LLC2022-08-05
Juvéderm Volux XC (P110033/S065)Allergan2022-07-29
SURGICEL™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat, (N12159/S086)ETHICON, Inc.2022-07-26
Sculptra and Sculptra Aesthetic (P030050/S035)Q-Med AB2022-07-25
Restylane Injectable Gels (P040024/S131)Q-Med AB2022-07-20
Sientra OPUS® Silicone Gel Breast Implants (P070004/S037)Tiger Aesthetics Medical, LLC2022-07-20
SURGICELTM Family of Absorbable Hemostats (N12159/S094)ETHICON, Inc.2022-07-08
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S103)Integra LifeSciences Corporation2022-07-06
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S100)Integra LifeSciences Corporation2022-07-06
Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene (P900033/S101)Integra Lifesciences Corp.2022-07-06
Sientra OPUS Silicone Gel Breast Implants (P070004/S035)Tiger Aesthetics Medical, LLC2022-07-05
INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template (P900033/S102)Integra Lifesciences Corp.2022-07-01
Sculptra, Sculptra Aesthetic (P030050/S037)Q-Med AB2022-06-27
(Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040)Pfizer, Inc.2022-06-24
RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers (P170002/S021)Teoxane S.A.2022-06-14
Restylane Refyne, Restylane Defyne and Restylane Kysse (injectable gels) (P140029/S033)Q-Med AB2022-05-27
Surgicel Nu-Knit Absorbable Hemostat (N12159/S092)ETHICON, Inc.2022-05-25
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S099)Integra LifeSciences Corporation2022-05-20
Integra® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S100)Integra Lifesciences Corp.2022-05-20
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RT5, Floseal NT and Floseal Hemostatic Matrix, Floseal (P990009/S069)Baxter Healthcare Corp2022-05-20
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S102)Integra LifeSciences Corporation2022-05-20
SURGICEL® Absorbable Hemostats (SURGICEL® FIBRILLAR™, SURGICEL® SNOW) (N12159/S089)ETHICON, Inc.2022-05-18
Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene (P900033/S098)Integra Lifesciences Corp.2022-05-17
Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler (P090016/S048)Merz North America, Inc.2022-05-05
INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S099)Integra Lifesciences Corp.2022-05-05
RADIESSE® Injectable Implant, including RADIESSE® Hands, RADIESSE® (+) Lidocaine, and RADIESSE® (+) Jawline (P050052/S135)Merz North America, Inc.2022-05-05
RADIESSE® Injectable Implant (P050037/S114)Merz North America, Inc.2022-05-05
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S098)Integra LifeSciences Corporation2022-04-28
Juvéderm Ultra, Ultra XC and Ultra Plus XC, Juvéderm Ultra XC (P050047/S085)Allergan2022-04-28
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S101)Integra LifeSciences Corporation2022-04-28
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC (P110033/S066)Allergan2022-04-28
HEMOBLAST™ Bellows (P170012/S028)Dilon Technologies, Inc.2022-04-22
Helistat and Helitene Absoibable Collagen Hemostatic Agents (P850010/S100)Integra LifeSciences Corporation2022-04-20
Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL) (P160042/S017)Prollenium Medical Technologies, Inc.2022-04-20
MarginProbe System (P110014/S012)Dilon Medical Technologies, Ltd.2022-04-06
SURGIFOAM Absorbable Gelatin Sponge, SURGIFLO® Hemostatic Matrix, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absor (P990004/S054)Ferrosan Meidcal Devices A/S2022-04-06
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01
Avitene Microfibrillar Collagen Hemostat (MCH) Flour, Avitene Microfibrillar Collagen Hemostat (MCH) SyringeAvitene, and (N17600/S034)Davol Inc., Sub. C. R. Bard, Inc.2022-04-01
SURGICEL™ Fibrillar Absorbable Hemostat, SURGICEL SNoW™ Absorbable Hemostat (N12159/S088)ETHICON, Inc.2022-03-15
Floseal Hemostatic Matrix (P990009/S067)Baxter Healthcare Corp2022-03-09
MENTOR MemoryGel Breast Implants (P030053/S065)Mentor Corp.2022-03-08
MENTOR MemoryShape Breast Implants (P060028/S044)Mentor Worldwide, LLC2022-03-08
PHOTOFRIN 630 PDT Laser (P990021/S005)Pinnacle Biologics, Inc.2022-03-02
Sientra OPUS Silicone Gel Breast Implants (P070004/S034)Tiger Aesthetics Medical, LLC2022-03-02
RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S020)Teoxane S.A.2022-02-24
Bellafill Dermal Filler (P020012/S039)Tiger Aesthetics Medical, LLC2022-02-17
Revanesse Versa, Revanesse Versa + (with lidocaine), Revanesse Lips+ (with lidocaine) (P160042/S013)Prollenium Medical Technologies, Inc.2022-02-08
RADIESSE Injectable Implant (P050037/S113)Merz North America, Inc.2022-02-02
RADIESSE Injectable Implant, including RADIESSE Hands, RADIESSE (+) Lidocaine, and RADIESSE (+) Jawline (P050052/S134)Merz North America, Inc.2022-02-02
IDEAL IMPLANT Structured Breast Implant (P120011/S024)Bimini Health Tech2022-01-26
SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S053)Ferrosan Meidcal Devices A/S2022-01-21
SCULPTRA (P030050/S038)Q-Med AB2022-01-21
SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™ , SURGICEL® FIBRILLAR™, SURGICEL® SNOW™) (N12159/S085)ETHICON, Inc.2022-01-21
Bellafill Dermal Filler (P020012/S040)Tiger Aesthetics Medical, LLC2022-01-21
SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat, (N12159/S090)ETHICON, Inc.2022-01-20
SURGIFOAM® Absorbable Gelatin Sponge, SURGIFLO® Hemostatic Matrix, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Abso (P990004/S052)Ferrosan Meidcal Devices A/S2022-01-19
SURGICEL SNoW™ Absorbable Hemostat (N12159/S091)ETHICON, Inc.2022-01-19
RHA® Redensity™ (P170002/S012)Teoxane S.A.2021-12-22
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect (P990004/S051)Ferrosan Meidcal Devices A/S2021-12-21
Restylane-L, Restylane Lyft, Restylane Silk (P040024/S129)Q-Med AB2021-12-14
Perlane, Restylane (P040024/S130)Q-Med AB2021-12-14
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