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General, Plastic Surgery

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

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RecordFirmDate
RHA® Redensity™ (P170002/S032)Teoxane S.A.2023-08-31
Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S077)Allergan2023-08-30
Ultra, Ultra XC, Ultra Plus XC, Ultra XC (P050047/S090)Allergan2023-08-30
Saline-Filled and Spectrum Breast Implants (P990075/S053)Mentor Worldwide, LLC2023-08-23
Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S (P900033/S108)Integra Lifesciences Corp.2023-08-21
Arista AH (P050038/S040)Davol, Inc.2023-08-09
Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028/S049)Mentor Worldwide, LLC2023-08-08
Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S070)Mentor Corp.2023-08-08
SKINVIVE™ by Juvederm (P110033/S072)Allergan2023-08-01
Silicone Gel Breast Implants (P070004/S027)Tiger Aesthetics Medical, LLC2023-07-31
Juvéderm Injectable Gel Implant (P050047/S089)Allergan2023-07-28
LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024/S001)Advanced Medical Solutions Limited2023-07-28
Radiesse Injectable Implant, Radiesse Hands, Radiesse (+) Lidocaine, Radiesse (+) Jawline (P050052/S150)Merz North America, Inc.2023-07-12
Natrelle Silicone-Filled Breast Implants (P020056/S061)Allergan2023-07-12
Radiesse® Injectable Implant (P050037/S128)Merz North America, Inc.2023-07-12
SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT™ Absorbable Hemostat, SURGICEL® SNOW™ Absorbable Hemostat (N12159/S104)ETHICON, Inc.2023-07-11
Sculptra and Sculptra Aesthetic (P030050/S042)Q-Med AB2023-07-11
Skinvive™ by Juvéderm® (P110033/S076)Allergan2023-07-06
RHA® Redensity, RHA®2, RHA®3 and RHA® Dermal Fillers (P170002/S023)Teoxane S.A.2023-07-05
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Oral Sponge, Hemorrhoidectomy Sponge (P990004/S060)Ferrosan Meidcal Devices A/S2023-06-29
Magtrace® and Sentimag® Magnetic Locatization System (PUV) (P160053/S007)Endomagnetics Ltd.,2023-06-29
SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S059)Ferrosan Meidcal Devices A/S2023-06-29
Skinvive™ by Juvéderm (P110033/S074)Allergan2023-06-29
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S149)Merz North America, Inc.2023-06-28
RADIESSE® Injectable Implant (P050037/S127)Merz North America, Inc.2023-06-28
SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™) (N12159/S103)ETHICON, Inc.2023-06-26
Skinvive™ by Juvéderm® (P110033/S073)Allergan2023-06-23
MemoryGel® BOOST™ Silicone Gel-Filled Breast Implant (P030053/S068)Mentor Corp.2023-06-21
Bellafill Dermal Filler (P020012/S045)Tiger Aesthetics Medical, LLC2023-06-15
Sculptra and Sculptra Aesthetic (P030050/S043)Q-Med AB2023-06-14
SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SURGIFLO® Hemostatic Matrix, SURGIFLO® H (P990004/S058)Ferrosan Meidcal Devices A/S2023-06-14
Belotero Balance® Dermal Filler, Belotero Balance® (+) Lidocaine Dermal Filler (P090016/S054)Merz North America, Inc.2023-06-12
RHA® Redensity™, RHA®2, RHA®3, RHA®4 (P170002/S031)Teoxane S.A.2023-06-12
Juvéderm® Hyaluronate Gel Implants (P050047/S088)Allergan2023-06-08
Radiesse® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Lidocaine Jawline (P050052/S148)Merz North America, Inc.2023-06-08
Radiesse® Injectable Implant (P050037/S126)Merz North America, Inc.2023-06-08
Juvéderm® Hyaluronate Gel Implants (P110033/S071)Allergan2023-06-08
Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template Sterilized (P900033/S107)Integra Lifesciences Corp.2023-06-07
Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain (P160042/S022)Prollenium Medical Technologies, Inc.2023-06-06
LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024)Advanced Medical Solutions Limited2023-06-02
Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants (P990075/S058)Mentor Worldwide, LLC2023-06-02
Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants (P990075/S057)Mentor Worldwide, LLC2023-06-02
Sculptra (P030050/S040)Q-Med AB2023-06-02
Restylane® Injectable Gels (P140029/S049)Q-Med AB2023-06-01
Restylane® Injectable Gels (P040024/S137)Q-Med AB2023-06-01
Restylane Eyelight (P040024/S138)Q-Med AB2023-05-30
Sientra OPUS Silicone Gel Breast Implants (P070004/S018)Tiger Aesthetics Medical, LLC2023-05-26
Sientra OPUS Silicone Gel Breast Implants (P070004/S017)Tiger Aesthetics Medical, LLC2023-05-26
Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants (P990075/S056)Mentor Worldwide, LLC2023-05-24
Mentor MemoryShape Breast Implants (P060028/S048)Mentor Worldwide, LLC2023-05-24
FlexiTip XL-R Applicator (P050038/S041)Davol, Inc.2023-05-24
Bellafill Dermal Filler (P020012/S044)Tiger Aesthetics Medical, LLC2023-05-19
PerClot® Polysaccharide Hemostatic System (P210036)Baxter Healthcare Corporation2023-05-19
Belotero Balance Dermal Filler, Belotero Balance(+) Lidocaine Dermal Filler (P090016/S053)Merz North America, Inc.2023-05-18
GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041)Pfizer, Inc.2023-05-16
RHA 2, RHA 3, RHA 4 (P170002/S022)Teoxane S.A.2023-05-12
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S107)Integra LifeSciences Corporation2023-05-11
Skinvive by Juvéderm (P110033/S059)Allergan2023-05-11
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S104)Integra LifeSciences Corporation2023-05-11
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S105)Integra LifeSciences Corporation2023-05-10
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S108)Integra LifeSciences Corporation2023-05-10
Restylane® Eyelight (P040024/S135)Q-Med AB2023-05-08
RADIESSE® Injectable Implant (P050037/S124)Merz North America, Inc.2023-05-04
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® Jawline (P050052/S146)Merz North America, Inc.2023-05-04
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC (P110033/S069)Allergan2023-05-03
Juvéderm Ultra, Ultra XC, and Ultra Plus XC, Juvéderm Ultra XC (P050047/S087)Allergan2023-05-03
RHA® Redensity™, RHA®2, RHA®3, RHA®4 Dermal Fillers (P170002/S027)Teoxane S.A.2023-04-27
RHA® Redensity™, RHA®2, RHA®3, RHA®4 Dermal Fillers (P170002/S028)Teoxane S.A.2023-04-27
RHA®2 (P170002/S024)Teoxane S.A.2023-04-26
RADIESSE® Injectable Implant (P050037/S123)Merz North America, Inc.2023-04-26
SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S057)Ferrosan Meidcal Devices A/S2023-04-26
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S145)Merz North America, Inc.2023-04-26
Sculptra (P030050/S039)Q-Med AB2023-04-25
Avitene™ Microfibrillar Collagen Hemostat (N17600/S038)Davol Inc., Sub. C. R. Bard, Inc.2023-04-25
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S106)Integra LifeSciences Corporation2023-04-18
INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S106)Integra Lifesciences Corp.2023-04-18
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S103)Integra LifeSciences Corporation2023-04-18
RHA® Redensity™, RHA®2, RHA®3 and RHA®4 dermal fillers (P170002/S029)Teoxane S.A.2023-04-14
Restylane Kysse (P140029/S048)Q-Med AB2023-04-12
SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™) (N12159/S101)ETHICON, Inc.2023-04-04
Belotero Balance Dermal Filler (P090016/S052)Merz North America, Inc.2023-03-31
Revanesse Versa, Revanesse Versa+ with Lidocaine, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.2 mL, Revane (P160042/S020)Prollenium Medical Technologies, Inc.2023-03-22
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, Juvéderm Ultra Plus XC (P050047/S083)Allergan2023-03-16
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvederm Volbella XC (P110033/S063)Allergan2023-03-16
Juvéderm® Volux™ XC (P110033/S068)Allergan2023-02-28
SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™, SURGICEL® POWDER™) (N12159/S100)ETHICON, Inc.2023-02-28
Collastat/INSTAT Absorbable Collagen Hemostatic Agent (P810006/S102)Integra LifeSciences Corporation2023-02-23
Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S (P900033/S105)Integra Lifesciences Corp.2023-02-23
Helistat/Helitene Absorbable Collagen Hemostatic Agent (P850010/S105)Integra LifeSciences Corporation2023-02-23
SURGICEL® SNOW™ Absorbable Hemostat (N12159/S099)ETHICON, Inc.2023-02-16
SURGICEL Absorbable Hemostats, SURGICEL Powder (N12159/S098)ETHICON, Inc.2023-02-16
Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.0 mL, Revanesse Versa+ with Lidocaine (P160042/S018)Prollenium Medical Technologies, Inc.2023-02-15
Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S104)Integra Lifesciences Corp.2023-02-07
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02
IDEAL IMPLANT® Structured Breast Implant (P120011/S023)Bimini Health Tech2023-02-01
SURGIFOAM® Absorbable Gelatin Sponge, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SU (P990004/S056)Ferrosan Meidcal Devices A/S2023-01-31
RHA® Redensity™, RHA ®2, RHA ®3, RHA ®4 dermal fillers (P170002/S025)Teoxane S.A.2023-01-26
RADIESSE® Injectable Implant (P050037/S116)Merz North America, Inc.2023-01-24
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S137)Merz North America, Inc.2023-01-24
RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S142)Merz North America, Inc.2023-01-12
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