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General, Plastic Surgery

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

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RecordFirmDate
Juvederm Voluma XC (P110033/S042)Allergan2019-08-29
Belotero Balance (+) Lidocaine (P090016/S028)Merz North America, Inc.2019-08-29
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S085)Integra Lifesciences Corp.2019-08-28
Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S083)Integra Lifesciences Corp.2019-08-28
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S084)Integra Lifesciences Corp.2019-08-28
Juvederm Injectable Gel Implants (Voluma XC, Vollure XC and Volbella XC) (P110033/S048)Allergan2019-08-27
Juvederm Injectable Gel Implants (Ultra, Ultra XC and Ultra Plus XC) (P050047/S072)Allergan2019-08-27
SURGICEL Nu-Knit Absorbable Hemostat (N12159/S062)ETHICON, Inc.2019-08-14
Surgicel Powder Absorbable Hemostatic Powder (N12159/S057)ETHICON, Inc.2019-08-14
Restylane Refyne, Restylane Defyne (P140029/S017)Q-Med AB2019-08-13
INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Interga Omnigraft Dermal Regenerat (P900033/S082)Integra Lifesciences Corp.2019-08-08
SURGICEL BRAND ABSORBABLE HEMOSTAT (N12159/S061)ETHICON, Inc.2019-08-02
Surgical Absorbable Hemostats (N12159/S060)ETHICON, Inc.2019-08-02
Belotero Balance (P090016/S033)Merz North America, Inc.2019-07-31
PERLANE (P040024/S108)Q-Med AB2019-07-31
Floseal hemostatic Matrix (P990009/S056)Baxter Healthcare Corp2019-07-26
SURGIFOAM, Absorbable Gelatin Sponge U.S.P. (P990004/S034)Ferrosan Meidcal Devices A/S2019-07-24
Revanesse Versa (P160042/S007)Prollenium Medical Technologies, Inc.2019-07-24
Spectrum Saline-Filled Breast Implants (P990075/S045)Mentor Worldwide, LLC2019-07-24
SURGICEL Absorbable Hemostats (N12159/S059)ETHICON, Inc.2019-07-23
Floseal Hemostatic Matrix (P990009/S057)Baxter Healthcare Corp2019-07-19
IDEAL IMPLANT Structured Breast Implant (P120011/S016)Bimini Health Tech2019-07-19
SURGIFOAM Absorbable Gelatin Sponge (P990004/S035)Ferrosan Meidcal Devices A/S2019-07-17
Integra Meshed Dermal Regeneration Template (P900033/S081)Integra Lifesciences Corp.2019-07-15
MemoryGel Silicone Gel-Filled Breast Implants (P030053/S052)Mentor Corp.2019-07-12
SURGICEL Powder Absorbable Hemostatic Powder (N12159/S058)ETHICON, Inc.2019-07-11
ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER (P020012/S030)Tiger Aesthetics Medical, LLC2019-07-11
Bellafill Dermal Filler (P020012/S031)Tiger Aesthetics Medical, LLC2019-07-08
Juvederm Injectable Gel Implants (P110033/S044)Allergan2019-07-03
Juvederm Injectable Gel Implants (P050047/S069)Allergan2019-07-03
Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge (N18286/S032)Pfizer, Inc.2019-07-02
Restylane and Perlane (P040024/S104)Q-Med AB2019-06-28
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants (P040046/S030)Allergan2019-06-27
Natrelle Silicone Filled Breast Implants (P020056/S049)Allergan2019-06-27
Helistat, Helitene Absorbable Collagen Hemaostatic Agents (P850010/S089)Integra LifeSciences Corporation2019-06-27
Collastat Absorbable Collagen Hemostatic Sponge Collastat Absorbable Collagen Hemostatic-Microfibrillar Form (INSTAT) (P810006/S089)Integra LifeSciences Corporation2019-06-27
Juvederm Injectable Gel Implants (P050047/S071)Allergan2019-06-26
Bellafill Dermal Filler (P020012/S020)Tiger Aesthetics Medical, LLC2019-06-26
Juvederm Injectable Gel Implants (P110033/S046)Allergan2019-06-26
Avitene Microfibrillar Collagen Hemostat (MCH) Flour, SyringeAvitene and UltraFoam (N17600/S032)Davol Inc., Sub. C. R. Bard, Inc.2019-06-21
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene (P800002/S025)C.R. Bard, Inc.2019-06-21
RESTYLANE NASHA (P040024/S113)Q-Med AB2019-06-20
Restylane Injectable Gels (P040024/S111)Q-Med AB2019-06-19
MarginProbe System (P110014/S008)Dilon Medical Technologies, Ltd.2019-06-19
Belotero Balance (P090016/S032)Merz North America, Inc.2019-06-18
HEMOBLAST™ Bellows (P170012/S018)Dilon Technologies, Inc.2019-06-15
Collastat Absorbable Collagen Hemostatic Sponge (P810006/S083)Integra LifeSciences Corporation2019-06-14
Helistat Absorbable Collagen Hemostatic Agent (P850010/S083)Integra LifeSciences Corporation2019-06-14
Bellafill Derma Filler (P020012/S027)Tiger Aesthetics Medical, LLC2019-06-10
Radiesse (+) Lidocaine Dermal Filler (P050052/S113)Merz North America, Inc.2019-06-07
Radiesse Injectable Implant (P050037/S097)Merz North America, Inc.2019-06-07
Radiesse Injectable Implany and Radiesse (+) Lidocaine Dermal Filler (P050052/S114)Merz North America, Inc.2019-06-07
Radiesse Injectable Implant (P050037/S096)Merz North America, Inc.2019-06-07
Radiesse 1.5cc and 0.8cc (P050037/S095)Merz North America, Inc.2019-06-06
Restylane-L (P040024/S106)Q-Med AB2019-06-06
Radiesse (+) Lidocaine Dermal Filler (1.5cc and 0.8cc) (P050052/S112)Merz North America, Inc.2019-06-06
Revanesse Versa and Revanesse Versa+ (P160042/S009)Prollenium Medical Technologies, Inc.2019-06-04
SURGICEL SNoW Absorbable Hemostat (N12159/S053)ETHICON, Inc.2019-05-23
Hemoblast Bellows (P170012/S017)Dilon Technologies, Inc.2019-05-21
SURGICEL Absorbable Hemostats (N12159/S056)ETHICON, Inc.2019-05-17
Radiesse Injectable Implant (P050037/S094)Merz North America, Inc.2019-05-17
Radiessse Hands, and Radiesse (+) Lidocaine Dermal Filler (P050052/S111)Merz North America, Inc.2019-05-17
RESTYLANE (P040024/S103)Q-Med AB2019-05-17
SURGICEL Absorbable Hemostats (N12159/S055)ETHICON, Inc.2019-05-15
HEMOBLAST Bellows (P170012/S016)Dilon Technologies, Inc.2019-05-15
Floseal Hemostatic Matrix (P990009/S054)Baxter Healthcare Corp2019-05-15
Restylane and Perlane (P040024/S110)Q-Med AB2019-05-15
Juvéderm Injectable Gel Implants (P050047/S070)Allergan2019-05-10
Juvéderm Injectable Gel Implants (P110033/S045)Allergan2019-05-10
OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series) (P940010/S016)Pinnacle Biologics, Inc.2019-05-09
MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S001)Endomagnetics Ltd.,2019-05-08
Collastat Absorbable Collagen Hemostatic Sponge and Collstat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S087)Integra LifeSciences Corporation2019-05-07
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S088)Integra LifeSciences Corporation2019-05-07
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S080)Integra Lifesciences Corp.2019-05-07
Integra Dermal Regeneration Template, Intergra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regener (P900033/S079)Integra Lifesciences Corp.2019-05-07
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S087)Integra LifeSciences Corporation2019-05-07
Helistat and Helitene Absorbabale Collagen Hemostatic Agents (P850010/S088)Integra LifeSciences Corporation2019-05-07
Radiesse Injectable Implant (P050052/S110)Merz North America, Inc.2019-05-03
Bellafill Dermal Filler (P020012/S029)Tiger Aesthetics Medical, LLC2019-05-03
Helistat and Helitene Absorbable Collagen Hemostatic Agent (P850010/S086)Integra LifeSciences Corporation2019-04-26
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form (P810006/S086)Integra LifeSciences Corporation2019-04-26
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S078)Integra Lifesciences Corp.2019-04-26
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S077)Integra Lifesciences Corp.2019-04-19
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic- Microfibrillar Form (P810006/S085)Integra LifeSciences Corporation2019-04-19
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S085)Integra LifeSciences Corporation2019-04-19
Floseal NT (P990009/S053)Baxter Healthcare Corp2019-04-18
Sientra OPUS Silicone Gel Breast Implants (P070004/S015)Tiger Aesthetics Medical, LLC2019-04-17
SURGICEL Absorbable Hemostats (N12159/S054)ETHICON, Inc.2019-04-12
RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S003)Teoxane S.A.2019-04-10
Bellafill Dermal Filler (P020012/S028)Tiger Aesthetics Medical, LLC2019-04-05
Juvederm Ultra XC and Ultra Plus XC (P050047/S068)Allergan2019-04-04
Juvederm Voluma XC, Vollure XC and Volbella XC (P110033/S043)Allergan2019-04-04
RHA 2, RHA 3, and RHA 4 dermal fillers (P170002/S002)Teoxane S.A.2019-03-22
FLOSEAL Hemostatic Matrix (P990009/S052)Baxter Healthcare Corp2019-03-22
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S076)Integra Lifesciences Corp.2019-03-15
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent- Microfibrillar Form (P810006/S084)Integra LifeSciences Corporation2019-03-15
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form (P850010/S084)Integra LifeSciences Corporation2019-03-15
Revanesse Versa, Revanesse Versa + (P160042/S004)Prollenium Medical Technologies, Inc.2019-03-15
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S075)Integra Lifesciences Corp.2019-03-15
RESTYLANE Refyne and RESTYLANE Defyne (P140029/S016)Q-Med AB2019-03-15
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