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General, Plastic Surgery

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

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RecordFirmDate
Juvederm Injectable Gel Implants (P050047/S066)Allergan2019-03-13
Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge (P850010/S082)Integra LifeSciences Corporation2019-03-13
HEMOBLAST Bellows (P170012/S015)Dilon Technologies, Inc.2019-03-13
Restylane Injectable Gels (P040024/S107)Q-Med AB2019-03-07
HEMOBLAST™ Bellows (P170012/S014)Dilon Technologies, Inc.2019-03-05
Floseal Hemostatic Matrix (P990009/S051)Baxter Healthcare Corp2019-03-04
SURGIFLO Hemostatic Matrix Kit w/Thrombin (P990004/S033)Ferrosan Meidcal Devices A/S2019-02-20
Juvederm injectable Gel Implants (P050047/S067)Allergan2019-01-31
Juvederm Injectable Gel Implants (P110033/S041)Allergan2019-01-31
Arista AH; Arista AH Absorbable Hemostat (P050038/S032)Davol, Inc.2019-01-24
HEMOBLAST™ Bellows Laparoscopic Applicator (P170012/S007)Dilon Technologies, Inc.2019-01-18
Nevisense (P150046/S002)Scibase AB2019-01-14
HEMOBLAST™ Bellows (P170012/S013)Dilon Technologies, Inc.2019-01-11
MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S003)Endomagnetics Ltd.,2018-12-28
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (P800002/S024)C.R. Bard, Inc.2018-12-26
Avitene Microfibrillar Collagen Hemostat (N17600/S031)Davol Inc., Sub. C. R. Bard, Inc.2018-12-26
RESTYLANE INJECTABLE GEL (P040024/S105)Q-Med AB2018-12-18
Nevisense (P150046/S003)Scibase AB2018-12-11
SURGICEL Absorbable Hemostats (N12159/S051)ETHICON, Inc.2018-12-07
Integra Dermal Regeneration Template - Terminally Sterilized (P900033/S074)Integra Lifesciences Corp.2018-12-06
HEMOBLAST™ Bellows (P170012/S012)Dilon Technologies, Inc.2018-11-29
SURGICEL Endoscopic Applicator (N12159/S047)ETHICON, Inc.2018-11-21
RESTYLANE REFYNE and RESTYLANE DEFYNE (P140029/S015)Q-Med AB2018-11-19
HEMOBLAST Bellows (P170012/S009)Dilon Technologies, Inc.2018-11-16
SURGICEL Powder (N12159/S049)ETHICON, Inc.2018-11-13
SURGICEL Absorbable Hemostat (N12159/S050)ETHICON, Inc.2018-11-08
Restylane Lyft with Lidocaine Cannula Injection (P040024/S101)Q-Med AB2018-11-02
Belotero Balance Dermal Filler (P090016/S031)Merz North America, Inc.2018-10-23
Restylane Refyne, Restylane Defyne (P140029/S014)Q-Med AB2018-10-17
SURGICEL FIBRILLAR Absorbable Hemostats (N12159/S048)ETHICON, Inc.2018-10-17
HEMOBLAST™ Bellows (P170012/S011)Dilon Technologies, Inc.2018-10-10
HEMOBLAST™ Bellows (P170012/S010)Dilon Technologies, Inc.2018-09-26
Bellafill Dermal Filler (P020012/S018)Tiger Aesthetics Medical, LLC2018-09-25
Restylane Refyne, Restylane Defyne (P140029/S013)Q-Med AB2018-09-20
Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S073)Integra Lifesciences Corp.2018-09-12
Bellafill Dermal Filler (P020012/S014)Tiger Aesthetics Medical, LLC2018-08-28
Bellafill Dermal Filler (P020012/S021)Tiger Aesthetics Medical, LLC2018-08-27
IDEAL IMPLANT Structured Breast Implant (P120011/S013)Bimini Health Tech2018-08-22
Exablate 2100/2100V1 System (P110039/S010)Insightec2018-08-16
RADIESSE 0.8cc and 1.5cc (P050037/S089)Merz North America, Inc.2018-08-12
RADIESSE (+) Lidocaine 0.8cc and 1.5cc (P050052/S105)Merz North America, Inc.2018-08-12
Integra Dermal Regeneration Template (P900033/S072)Integra Lifesciences Corp.2018-08-10
HEMOBLAST™ Bellows (P170012/S008)Dilon Technologies, Inc.2018-08-08
IDEAL IMPLANT Structured Breast Implant (P120011/S012)Bimini Health Tech2018-08-06
Revanesse Versa + (P160042/S003)Prollenium Medical Technologies, Inc.2018-08-02
Restylane Injectable Gels (P040024/S102)Q-Med AB2018-08-02
NATRELLE Saline-Filled Breast Implants (P990074/S042)Allergan2018-08-01
Avitene Microfibrillar Collagen Hemostat (MCH) (N17600/S030)Davol Inc., Sub. C. R. Bard, Inc.2018-08-01
Avitene Microfibrillar Collagen Hemostat (MCH) (P800002/S023)C.R. Bard, Inc.2018-08-01
NATRELLE Silicone-Filled Breast Implants (P020056/S048)Allergan2018-08-01
NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled (P040046/S029)Allergan2018-08-01
Bellafill Dermal Filler (P020012/S026)Tiger Aesthetics Medical, LLC2018-07-26
Belotero Balance Dermal Filler (P090016/S030)Merz North America, Inc.2018-07-25
Restylane Refyne, Restylane Defyne (P140029/S007)Q-Med AB2018-07-25
MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053)Endomagnetics Ltd.,2018-07-24
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S071)Integra Lifesciences Corp.2018-07-19
HEMOBLAST™ Bellows (P170012/S006)Dilon Technologies, Inc.2018-07-16
Nevisense (P150046/S001)Scibase AB2018-07-13
HEMOBLAST™ Bellows (P170012/S005)Dilon Technologies, Inc.2018-07-11
Radiesse (P050037/S093)Merz North America, Inc.2018-07-06
Radiesse (+) Lidocaine Dermal Filter (P050052/S106)Merz North America, Inc.2018-07-06
Radiesse (+) (P050052/S109)Merz North America, Inc.2018-07-06
Radiesse Injectable Implant (P050037/S090)Merz North America, Inc.2018-07-06
Radiesse Injectable Implant (P050037/S092)Merz North America, Inc.2018-07-05
Radiesse Hands, Radiesse (+) Lidocaine Dermal Filler (P050052/S108)Merz North America, Inc.2018-07-05
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S079)Integra LifeSciences Corporation2018-06-28
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S078)Integra LifeSciences Corporation2018-06-28
RESTYLANE REFYNE and RESTYLANE DEFYNE (P140029/S012)Q-Med AB2018-06-28
Ideal Implant Structured Breast Implant (P120011/S011)Bimini Health Tech2018-06-28
NATRELLE Silicon-Filled Breast Implants (P020056/S046)Allergan2018-06-27
NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S027)Allergan2018-06-27
Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S047)Mentor Corp.2018-06-26
Mentor MemoryShape Breast Implants (P060028/S029)Mentor Worldwide, LLC2018-06-26
Mentor Saline-Filled and SPECTRUM Breast Implants (P990075/S044)Mentor Worldwide, LLC2018-06-26
Restylane Refyne, Restylane Defyne (P140029/S010)Q-Med AB2018-06-22
RESTYLANE REYNE and RESTYLANE DEFYNE INJECFTABLE GELS (P140029/S011)Q-Med AB2018-06-21
HEMOBLAST™ Bellows (P170012/S004)Dilon Technologies, Inc.2018-06-14
Restylane Refyne, Restylane Defyne (P140029/S009)Q-Med AB2018-06-14
Restylane Refyne and Restylane Defyne Injectable Gels (P140029/S008)Q-Med AB2018-06-13
Sculptra and Sculptra Aesthetic (P030050/S029)Q-Med AB2018-05-23
Optiguide Fiber Optic Diffuser (P940010/S015)Pinnacle Biologics, Inc.2018-05-18
Restylane Lyft with Lidocaine (P040024/S099)Q-Med AB2018-05-18
Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S082)Integra LifeSciences Corporation2018-05-17
Helistat, Helitene Absorbable Collagen Hemostatic Agents (P850010/S081)Integra LifeSciences Corporation2018-05-17
Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regeneration Matr (P900033/S070)Integra Lifesciences Corp.2018-05-17
Restylane Refyne, Restylane Defyne Injectable Gels (P140029/S006)Q-Med AB2018-05-11
HEMOBLAST™ Bellows (P170012/S003)Dilon Technologies, Inc.2018-05-10
Voluma XC, Vollure XC, Volbella XC (P110033/S039)Allergan2018-05-04
Juvederm Ultra, Ultra XC, Ultra Plus, Ultra Plus XC (P050047/S065)Allergan2018-05-04
HEMOBLAST™ Bellows (P170012/S001)Dilon Technologies, Inc.2018-05-02
Juvederm Voluma XC, Vollure XC, and Juvederm Volbella XC (P110033/S038)Allergan2018-05-01
SCULPTRA Aesthetic (injectable poly-L Lactic acid) (P030050/S028)Q-Med AB2018-05-01
Juvederm Ultra, Ultra XC, Ultra Plus, and Juvederm Ultra Plus XC (P050047/S064)Allergan2018-05-01
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template Intergra, Ominigraft Dermal Regenerati (P900033/S069)Integra Lifesciences Corp.2018-04-25
Hilistat, Helitene, Absorbable Collagen Hemostatic Agents (P850010/S080)Integra LifeSciences Corporation2018-04-25
Collastat, Absorable Collagen, Hemostatic Sponge Collastat, Absorbable Collagen Hemostatic Agent, Microfibrillar Form (P810006/S081)Integra LifeSciences Corporation2018-04-25
RADIESSE (+) Lidocaine Dermal Filler 1.5CC (P050052/S104)Merz North America, Inc.2018-04-24
RADIESSE Injectable Implant 1.5CC (P050037/S088)Merz North America, Inc.2018-04-24
Bellafill Dermal Filler (P020012/S025)Tiger Aesthetics Medical, LLC2018-04-23
Sientra OPUS Silicone Gel Breast Implants (P070004/S013)Tiger Aesthetics Medical, LLC2018-04-17
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