Atlas FDA

General, Plastic Surgery

16,262 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PicoWay Laser System (K191685)Candela Corporation2019-09-16
NICO Myriad NOVUS (K191599)Nico Corporation2019-09-13
RFID Localization System (K190932)Health Beacons, Inc.2019-09-13
CO2 Laser System (K191518)Shenzhen Gsd Tech Co., Ltd.2019-09-12
faceLITE (K191629)Ismart Marketing Svcs, Ltd.2019-09-12
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (K191355)3M Healthcare2019-09-11
Sterling Supreme Diode Laser (K181614)CAO Group, Inc.2019-09-10
BH Medical Dental Barrier Sleeves and Barrier Film (K190484)Bh Medical Products Co., Ltd.2019-09-10
Pioneer Elite Diode Laser (K181602)CAO Group, Inc.2019-09-10
Precise SHP Diode Laser (K181601)CAO Group, Inc.2019-09-09
Sofacia System (K191421)Sofwave Medical, Ltd.2019-09-09
Secret RF Smartcure Applicator with electrodes (K182355)Ilooda Co,., Ltd.2019-09-06
Gem FlowCoupler System (K190499)Baxter/ Synovis Micro Companies Alliance, Inc.2019-09-06
EVO Platform (K192160)Quanta System Spa2019-09-06
Venus Legacy Pro Device (K191528)Venus Concept USA, Inc.2019-09-06
Holinwon 30 (K183563)Wontech Co., Ltd.2019-09-05
GOLNIT Non-aborbable PTFE Surgical Suture (K192088)Antarma, LLC Dba Golnit Sutures2019-09-04
Signia Small Diameter Reloads (K191070)Covidien2019-09-04
Sutter RaVoR Bipolar Electrodes (K191732)Sutter Medizintechnik GmbH2019-08-30
LightWalker Laser System Family (K191554)Fotona D.O.O.2019-08-30
EvaQMax Smoke Evacuation System (K192035)Bio Protech, Inc.2019-08-29
810nm Diode Laser System (K183122)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2019-08-25
Customized Contour Implant (K191130)Implantech Associates, Inc.2019-08-23
Acare Suction Unit (K182950)Acare Technology Co., Ltd.2019-08-23
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (K191413)AtriCure, Inc.2019-08-21
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K183536)Hartalega NGC Sdn. Bhd.2019-08-16
980nm Diode Laser Therapy Device (K191349)Shanghai Apolo Medical Technology Co., Ltd.2019-08-16
Stryker CMF MEDPOR Priority Customized Implant Kit (K191916)Stryker Leibinger GmbH & Co KG2019-08-15
Viola (K190264)Meditime Co., Ltd.2019-08-15
SignalMark Breast Marker (K190689)View Point Medical, Inc.2019-08-14
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (K183647)Olympus Surgical Technologies America2019-08-09
Primelase Excellence (K191321)High Technology Products S.L.U2019-08-02
DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) (K183112)Lumendi, LLC2019-08-02
Fluobeam LX (K190891)Fluoptics2019-07-31
GORE BIO-A Tissue Reinforcement (K191773)W. L. Gore & Associates, Inc.2019-07-31
DemeTECH DemeFORCE Nonabsorbable Surgical Suture (K190777)Demetech Corporation2019-07-31
Diode Laser Therapy Systems (K191611)Wingderm Electro-Optics , Ltd.2019-07-31
Renuvion/J-Plasma Precise Handpiece (K191484)Apyx Medical Corporation(Formerly Bovie Medical Corporation)2019-07-30
Megadyne Foot Switch (K191328)Megadyne Medical Products, Inc.2019-07-26
ScanX Barrier Envelopes (K190949)Air Techniques, Inc.2019-07-26
The ZIP Accessory Shuttle for PleuraFlow System (K191733)Clearflow, Inc.2019-07-26
TempSure (K190678)Cynosure, Inc.2019-07-24
Coolrail Linear Pen (K190587)AtriCure, Inc.2019-07-24
Exceed Microneedling device (K182407)Mt. Derm GmbH2019-07-19
Powersculp laser lipolysis system (K191068)Wuhan Lotuxs Technology Co., Ltd.2019-07-17
Biotex (K180992)Purgo Biologics, Inc.2019-07-16
OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners (K191287)Davol Inc., Subsidiary of C.R. Bard2019-07-16
Valleylab FT10 Electrosurgical Platform (K191601)Covidien2019-07-12
StitchKit (K191317)Origami Surgical2019-07-12
PerioLase Nd:YAG Pulsed Dental Laser System (K182930)Millennium Dental Technologies, Inc.2019-07-12
AeroForm Tissue Expander, Smooth (K191138)Airxpanders, Inc.2019-07-11
Gem FlowCoupler System (K191252)Baxter/ Synovis Micro Companies Alliance, Inc.2019-07-09
EpiLaze Multi-wavelength Laser (K191162)Rohrer Aesthetics, LLC2019-07-09
Microwave Ablation System (K183153)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2019-07-08
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) (K190950)Medline Industries, Inc.2019-07-04
PWD Platform Wound Dressing 3” x 5” Oblong (K191460)Applied Tissue Technologies, LLC2019-07-02
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove (K183389)Hartalega NGC Sdn. Bhd.2019-06-28
FlexGard Cut-Resistant Glove Liners (K190782)Ldi Corporation2019-06-27
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture (K183183)ETHICON, Inc.2019-06-27
DigniCap Delta (K191166)Dignitana, Inc.2019-06-26
Phototherapy System (K190938)Shanghai Apolo Medical Technology Co., Ltd.2019-06-26
Radio Frequency Ablation System (K190052)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2019-06-25
Venus Bliss (K190743)Venus Concept USA, Inc.2019-06-25
MMSphere (K190443)Galactic Beauty, LLC2019-06-24
Soniquence Bipolar Electrodes (K190336)Soniquence, LLC2019-06-20
EmBody System (K183450)Inmode MD , Ltd.2019-06-20
STOP U (Packed Black USA), STOP U (Packed White USA) (K182774)Pollogen, Ltd.2019-06-19
NanoKnife System (K183385)Angiodynamics2019-06-18
Bovine Pericardial Tissue Patch (K182493)Tisgenx2019-06-18
Q-Switched Nd: YAG Laser System (K190936)Shanghai Apolo Medical Technology Co., Ltd.2019-06-17
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope (K183263)Unipack Medical Corporation2019-06-14
Silhouette Featherlift / Silhouette Lift (K191299)Silhouette Lift, Inc.2019-06-14
CLARITY II Laser System (K183566)Lutronic Corporation2019-06-14
Electrosurgical Generator (K183564)Fulwell, LLC2019-06-13
Viveve System 2.0 (K190422)Viveve Medical2019-06-12
Eon FR (K180511)Dominion Aesthetic Technologies, Inc.2019-06-12
Argon Handset (K191064)New Deantronics Taiwan , Ltd.2019-06-12
Phasix ST Mesh with Open Positioning System (K190185)C.R. Bard, Inc.2019-06-12
Force Fiber Suture (K191268)Teleflex Medical Incorporated2019-06-11
PDS Barbed Suture, PDO MAXX Threads (K190245)Pdo Max, Inc.2019-06-04
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (K190194)Pentax Medical, A Division of Pentax of America, Inc.2019-05-31
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device (K190623)Medtronic2019-05-30
Segmented Esophageal Stent System (K182910)Micro-Tech (Nanjing) Co., Ltd.2019-05-29
Surgical Face Mask (K182515)Wuhan Dymex Healthcare Co., Ltd.2019-05-27
Soliton Acoustic Wave Device (K190542)Soliton, Inc.2019-05-24
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove (K190077)Molnlycke Health Care Us, LLC2019-05-24
Longterm NPWT Foam Dressing Kit (K182458)Zhejiang Longterm Medical Technology Co., Ltd.2019-05-23
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (K190018)Ansell Healthcare Products, LLC2019-05-23
Erbe ESU Model VIO 3 with Accessories (K190823)Erbe Elektromedizin GmbH2019-05-22
Soniquence RF Generator and Soniquence Electrodes (K183611)Soniquence, LLC2019-05-22
REMY Medical Therapy Laser System (K190034)Footdocprenur, LLC2019-05-15
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound (K190173)Jk-Holding GmbH2019-05-10
SteriStay (K190027)Toul Meditech AB2019-05-10
Electrosurgical accessory (K183126)New Deantronics Taiwan , Ltd.2019-05-08
Medline Electrocautery Pencil (K190643)Medline Industries, Inc.2019-05-06
AuraGen 123 Suction Lipoplasty System (A123) (K190278)Auragen Aesthetics, LLC2019-05-03
TRIO Handpiece (K183199)Omniguide, Inc.2019-05-02
HS Fiber (K190817)Riverpoint Medical2019-05-01
PowerX Lipo System (K190555)Solta Medical2019-05-01
VASERlipo System (K190551)Solta Medical2019-05-01
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