Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
Basic, Dominant Flex (K170329)Modela AG2017-03-24
PerfectSmooth (K161428)Shen Zhen Cosbeauty Co., Ltd.2017-03-23
Tranberg CLS Diffusor Laser Fiber (K163103)Clinical Laserthermia Systems, AB2017-03-23
CoreCath 2.7S (K170296)Medtronic Advanced Energy2017-03-20
Sparkling (K163655)Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd2017-03-17
Thermi Injectable RF Electrodes (K170116)Thermi2017-03-13
PROLENE Soft Polypropylene Mesh (K163152)ETHICON, Inc.2017-03-11
FLEX Microwave Ablation System and Accessories (K163118)Neuwave Medical, Inc.2017-03-09
VIVA combo RF System (K163450)Starmed Co., Ltd.2017-03-08
Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator (K170188)Bovie Medical Corporation2017-03-08
iPulse SmoothSkin BARE Hair Removal Device (K163552)Cyden Limited2017-03-03
Cyber Ho (K170331)Quanta System Spa2017-03-03
Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler (K162947)Chongqing Qmi Surgical Co., Ltd.2017-03-03
Slimming Treatment Device (K161892)Beijing Honkon Technologies Co., Ltd.2017-03-02
Signia Four-Bay Smart Charger (to be used with Signia Stapler) (K170348)Covidien2017-03-02
REXLON, REXSIL (K161633)Sm Eng Co., Ltd.2017-03-02
RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed (K161737)Myco Medical2017-03-02
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System (K162837)Lumenis, Ltd.2017-02-28
Jac-Cell Medic testers (K170105)Jac-Cell Medic2017-02-28
ComfortGuard Surgical Gown, i600, Film Reinforced (K163191)Gri Medical & Electrical Technology Co., Ltd.2017-02-27
The Red Head Collection Device, The Jordy Connection System (K161372)Miami Fat Supply2017-02-24
ARTIA Reconstructive Tissue Matrix Perforated (K162752)Lifecell Corporation2017-02-24
GalaFORM 3D (K162922)Tepha, Inc.2017-02-23
ND YAG Q-switch Laser Therapy Machine (K161926)Beijing Adss Development Co., Ltd.2017-02-22
ExpressBraid Graft Manipulation (K163651)Biomet Manufacturing Corp2017-02-17
T-Cuff (K162365)Terumobct, Inc.2017-02-16
Valleylab FT10 Electrosurgical Platform (K170170)Covidien, LLC2017-02-16
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction (K162965)Tei Biosciences, Inc.2017-02-16
Miromatrix Biological Mesh TW (K162570)Miromatrix Medical, Inc.2017-02-16
ENSEAL X1 Large Jaw Tissue Sealer (K163548)Ethicon Endo-Surgery, LLC2017-02-14
ClariFix Device (K162608)Arrinex, Inc.2017-02-14
GORE BIO-A Tissue Reinforcement (K163217)W. L. Gore & Associates, Inc.2017-02-10
CRYLREX (K161629)Sm Eng Co., Ltd.2017-02-10
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload (K162710)Tgs Medical Co., Ltd.2017-02-09
MyNeWT Negative Pressure Wound Therapy System (K161432)Stortford Medical, LLC2017-02-08
Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove (K162852)Lucenxia Prescience AG2017-02-08
Handheld Diode Laser for Hair Removal (K163173)Liaoning Sidey Optoelectronics Technologies Co., Ltd.2017-02-08
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) (K162388)Curaseal, Inc.2017-02-03
Q-Switched Nd:YAG Laser Therapy Systems (K163123)Beijing Sincoheren Science and Technology Development Co.2017-02-02
PicoWay Laser System (K162454)Syneron Candela Corporation2017-02-01
Medline Non-Surgical Isolation Gown- (K160471)Medline Industries, Inc.2017-01-31
OsteoCool V-3 RF Ablation System (K161949)Baylis Medical Company, Inc.2017-01-31
OBS Electrosurgical Generator (Model: OBS-350A) (K162034)Baisheng Medical Co., Ltd.2017-01-30
LED Phototherapy Device (K162098)Li-Tek Electronic Technology Corporation2017-01-30
V.A.C.ULTA Negative Pressure Wound Therapy System (K162790)Kci USA, Inc. (Kinetic Concepts, Inc.)2017-01-26
eLyx-PRO (K162851)Intelligent Sensory Concept SA2017-01-24
Barrx Anorectal RFA Wand (K162802)Covidien, LLC2017-01-24
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823)Wrp Asia Pacific Sdn. Bhd.2017-01-23
Ranfac Fat Aspiration Cannula (K162932)Ranfac, Corp.2017-01-19
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set (K161418)Cardinalhealth2017-01-19
RED Light Device (K162489)Zhongshan Bisen Plastic Electronic Products Co., Ltd.2017-01-13
Magseed Magnetic Marker System (K163541)Endomagnetics Ltd.,2017-01-13
Exilis XP II (K163176)BTL Industries, Inc.2017-01-12
Venus Velocity Diode Laser System (K162765)Venus Concept , Ltd.2017-01-11
Desara TV, Desara Blue TV (K162201)Caldera Medical, Inc.2017-01-11
InSeca ARC Stylus, Aerin Console (K162810)Aerin Medical, Inc.2017-01-11
Epic Pro (K163128)Biolase, Inc.2017-01-11
Disc-FX System (K162490)Elliquence, LLC2017-01-06
SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader (K163142)ArthroCare Corporation2017-01-06
C2 Cryoballoon Ablation System (K161202)C2 Therapeutics, Inc.2017-01-05
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm (K163454)Ethicon Endo-Surgery, LLC2017-01-05
AGNES (K160469)Gowoonsesang Cosmetics Co., Ltd.2017-01-05
Relign System (K162770)Relign Corporation2017-01-04
Isolator Multifunctional Linear Pen (K163408)AtriCure, Inc.2017-01-03
SMARTO (K163308)Jeil Medical Corporation2016-12-27
XenMatrix AB Surgical Graft (K162193)C. R. Bard2016-12-23
Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator (K162721)Alliqua Biomedical, Inc.2016-12-22
DynaMesh-VENTRAL (K161550)Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft2016-12-22
derma+flex QS High Viscosity Tissue Adhesive (K162352)Chemence Medical, Inc.2016-12-22
IntelliCartTM System (K162421)Dornoch Medical Systems2016-12-21
NICO Myriad (K161307)Nico Corporation2016-12-21
AeroForm Tissue Expander System (DEN150055)Airxpanders, Inc.2016-12-21
Evolution Esophageal Stent System – Partially Covered (K162717)Cook Ireland, Ltd.2016-12-21
Ultravision Visual Clearing System (DEN150022)Alesi Surgical, Ltd.2016-12-20
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) (K160928)Hartalega Sdb. Bhd.2016-12-20
Endoform Plastics and Reconstructive Matrix (K162461)Aroa Biosurgery (Formerly Mesynthes Limited)2016-12-20
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture (K160854)Biomet Manafacturing Corp.2016-12-19
CleanCisionTM Wound Retraction and Protection System (DEN150038)Prescient Surgical2016-12-16
Zerona Z6 OTC (K162578)Erchonia Corporation2016-12-16
Pulsaderm ACE-All Blue (K162371)Nutra Luxe MD, LLC2016-12-15
PERMATAPE (K162247)Medos International SARL2016-12-15
PK AIM (K163373)Gyrus Acmi, Inc.2016-12-12
Photon, Photon Plus (K162114)Zolar Technology & Mfg Co., Inc.2016-12-12
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 (K162442)Gri Medical & Electrical Technology Co., Ltd.2016-12-12
InMode RF System (K163190)Inmode MD , Ltd.2016-12-12
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler (K160969)Shinemed, LLC2016-12-12
truSculpt (K162512)Cutera, Inc.2016-12-09
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System (K160487)Kci USA, Inc.2016-12-09
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) (K161632)Bios S.R.L.2016-12-08
Emprint Ablation System (K163105)Covidien, LLC2016-12-06
Tri-Staple 2.0 Intelligent Cartridge (K163098)Covidien, LLC2016-12-05
Discovery Pico Family (K163222)Quanta System Spa2016-12-05
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads (K161757)Victor Medical Instruments Co., Ltd.2016-12-05
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply (K161128)Medela AG2016-12-01
Voyant Open Fusion Device (K162676)Applied Medical Resources2016-12-01
WoundPro Negative Pressure Wound Therapy System (K150960)Pensar Medical, LLC2016-12-01
Osseointegrated Fixtures (K161548)Southern Implants (Pty), Ltd.2016-12-01
Litho (K163009)Quanta System Spa2016-12-01
CODMAN Integrated Bipolar Cord and Tubing Set (K163106)Medos International SARL2016-12-01
ESPADA Acne-Clearing Blue Light Pen (K162450)Foreo, Inc.2016-11-30
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