Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics (K171324)Surgical Instrument Service and Savings, Inc.2017-06-23
HyPHo Laser System (K163449)Hyper Photonics Srl2017-06-23
VITRUVIAN INFILTRATION PUMP (K170629)Black & Black Surgical, Inc.2017-06-22
Sterile Polyisoprene Powder Free Surgical Gloves (K171047)Better Care Plastic Technology Co., Ltd.2017-06-22
GOLNIT Non-Absorbable PTFE Surgical Suture (K163049)Antarma Dba Golnit Sutures2017-06-21
Biodesign Fistula Plug (K170016)Cook Biotech Incorporated2017-06-21
Premium Plus Disposable Barrier Sleeve (K163447)Premium Plus International Limited2017-06-20
DEKA MOTUS AX (K162886)El.En Electronic Engineering Spa2017-06-19
Diode Laser Hair Removal System (K162659)Shandong Huamei Technology Co., Ltd.2017-06-16
Silhouette InstaLift (K163676)Silhouette Lift, Inc.2017-06-16
TroClose1200, TroClose1200 Cannula (K171494)Gordian Surgical, Ltd.2017-06-15
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) (K170198)Cardinal Health, Inc.2017-06-15
sensiLift (K170499)El Global Trade, Ltd.2017-06-15
Alma Q (K170850)Alma Lasers , Ltd.2017-06-15
HydroMARK Breast Biopsy Site Markers (K170803)Devicor Medical Products, Inc.2017-06-15
Sculpsure (K171111)Cynosure, Inc.2017-06-13
SECRET RF (K170325)Ilooda Co,., Ltd.2017-06-13
Picocare (K162755)Wontech Co., Ltd.2017-06-12
Sterile Nitrile Surgical Gloves, Powder-free (K170515)Primus Gloves Pvt Limited2017-06-09
Cardinal Health Non-Reinforced Surgical Gown (K170762)Cardinal Health200, LLC2017-06-09
Laser Peripherals, LLC Family of Bare Laser Fibers (K170366)Laser Peripherals, LLC2017-06-08
Novosyn Quick Absorbable Suture (K170661)Aesculap, Inc.2017-06-08
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (K170763)Acell, Inc.2017-06-08
NEXA Negative Pressure Wound Therapy System (K162610)Nexa Medical , Ltd.2017-06-08
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K171066)Covidien, LLC2017-06-08
SurgiMend PRS Meshed, Revize-X (K171357)Integra Lifesciences Corporation (Owner of Tei Biosciences)2017-06-07
CURVE Laser System (K170709)Yolo Medical, Inc.2017-06-06
Magnetic Surgical System (K171429)Levita Magnetics International Corp2017-06-06
LS-5 ePTFE Suture (K163639)Lsi Solutions2017-06-02
Radiopaque Tissue Marker (K170026)Viscus Biologics, LLC2017-06-02
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners (K170278)C.R. Bard, Inc.2017-05-31
Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (K170626)Alma Lasers, Inc.2017-05-31
Ultravision Visual Field Clearing System (K170178)Alesi Surgical, Ltd.2017-05-26
SutureTape (K171296)Arthrex, Inc.2017-05-26
PicoWay Laser System (K170597)Syneron Candela Corporation2017-05-25
ACTION II Laser System (K163196)Lutronic Corporation2017-05-24
Cook Holmium Laser Fiber (K163197)Cook Incorporated2017-05-24
truFreeze System (K163244)CSA Medical, Inc.2017-05-24
Skylit Phototherapy System (K170489)Skylit Medical2017-05-23
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (K170121)Lumenis, Ltd.2017-05-22
PK AIM (K170908)Gyrus Acmi, Inc.2017-05-19
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip (K163261)AtriCure, Inc.2017-05-19
MICRORUPTOR 6 (K160677)Meridian AG2017-05-19
Lipogems System (K171135)Lipogems International Spa2017-05-18
SIROLaser Advance+ (K170500)Dentsply Sirona2017-05-16
ULTRASHAPE POWER SYSTEM (K170370)Syneron Medical, Ltd.2017-05-15
Dental 5 Multi Diode laser (K163638)Bio-Med USA, Inc.2017-05-15
GORE SYNECOR Preperitoneal Biomaterial (K163576)W. L. Gore & Associates, Inc.2017-05-11
Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator (K170990)Spiration, Inc.2017-05-11
Venus Silk.expert (K170734)Cyden Limited2017-05-08
Thermi Reusable Non-invasive RF Electrode (K171094)Thermgen, L.L.C2017-05-08
Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 (K170111)Pulsaderm, LLC2017-05-08
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) (K170152)Hartalega Sdn Bhd2017-05-05
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) (K162449)AngioDynamics, Inc.2017-05-05
Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (K163615)Carefusion 2200, Inc.2017-05-04
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (K163468)Cook Ireland, Ltd.2017-05-04
Hee HR Mini (K170269)Oriental Inspiration Limited2017-05-03
Iridex TruFocus LIO Premiere (K170718)Iridex Corporation2017-05-03
Silhouette Featherlift (K171005)Silhouette Lift, Inc.2017-05-03
Surgi Max Ultra (K170107)Elliquence, LLC2017-05-03
Collagen Meniscus Implant XL (K170364)Ivy Sports Medicine, LLC2017-05-02
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (K160781)Semperit Investments Asia Pte , Ltd.2017-05-02
XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack (K170334)Revmedx, Inc.2017-05-01
VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval (K170294)C. R. Bard2017-05-01
Bovie J-Plasma Precise FLEX Handpiece (K170777)Bovie Medical Corporation2017-05-01
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider (K162751)Surgical Instrument Services and Savings, Inc.2017-05-01
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159)Vr Medical Technologies, LLC2017-04-28
Biodesign Staple Line Reinforcement (K170945)Cook Biotech Incorporated2017-04-28
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) (K163667)Health Beacons, Inc.2017-04-28
Star Tissue Marker (K170905)Scion Medical Technologies, LLC2017-04-27
U.S. Laser Worx Patriot 1 family of lasers (K162334)U.S. Laser Worx2017-04-27
Cutera enlighten III Laser System (K170936)Cutera, Inc.2017-04-25
BC-001+ Acne Purifier (K170260)Oriental Inspiration Limited2017-04-25
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (K170869)Covidien2017-04-21
Aero Chrome* Select Breathable Performance Surgical Gowns (K162930)Halyard Health, Inc.2017-04-21
Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil (K170721)Precision Surgical, LLC2017-04-21
joimax Endovapor 2 (K170358)Joimax GmbH2017-04-21
DERMABOND PRINEO Skin Closure System (K163645)Ethicon, LLC2017-04-21
SlimShape System (K163415)Syneron Medical, Ltd.2017-04-20
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock (K170215)Patient Pocket, LLC2017-04-19
ECHELON CIRCULAR Powered Stapler (K163523)Ethicon Endo-Surgery, LLC2017-04-18
PICO Single Use Negative Pressure Wound Therapy System (K163387)Smith & Nephew Medical Limited2017-04-18
Model 330 Multifunction Aspirator (K170533)ZOLL Medical Corporation2017-04-18
Paxman Scalp Cooler (K163484)Paxman Coolers Limited2017-04-17
Saf-T-Vac Smoke and Fluid Evacuator (K170582)Surgical Technology Laboratories, Inc.2017-04-14
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 (K163329)Pulsaderm, LLC2017-04-14
PlasmaBlade T (K170610)Medtronic Advanced Energy2017-04-13
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners (K163698)C.R. Bard, Inc.2017-04-11
MEDICAL DIODE LASER SYSTEMS (K160549)Wuhan Gigaa Optronics Technology Co., Ltd.2017-04-07
NeuroBlate System (K170724)Monteris Medical,2017-04-07
UNO Negative Pressure Wound Therapy System (K161599)Genadyne Biotechnologies, Inc.2017-04-06
NobleStitch EL (K162617)Nobles Medical Technologies Ii, Inc.2017-04-06
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film (K170088)Medela AG2017-04-06
TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM (K170377)Richard Wolf Medical Instruments Corporation2017-04-05
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) (K170075)Airxpanders, Inc.2017-04-03
Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection (K170449)Millennium Medical Technologies, Inc.2017-03-31
MultiPulse HoPLUS (K161257)Asclepion Laser Technologies GmbH2017-03-31
New Deantronics E Green™ Electrosurgical Monopolar Pencils (K170161)New Deantronics Taiwan , Ltd.2017-03-29
Silk'n HST (K162784)Home Skinovations , Ltd.2017-03-25
LIGHTFUSION LED SYSTEM (K162556)Vitage Led, Ltd.2017-03-24
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