Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
NICO TRIOwand (K162075)Nico Corporation2016-08-11
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply (K153209)Smith & Nephew Medical, Ltd.2016-08-04
IPL Therapy Machine (K161286)Beijing Adss Development Co., Ltd.2016-08-04
EndyMed Contour Handpiece (K161199)Endymed Medical, Ltd.2016-08-01
Cianna Medical SAVI Scout Reflector and SAVI Scout System (K161507)Cianna Medical, Inc.2016-07-29
Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating (K161558)Bovie Medical Corporation2016-07-29
Bright (K161849)Tanda Beauty Canada, Inc.2016-07-29
Medilas H Laser Fibers (K161771)Dornier Medtech America, Inc.2016-07-28
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE (K161008)Hartalega Sdn Bhd2016-07-28
Cardinal Health Isolation Gown (K160339)Cardinal Health200, LLC2016-07-28
Waterlase Express (K161669)Biolase, Inc.2016-07-28
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (K161020)Revmedx, Inc.2016-07-28
DuraLazeTM HoLEP Laser Fiber (K153124)Medkey, LLC2016-07-26
truFreeze System (K161557)CSA Medical, Inc.2016-07-26
VITRUVIAN ULTIMATE ASPIRATOR (K161722)Black & Black Surgical, Inc.2016-07-26
INTRAcel Premium Fractional RF Micro Needle (FRM) System (K153727)Jeisys Medical, Inc.2016-07-21
SculpSure (K160470)Cynosure, Inc.2016-07-21
XP1100 RF (K152731)BTL Industries, Inc.2016-07-20
OsteoFab Patient Specific Facial Device (K161052)Oxford Performance Materials, Inc.2016-07-20
Operio (K153498)Toul Meditech AB2016-07-20
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider (K160333)Surgical Instrument Service and Savings, Inc.2016-07-20
Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload (K161137)Cardica, Inc.2016-07-20
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (K160271)San-M Package Co., Ltd.2016-07-15
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved (K153087)Ivy Sports Medicine, LLC2016-07-14
Biopor, AOC Porous Polyethylene, Cerepor (K160988)Ceremed , Inc.2016-07-14
LOOK PTFE Suture (K160744)Surgical Specialties Corporation2016-07-13
E-Pack Procedure Kit (K161726)ETHICON, Inc.2016-07-12
CryoDose H or Similar (K161337)Nuance Medical, LLC2016-07-12
InMode Plus System (K153568)Inmode MD , Ltd.2016-07-12
ACE Electrosurgical Resection and Vaporization Electrodes Series (K153055)Ace Medical Devices Pvt. , Ltd.2016-07-11
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (K160875)Cardinal Health, Inc.2016-07-11
sensiLight Mini (K161089)El Global Trade, Ltd.2016-07-08
PlasmaBlade TnA Tonsil and Adenoid Dissection Device (K152703)Medtronic Advanced Energy2016-07-08
ULTRASHAPE POWER SYSTEM (K160896)Syneron Medical, Ltd.2016-07-08
Habib EUS RFA (K161305)Emcision , Ltd.2016-07-07
Voyant Fine Fusion (K153017)Applied Medical Resources2016-07-06
Cool Renewal (K161296)Cool Renewal, LLC2016-07-06
PicoWay Laser System (K160607)Syneron Candela Corporation2016-07-05
3 Series Phototherapy Unit (K153749)Daavlin Distributing Company2016-06-30
Lite Touch (K152737)Focus Medical, LLC2016-06-29
ClariFix Device (K160669)Arrinex, Inc.2016-06-24
Quiver Laparoscopic Extendable (K153472)Itl Corporation Pty, Ltd.2016-06-23
JustRight Surgical Vessel Sealing System (K160602)Justright Surgical2016-06-23
Acne Light Therapy Wand (K160691)Zuko, Inc.2016-06-21
Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator (K161134)Bovie Medical Corporation2016-06-20
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... (K160451)Kci USA, Inc. (Kinetic Concepts, Inc.)2016-06-20
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (K153076)Teleflexmedical, Inc.2016-06-16
Endoform Reconstructive Template (K153632)Aroa Biosurgery Limited (Formerly Mesynthes Limited)2016-06-16
Tria Sapphire (K160821)Tria Beauty, Inc.2016-06-15
Disposable Surgical Face Mask (K153496)Xiantao Rayxin Medical Products Co., Ltd.2016-06-15
BiZact Open Sealer/Divider (K160539)Covidien2016-06-15
Magnetic Surgical System (DEN150007)Levita Magnetics International Corp2016-06-13
VersaWrap Tendon Protector (K160364)Alafair Biosciences, Inc.2016-06-10
ATOVEN-Reusable Laser Fiber (K152667)Diotech CO2016-06-09
Miromatrix Biological Mesh (K160400)Miromatrix Medical, Inc.2016-06-08
Disposable Barrier Sleeves and Covers (K160232)Dentsply International, Inc.2016-06-07
LunulaLaser (K153164)Erchonia Medical, Inc.2016-06-03
Communicator Surgical Facemask with Clear Window (K152561)Prestige Ameritech , Ltd.2016-06-03
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device (K153611)Ethicon, LLC2016-06-03
Helios III (K152856)Laseroptek Co., Ltd.2016-06-02
O-pel Laser and families of probe delivery devices (K160012)Precise Light Surgical2016-06-02
ABC D-FLEX PROBE (K151229)Conmed Corporation2016-06-02
Voyant Open Fusion Device (K153288)Applied Medical Resources2016-06-01
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K160623)M/s. Meril Endo Surgery Private Limited.2016-05-31
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners (K160900)C.R. Bard, Inc.2016-05-31
Noxilizer Surgical Ruler (K160501)Noxilizer, Inc.2016-05-26
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221)Cook Biotech Incorporated2016-05-26
Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy (K152423)Sunfire Industries, Inc.2016-05-20
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL (K152842)Boston Scientific Corporation2016-05-19
Filbloc (K150553)Assut Europe2016-05-19
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 (K152452)Medtek Lighting Corp D/B/A Peacock Tanning2016-05-19
C2 CryoBalloon Focal Pear Catheter (K160994)C2 Therapeutics, Inc.2016-05-19
Valleylab REM Polyhesive Infant Patient Return Electrode (K160290)Covidien, LLC2016-05-19
Vario 8/18/ci (K153663)Medela AG2016-05-18
PicoSure Workstation (K160480)Cynosure, Inc.2016-05-17
UltraCor Twirl Breast Tissue Marker (K152510)Bard Peripheral Vascular, Inc.2016-05-13
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay (K153236)C.R. Bard, Inc.2016-05-13
Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) (K153316)Cardinal Health, Inc.2016-05-12
Genteel Lancing Device (K153670)Genteel, LLC2016-05-12
Monopolar single-use HF cable (K160053)Olympus Winter & Ibe GmbH2016-05-06
HydroMARK Breast Biopsy Site Marker (K161021)Devicor Medical Products, Inc.2016-05-05
ERBE ESU Model VIO dV with Accessories (K150364)Erbe Elektromedizin GmbH2016-05-05
Alma Diode Tabletop Laser (K160952)Alma, Ltd.2016-05-05
Certus 140 2.45GHz Ablation System (K160936)Neuwave Medical, Inc.2016-05-04
Electrosurgical Generator ESG-200 (K160639)Olympus Winter & Ibe GmbH2016-05-04
SERFAS 90-S Electrosurgical Probe (K160050)Stryker Corporation2016-05-03
HEX tanning booth (K152336)J & B Products Ltd Dba Hex Tanning2016-05-02
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (K153745)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2016-05-02
Standard Clamp (K153358)Standard Bariatrics2016-05-02
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft (K160869)Cook Biotech Incorporated2016-04-29
T-32;T-40;T-44;T-52;T-72;TT-50 (K152412)Tanses Technologies, Inc.2016-04-29
Blockade Surgical Gown (K150598)Medline Industries, Inc.2016-04-28
Endopath Electrosurgery Probe Plus II (K160128)Ethicon Endo-Surgery, LLC2016-04-28
Signia Stapler (K160176)Covidien2016-04-26
Stryker Neptune 3 Waste Management System (K153407)Stryker Corporation2016-04-25
ACCENTO / HWA Dual/Single laser (K160227)Bison Medical Co, Ltd.2016-04-22
Disposable General Electrode (K152059)Modern Medical Equipment Manufacturing Limited2016-04-21
VirtuoSaph Plus Endoscopic Vessel Harvesting System (K160206)Terumo Cardiovascular Systems Corporation2016-04-21
VASOVIEW HemoPro Endoscopic Vessel Harvesting System (K153194)Maquet Cardiovascular, LLC2016-04-19
Forma System, Forma Light System (K160195)Formatk Systems , Ltd.2016-04-15
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