Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX (K120284)Coloplast A/S2012-05-23
REACH SURGICAL STAPLERS (K120179)Reach Surgical, Inc.2012-05-23
VILET VILET QUICK (K120556)Riverpoint Medical2012-05-23
PERMACOL SURGICAL IMPLANT (K120605)Covidien, LLC2012-05-18
EVOLUTION COLONIC STENT SYSTEM (K113510)Cook Ireland, Ltd.2012-05-17
RESTORELLE POLYPROPYLENE Y MESH (K112322)Coloplast A/S2012-05-17
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K112127)Smith & Nephew, Inc.2012-05-16
MLS, ZERONA-AD (K120257)Erchonia Medical, Inc.2012-05-14
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS (K121127)Cynosure, Inc.2012-05-13
TATTOOSTAR EFFECT Y (K112669)Asclepion Laser Technologies GmbH2012-05-11
AQUAMANTYS3 9.5 XL BIPOLAR SEALER (K120537)Medtronic, Inc.2012-05-10
VERTESSA (K120327)Caldera Medical, Inc.2012-05-10
OPHIRA MINI SLING SYSTEM (K110420)Promedon S.A2012-05-08
COBES SURGICAL DRAPE (K112378)Cobes Industries Co., Ltd.2012-05-08
GLOW BY ENDYMED (K120513)Endymed Medical, Ltd.2012-05-08
VEIN-GOGH INSTRUMENT (K112334)Refine USA, LLC2012-05-08
KIMBERLY-CLARK CHILD'S FACEMASK (K113340)Kimberly-Clark2012-05-04
ENDO CLIP III 5MM CLIP APPLIER (K121194)Covidien2012-05-03
HALO90 ULTRA ABLATION CATHETER (K120431)Barrx Medical, Inc.2012-05-03
ZELTIQ COOLSCULPTING (K120023)Zeltiq Aesthetics, Inc.2012-05-02
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K120983)Boston Scientific Corporation2012-05-02
ACCUMESH DEPLOYMENT SYSTEM (K121139)Covidien, LLC2012-05-02
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS (DEN110016)Ethicon Endo-Surgery2012-04-30
EPIFLO(R) (K120764)Neogenix, LLC2012-04-27
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING (K113707)Cardinal Health-Medical Products and Services2012-04-27
ECHOTIP(R) ULTRA FIDUCIAL NEEDLE (K111895)Wilson-Cook Medical Inc./Cook Endoscopy2012-04-27
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM (K120437)Biolitec Sia (Latvia)2012-04-26
C-QUR RPM MESH (K121070)Atrium Medical Corp.2012-04-26
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) (K120231)Biolitec Medical Devices, Inc.2012-04-24
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA (K113494)Nobles Medical Technologies Ii, Inc.2012-04-19
ON CALL CHOSEN LANCING DEVICE (K113332)ACON Laboratories, Inc.2012-04-18
SMARTEPIL,DEPILASE YAG LASE PLUS (K112141)Castle Laser Systems, Limited2012-04-13
NATURALASE CO2 LASER SYSTEM (K110333)Focus Medical, LLC2012-04-12
ETHEREA (K112505)Regulatory Insight, Inc.2012-04-06
ARTHREX BIO-SUTURE (K112899)Arthrex, Inc.2012-04-06
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND (K120095)Depuy Mitek, A Johnson & Johnson Company2012-04-06
ADVANTAGE LASER SYSTEM (K113502)Lutronic Corporation2012-04-05
EPICARE YAG (K113115)Light Age, Inc.2012-04-03
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES (K120065)Plaxtron Industrial (M) Sdn. Bhd.2012-04-03
CLEAR + BRILLIANT LASER SYSTEM (K120433)Solta Medical, Inc.2012-04-02
HYBRID GRAFT (K111695)Cook Biotech, Inc.2012-04-02
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM (K113233)Shen Wei (Usa), Inc.2012-03-29
FOTONA XP ND: YAG LASER SYSTEM (K113702)Fotona D.D.2012-03-28
INSULATION TESTER (K120416)Spectrum Surgical Supply Corp.2012-03-27
I-LIPO SYSTEM (K111501)Chromogenex Technologies Limited2012-03-23
GENII GI 4000 ELECTROSUGICAL GENERATOR (K113265)Genii, Inc.2012-03-22
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM (K113475)Endoscopic Technologies, Inc. D/B/A Estech2012-03-20
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE (K113763)Nobles Medical Technologies Ii, Inc.2012-03-16
INSORB ABSORBALBE STAPLE (K120373)Incisive Surgical, Inc.2012-03-16
LEVEEN SUPERSLIM NEEDLE ELECTRODE (K113090)Boston Scientific Corporation2012-03-15
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM (K113688)Biolitec Medical Devices, Inc.2012-03-13
OSTEOCOOL (TM) RF ABLATION SYSTEM (K111523)Baylis Medical Co., Inc.2012-03-13
VISUAL-ICE CRYOABLATION SYSTEM (K113860)Galil Medical, Inc.2012-03-12
IFS LASER SYSTEM (K113151)Abbott Medical Optics, Inc.2012-03-08
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES (K113810)Alma Lasers, Inc.2012-03-08
PUREGRAFT 850/PURE SYSTEM (K113255)Cytori Therapeutics, Inc.2012-03-07
VENUS FREEZE (MP)2 SYSTEM (K111670)Venus Concept , Ltd.2012-03-02
OASYS SURGICAL LIGHT CONTROLLER (K112133)Oasys Healthcare2012-03-01
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS (K120258)Covidien, Formerly US Surgical A Divison of Tyco H2012-02-29
TISSUE MARKER (K113202)Focal Therapeutics2012-02-28
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN (K113545)Depuy Mitek, A Johnson & Johnson Company2012-02-27
BLUESHINE'S GOLD SERIES (K110375)Blueshine Srl2012-02-23
COLLAGEN RIBBON (K120019)Wrightmedicaltechnologyinc2012-02-23
SPECTRA LASER SYSTEM (K113588)Lutronic Corporation2012-02-22
POWDERFREE POLYISOPRENE SURGICAL GLOVES (K112654)Pt. Medisafe Technologies2012-02-17
CHROMOPHARE F 628 AND F 528 (K120392)Berchtold GmbH & Co. KG2012-02-16
STLASE (K111689)Dental Photonics, Inc.2012-02-16
TEPHAFLEX LIGHT MESH (K113721)Tepha, Inc.2012-02-15
TEPHAFLEX MESH (K113723)Tepha, Inc.2012-02-15
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (K113496)Coloplast A/S2012-02-14
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) (K113390)Meridian AG2012-02-14
ESOPHAGEAL TTS STENT (K113551)Taewoong Medical Co., Ltd.2012-02-14
AMID STAPLER (K120268)Safestich Medical, LLC2012-02-10
EIGR SURGICAL ILLUMINATION SYSTEM (K113697)Invuity, Inc.2012-02-10
EXTRICARE (K110078)Devon Medical Products, Inc.2012-02-10
CLEARFLASH AC2100 COSMETIC SYSTEM (K111937)Clearflash Technologies, Inc.2012-02-08
TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT (K113021)CSA Medical, Inc.2012-02-07
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE (K111959)Aesculap, Inc.2012-02-06
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) (K113744)Angiotech2012-02-01
BIOGEL (R) INDICATOR (R) UNDERGLOVE (K111413)Molnlycke Health Care Us, LLC2012-01-30
ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT (K112600)AngioDynamics, Inc.2012-01-30
BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE (K112233)Bovie Medical Corporation2012-01-27
CYNOSURE CELLULAZE LASER (K102541)Cynosure, Inc.2012-01-26
LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM (K111986)Surgical Innovations Plc2012-01-26
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD (K111337)Tornier, Inc.2012-01-25
MEGABEAM ENDO-ENT PROBE (K113858)Biolitec Medical Devices, Inc.2012-01-24
SURGICAL TISSUE MANAGEMENT SYSTEM (K111202)Olympus Medical Systems Corp.2012-01-20
QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE (K113800)Angiotech2012-01-20
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE (K113709)Biolitec Medical Devices, Inc.2012-01-20
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE (K113792)Biolitec Medical Devices, Inc.2012-01-19
QUASAR CALYPSO (K111286)Silver Bay, LLC2012-01-18
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER (K112013)Biolitec, Inc.2012-01-13
CABLECAP (K113330)Sensormed2012-01-12
SYNERGY TISSUE MATRIX (K113460)Synovis Orthopedic & Woundcare2012-01-11
PROPATCH SOFT TISSUE REPAIR MATRIX (K110581)Cryolife, Inc.2012-01-10
PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K112458)Medica-Rents Co., Ltd.2012-01-05
HALO60 ABLATION CATHETER (K112454)Barrx Medical, Inc.2012-01-05
CERTUS 140 2.45GHZ ABLATION SYSTEM (K113237)Neuwave Medical, Inc.2012-01-04
BIOMERIX COMPOSITE SURGICAL MESH (K112499)Biomerix Corporation2011-12-23
BIOMERIX ASSURE (K112567)Biomerix Corporation2011-12-23
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