Atlas FDA

General, Plastic Surgery

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

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RecordFirmDate
VIRULITE COLD SORE MACHINE (DEN090012)Virulite, LLC2012-10-18
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N (K121861)Smith & Nephew, Inc.2012-10-18
DISPOSABLE SURGICAL GOWNS (K120192)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2012-10-16
AMS LARGE PORE POLYPROPHLENE MESH (K121805)American Medical Systems2012-10-16
ACCUMESH DEPLOYMENT SYSTEM (K123066)Covidien, LLC2012-10-16
ME HAIR2GO (K121598)Syneron Medical, Ltd.2012-10-12
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT (K121883)Kci USA, Inc. (Kinetic Concepts, Inc.)2012-10-11
BLUE SUI SLING (K121754)Boston Scientific Corp2012-10-10
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM (K120499)Kci USA, Inc. (Kinetic Concepts, Inc.)2012-10-05
REPROCESSED SURGICAL ELECTRIC INSTRUMENT (K120040)Sterilmed, Inc.2012-10-05
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING (K122756)Penumbra, Inc.2012-10-02
ULTHERA SYSTEM (K121700)Ulthera, Inc.2012-10-02
EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET (K122619)Applied Medical2012-10-02
SMARTLUX (K120460)Medmix Co., Ltd.2012-10-01
SERF ABLATION SYSTEM SERF ABLATION NEEDLE (K120116)Thermedical2012-10-01
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K113678)Medela AG2012-10-01
EPIC 10 (K121286)Biolase Technology, Inc.2012-09-28
FREEDOM ND: YAG LASER SYSTEM (K113843)Lutronic Corporation2012-09-27
COOLRAIL LINEAR PEN MODEL MCRI (K122611)AtriCure, Inc.2012-09-26
SURELASE CO2 LASER SYSTEM (K121580)Clinicon Corp.2012-09-25
ARTHREX SUTURE (UHMWPE) (K122374)Arthrex, Inc.2012-09-25
THE PL-1064 LASER SYSTEM (K120938)Sheaumann Laser, Inc.2012-09-24
ADIPREP ADIPOSE TRANSFER SYSTEM (K121005)Harvest Technologies, Corp.2012-09-21
ALMA LASERS FAMILY OF PIXEL RF TIPS (K121150)Alma Lasers, Inc.2012-09-21
MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP (K120235)Aerolase Medical Lasers, LLC2012-09-17
ORIGINS LIPOHARVESTING SYSTEM (K120328)Sound Surgical Technologies, LLC2012-09-17
BIOFIBER SYTURE (K122487)Tornier, Inc.2012-09-17
TRIA LASER HAIR REMOVAL SYSTEM (K120737)Tria Beauty, Inc.2012-09-13
VELASHAPE (K122579)Syneron Medical, Ltd.2012-09-13
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE (K121335)Hutchinson Sante S.N.C.2012-09-13
MINIARC PRO SINGLE-INCISION SLING SYSTEM (K121641)American Medical Systems2012-09-07
SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS (K113407)Carefusion 2200, Inc.2012-09-07
LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER (K113572)Covidien, Formerly Valleylab, A Division of Tyco H2012-09-05
PRECISE SHP DIODE LASER (K113472)CAO Group, Inc.2012-08-30
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 (K113291)Simex Medizintechnik GmbH2012-08-30
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP (K122276)AtriCure, Inc.2012-08-29
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK (K121251)Galil Medical , Ltd.2012-08-28
ULTHERA SYSTEM (K122528)Ulthera, Inc.2012-08-28
ERCHONIA ZERONA (K121695)Erchonia Corporation2012-08-23
FREEDOM INGUINAL HERNIA IMPLANT (K113552)Insightra Medical2012-08-23
THERMAL LIGATING SHEARS (K122086)Microline Surgical, Inc.2012-08-23
ETCHONIA ZERONA ARMS (K121690)Erchonia Corporation2012-08-23
MICROAIRE SURGICAL INSTRUMENTS LLC (K113128)Microaire Surgical Instruments, LLC2012-08-17
RESPROCESSED SERFAS ENERGY PROBE (K121855)Stryker Sustainability Solutions2012-08-16
GID 700 (K120902)The Gid Group, Inc.2012-08-15
C100 WRINKLE REDUCTION DEVICE (K112362)Silver Bay, LLC2012-08-14
MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 (K122246)Celleration, Inc.2012-08-13
SUCTION LIPOLASTY ACCESSORIES (K113795)Norman M. Black Iii2012-08-07
LTM-LABAROSCOPIC SURGICAL MESH (K121289)Lifecell Corp.2012-08-03
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (K121048)Boston Scientific Corp2012-08-03
MEDILAS H RFID LASER FIBER (K121938)Dornier Medtech America, Inc.2012-08-01
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT (K113199)Kevo Medical Supplies2012-07-30
ENDOBEAM HOLMIUM LASER FIBERS (K120926)C.R. Bard, Inc.2012-07-27
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES (K121897)Cardinal Health, Inc.2012-07-27
ORION (K113489)Asclepion Laser Technologies GmbH2012-07-27
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER (K121510)Covidien, Formerly US Surgical A Divison of Tyco H2012-07-25
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A (K120377)J. Morita USA, Inc.2012-07-25
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING (K113229)C.R. Bard, Inc.2012-07-20
POLARIS Q-SWITCH RUBY SYSTEM (K121162)Sandstone Medical Technologies, LLC2012-07-18
TIO2MESH TM (K113311)Biocer Entwicklungs GmbH2012-07-17
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER (K121474)Changzhou Kangdi Medical Stapler Co., Ltd.2012-07-16
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE (K121600)Ethicon Endo-Surgery, LLC2012-07-16
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) (K120827)Angiotech2012-07-13
PLANCET (K113513)Micropoint Technologies Pte, Ltd.2012-07-13
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE (K121767)Medtronic, Inc.2012-07-13
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER (K121113)Biopsy Sciences, LLC2012-07-12
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE (K121306)Arthocare Corporation2012-07-12
AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS (K121426)Synergetics, Inc.2012-07-10
LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS (K121471)Lightscalpel, LLC2012-07-10
SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR (K120244)Nexera Medical, Inc.2012-07-05
ILUMINAGE DIODE LASER (K111454)Cynosure, Inc.2012-07-05
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (K112634)Inotec Amd , Ltd.2012-07-03
PROGRIP LAPARSCOPIC SELF-FIXATING MESH (K120897)Sofradim Production2012-06-29
AC WOUND TREATMENT SYSTEM (K111949)Nanovibronix, Inc.2012-06-29
SC TIP CLEANER (K120581)Nsi2012-06-29
FIBEROPTIC LASER DELIVERY SYSTEM (K120810)Fiberoptic Fabrications, Inc.2012-06-28
SURGIMESH XB - SKIRTED (K120025)Aspide Medical2012-06-26
AQUAMANTRYS3 BSC 9.1S (K121290)Medtronic, Inc.2012-06-25
WAVELIGHT FS200 PATIENT INTERFACE 1505 (K121031)Alcon Research, Ltd.2012-06-21
ALPHA ORTHOPAEDICS AT2 SYSTEM (K120527)Alpha Orthopaedics, Inc.2012-06-18
GREENLIGHT MOXY FIBER OPTIC (K120870)American Medical Systems2012-06-15
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE (K121451)Medtronic, Inc.2012-06-14
MEDART 620 (K120573)Medart A/S2012-06-13
PARIETEX COMPOSITE VENTRAL PATCH (K120506)Sofradim Production2012-06-13
MACROLYTE DISPERSIVE ELECTRODE (K120476)Conmed Corporation2012-06-12
CONMED SUREFIT DUAL DISPERSIVE ELECTRODE (K120322)Conmed Corporation2012-06-12
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV (K120045)Exact Medical Manufacturing, Inc.2012-06-12
ARTISYN Y-SHAPED MESH (K113205)ETHICON, Inc.2012-06-11
EPLUS SKIN TREATMENT SYSTEM (K113868)Syneron, Ltd.2012-06-11
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) (K121507)AtriCure, Inc.2012-06-06
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM (K121515)Solta Medical, Inc.2012-06-05
CROSSFIX II MEMISCAL REPAIR DEVICE (K121413)Cayenne Medical, Inc.2012-06-04
LIGHT FOR WRINKLES (K120775)Led Intellectual Properties, LLC2012-06-04
MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES (K113597)Minilap Technologies2012-06-03
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT (K120033)Kci USA, Inc.2012-05-31
SHASER HRS2 HAIR REMOVAL SYSTEM (K120080)Shaser, Inc.2012-05-25
MOBILE VERSA LIGHT (K111049)Medtek Lighting Corp2012-05-25
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS (K120934)Cardinal Health, Inc.2012-05-23
ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP (K111262)Olsen Medical2012-05-23
PALOMAR VECTUS LASER (K120622)Palomar Medical Technologies, Inc.2012-05-23
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