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General, Plastic Surgery

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

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RecordFirmDate
COMPRESSION ANASTOMOSIS RING (CAR) (K050356)Niti Medical Technologies , Ltd.2005-05-05
ERCHONIA EVRL LASER (K050672)Erchonia Medical, Inc.2005-05-02
AMSINO SUTURE REMOVAL KIT (K050656)Amsino International, Inc.2005-05-02
DIODENT II DENTAL LASER SYSTEM (K050274)Hoya Photonics, Inc.2005-04-29
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS (K050950)Active Optical Systems, Ltd./Efraim Bidas2005-04-29
NITI-S STENT & INTRODUCER, MODEL EOXXXX (K041648)Taewoong Medical Co., Ltd.2005-04-28
COMPEL SURGICAL GOWNS (K041539)Standard Textile Co., Inc.2005-04-28
AIP INTENSE PULSED LIGHT SYSTEM (K041554)Aesthera Corporation2005-04-27
MICROMEDICS SPHENOID SINUS STENT (K050340)Micromedics, Inc.2005-04-27
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES (K050508)Haywood Vocational Opportunities2005-04-27
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (K050256)Apple Medical Corp.2005-04-26
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE (K050533)Regent Medical Americas, LLC2005-04-26
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX (K042526)Medical Action Industries, Inc.2005-04-25
MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 (K050165)Cyden Limited2005-04-19
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT (K050695)Daavlin Distributing Co.2005-04-19
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 (K050699)Amedica Corp.2005-04-15
SPECTRA-SP CO2 LASER SYSTEM (K050254)Max Engineering , Ltd.2005-04-15
STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K043250)Stryker Leibinger2005-04-15
OCULIGHT GL/GLX (K050562)Iridex Corp2005-04-14
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K050181)Medigloves , Ltd.2005-04-13
AURORA DS, DS APPLICATOR (K050796)Syneron Medical, Ltd.2005-04-12
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A (K050831)Stellartech Research Corp.2005-04-12
GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR (K050193)Louis M. Gerson Co., Inc.2005-04-11
LUPINE LOOP (K050771)Depuy Mitek, A Johnson & Johnson Company2005-04-08
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE (K041515)Sutures India Private Limited2005-04-08
SURGITRON RADIOLASE II (K042710)Ellman Int'L, Inc.2005-04-07
ENDOTINE RIBBON (K050611)Coapt Systems, Inc.2005-04-06
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES (K043539)Demetech Corp.2005-04-06
ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM (K050671)Surgrx, Inc.2005-04-01
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS (K050548)Surgical Specialties Corp2005-04-01
CUTERA SOLERA OPUS AESTHETIC PRODUCT (K050679)Cutera, Inc.2005-03-31
NEOTHERMIA EN-BLOC BIOPSY SYSTEM (K050737)Neothermia Corporation2005-03-31
GRAFTSAVER (K043515)Vescare, Inc.2005-03-31
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY (K050047)Cutera, Inc.2005-03-31
BIOSYAG 50 MED (K043521)Bios S.R.L.2005-03-24
MEGA POWER ELECTROSURGICAL GENERATOR (K050579)Megadyne Medical Products, Inc.2005-03-24
OXYBAND WOUND DRESSING (K043063)Oxyband Technologies, Inc.2005-03-24
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K050021)Vascular Solutions, Inc.2005-03-18
OMNILUX REVIVE AND BLUE (K043329)Photo Therapeutics Limited2005-03-18
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS (K050293)Fotona D.D.2005-03-18
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE (K050184)Regent Medical Americas, LLC2005-03-16
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES (K032666)Medline Industries, Inc.2005-03-16
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 (K043004)Viasys Medsystems2005-03-16
COMPEL MLR SURGICAL GOWNS (K041541)Standard Textile Co., Inc.2005-03-16
VAPORMAX (K050412)Trimedyne, Inc.2005-03-14
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER (K050344)Ethicon Endo Surgery, Inc.2005-03-14
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE (K050361)Boston Scientific Corp2005-03-14
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS (K050108)Innovaquartz2005-03-14
UNDER BUTTOCKS DRAPE (K042893)International Medsurg Connection, Inc.2005-03-11
RELIANT LASER II SYSTEM AND ACCESSORIES (K042319)Reliant Technologies, Inc.2005-03-10
SIS FISTULA PLUG (K050337)Cook Biotech, Inc.2005-03-09
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM (K050364)Valley Forge Scientific Corp.2005-03-09
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT (K050148)Mentor Corporation2005-03-09
AURORA SR AND SRA APPLICATOR (K050452)Syneron Medical, Ltd.2005-03-09
MEDLINE SURGICAL GOWNS (K043585)Medline Industries, Inc.2005-03-08
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS (K043017)Medline Industries, Inc.2005-03-08
FEATHERLIFT EXTENDED APTOS THREAD (K043591)Kmi Kolster Methods, Inc.2005-03-04
CONTOUR NECKLIFT THREADS (K050247)Surgical Specialties Corp2005-03-04
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 (K043486)Topcon Medical Laser Systems, Inc.2005-03-03
GYRUS PLASMA SKIN RESURFACING SYSTEM (K041999)Gyrus Medical, Inc.2005-03-02
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR (K043133)Ceremed , Inc.2005-03-02
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM (K050347)Endocare, Inc.2005-02-25
VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER (K050223)Vivant Medical, Inc.2005-02-24
ELLIPSE LIGHT SPT (K043255)Danish Dermatologic Development A/S2005-02-24
BURANE XL (K050317)Wavelight Laser Technologie AG2005-02-24
DERMILLUME, MODEL PRO1000 (K043575)Care Electronics, Inc.2005-02-24
QUADRANT RETRACTOR SYSTEM (K043602)Medtronic Sofamor Danek2005-02-23
PSD-60/ENDOPLASMA (K042274)Olympus Shirakawa Co., Ltd.2005-02-22
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES (K050187)Sofradim Production2005-02-18
SURGICAL FACE MASK (K043199)Hong YA Non-Woven Products Co., Ltd.2005-02-16
WAVELIGHT SINON (K050218)Wavelight Laser Technologie AG2005-02-15
MONARCH NASAL IMPLANT (K041690)Hanson Medical, Inc.2005-02-11
ELECTROSURGICAL PENCILS (K040780)Hangzhou Shuyou Medical Instrument Company, Ltd.2005-02-10
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B (K043251)Candela Corp.2005-02-09
GEL MARK V (K050090)Senorx, Inc.2005-02-07
SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY (K050161)Conmed Electrosurgery2005-02-03
FOOTHILLS SURGICAL DRAPES (K041224)Foothills Industries, Inc.2005-02-03
COOLTOUCH, MODEL CT3S (K043046)New Star Lasers, Inc.2005-02-01
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL (K050102)Megadyne Medical Products, Inc.2005-02-01
CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT (K050069)Cutera, Inc.2005-01-31
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES (K043173)Lumenis, Ltd.2005-01-31
V.A.C. GRANUFOAM SILVER DRESSING (K041642)Kinetic Concepts, Inc.2005-01-25
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K043508)Ansell Healthcare Products, LLC2005-01-19
SOUNDSKIN PHOTOTHERAPY SYSTEM (K040103)Bhc International, Ltd.2005-01-18
THERMAGE THERMACOOL SYSTEM (K043402)Thermage, Inc.2005-01-14
PALOMAR STARLUX PULSED LIGHT SYSTEM (K041086)Palomar Medical Products, Inc.2005-01-13
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E (K042567)Pt. Medisafe Technologies2005-01-13
PALOMAR LUX1064 HANDPIECE (K041879)Palomar Medical Technologies, Inc.2005-01-13
CYNERGY LASER (K043429)Cynosure, Inc.2005-01-12
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR (K043544)Medela AG2005-01-07
LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS (K043273)Valleylab2005-01-05
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (K043310)Synthes (Usa)2005-01-05
UNICRYL (K042288)United Medical Industries Co. , Ltd.2004-12-27
MTF ALLOGRAFT ANCHOR (K042038)Musculoskeletal Transplant Foundation2004-12-23
GORE POLYPROPYLENE HERNIA MESH (K043081)W. L. Gore & Associates, Inc.2004-12-22
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K043056)W. L. Gore & Associates, Inc.2004-12-22
NOVASYS TRANSURETHRAL RF SYSTEM (K042132)Novasys Medical, Inc.2004-12-21
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS (K042000)Msq (M2) , Ltd.2004-12-21
SERFAS ENERGY SYSTEM (K041810)Stryker Endoscopy2004-12-21
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 (K043291)Medtronic Vascular2004-12-21
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