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General, Plastic Surgery

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

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RecordFirmDate
DEPILASE YAG LASE PLUS LASER SYSTEM (K020463)Depilase Group , Ltd.2002-02-27
PULSION FS LASER KERATOME (K013941)Intra Lase Corp.2002-02-27
DIODENT DENTAL LASER SYSTEM (K013216)Continuum Electro-Optics, Inc.2002-02-27
LIFESTITCH SUTURING DEVICE (K013990)Edwards Lifesciences, LLC2002-02-27
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM (K013946)Afx, Inc.2002-02-27
LASER SYSTEM YELLOWSTAR (K013940)Asclepion-Meditec AG2002-02-26
AARON REUSABLE ELECTROSURGICAL ELECTRODE (K014201)Aaron Medical Industries2002-02-25
DEPILASE TWIN LASE LASER SYSTEM (K020412)Depilase Group , Ltd.2002-02-22
MODIFICATION TO WARTNER WART REMOVAL SYSTEM (K011708)Wartner Medical Products2002-02-20
SI ASCOPE (K011273)Astron Clinica Limited2002-02-20
MEDSURG EQUIPMENT COVERS (K014239)International Medsurg Connection2002-02-19
CANDELA SMOOTHBEAM LASER SYSTEM (K013825)Candela Corp.2002-02-15
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. (K014036)Medtrade Products , Ltd.2002-02-14
DISPOSABLE LIGHT HANDLE AND ADAPTOR (K020304)Aspen Surgical Products, Inc.2002-02-14
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS (K014288)Wrp Specialty Products Sdn. Bhd.2002-02-13
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 (K013904)Baylis Medical Co., Inc.2002-02-12
CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS (K014048)Clinicon Corp.2002-02-11
ENDOANCHOR AND OPENANCHOR (K013749)Ethicon Endo-Surgery, Inc.2002-02-11
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) (K013748)Candela Corp.2002-02-11
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 (K013864)Nidek, Inc.2002-02-08
GELZONE (K013732)Implantech Associates, Inc.2002-02-07
SMARTEPIL (K020107)Cynosure, Inc.2002-02-07
ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES (K013730)Novasys Medical, Inc.2002-02-06
POWDERFREE LATEX SURGEON'S GLOVES (K013914)Kanam Latex Industries Pvt. , Ltd.2002-02-06
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (K012676)Adven Medical2002-02-04
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K012694)Adven Medical2002-02-04
BERCHTOLD ELEKTROTOM 106 HITT (K013668)Berchtold Corp.2002-02-04
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (K013511)Aculux, Inc.2002-02-01
DYONICS ELECTROBLADE RESECTOR (K012314)Smith & Nephew, Inc.2002-02-01
NUCLEOTOMY INTRADISCAL CATHETER (K013622)Oratec Interventions, Inc.2002-01-31
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (K020077)Augustine Medical, Inc.2002-01-31
THERMAGE THERMACOOL TC SYSTEM (K013639)Thermage, Inc.2002-01-29
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS (K013641)Senorx, Inc.2002-01-29
SEEDNET, MODEL FP6T5, FP5T5, FP5T3 (K011950)Galil Medical , Ltd.2002-01-29
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED (K014021)Surgical Specialties Corp2002-01-28
MEDIPORT 2000 MOBILE (K013585)Servox Medizintechnik GmbH2002-01-28
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 (K013392)Medtronic Vascular2002-01-25
CRYOCARE SURGICAL SYSTEM (K011074)Endocare, Inc.2002-01-25
COALESCENT SURGICAL U-CLIP (K013664)Coalescent Surgical2002-01-24
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) (K020019)Wrp Asia Pacific Sdn. Bhd.2002-01-23
PRECISION PLUS TUNA OFFICE SYSTEM (K014224)Vidamed, Inc.2002-01-23
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX (K012602)Crosstex Intl.2002-01-22
DIOMED 15 DIODE LASER (K012398)Diomed, Ltd.2002-01-22
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD (K014222)Arthrocare Corp.2002-01-18
REPROCESSED ELECTROSURGICAL ELECTRODE (K012684)Sterilmed, Inc.2002-01-18
DURQ/ QUALIDURA (K013116)Ever-Safety Technical Service2002-01-18
NLITE SYSTEM,MODEL A00-1025 (K013461)Icn Photonics , Ltd.2002-01-17
SELF-DRILLING RADIOGRAPHIC MARKER (K014148)Walter Lorenz Surgical, Inc.2002-01-17
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER (K014234)Continuum Electro-Optics, Inc.2002-01-17
PERMACOL (K013625)Tissue Science Laboratories, Plc2002-01-17
SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 (K013560)Semperit Technische Produkte Gesellshaft2002-01-16
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY (K013416)Intuitive Surgical, Inc.2002-01-10
MISONIX IRRIGATION SYSTEM MOEDL BC20P (K013417)Misonix, Inc.2002-01-10
NLITE SYSTEM (K014130)Icn Photonics , Ltd.2002-01-08
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND (K014100)Opusdent , Ltd.2002-01-08
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS (K013365)Medical Bio Care Sweden AB2002-01-08
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR (K013366)Medical Bio Care Sweden AB2002-01-08
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) (K011190)Surx, Inc.2002-01-08
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR (K013718)Gynecare, A Div. of Ethicon, Inc.2002-01-08
L-25 ABSORBABLE SURIGCAL SUTURE (K013671)United States Surgical, A Division of Tyco Healthc2002-01-08
VIABAHN ENDOPROSTHESIS (K013648)W. L. Gore & Associates, Inc.2002-01-08
FOTONA DUALIS, FOTONA DUALIS PLUS (K011939)Fotona D.D.2001-12-27
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M (K011589)Bypass , Ltd.2001-12-26
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE (K013193)Biolitec, Inc.2001-12-21
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) (K011960)Lares Research, Inc.2001-12-21
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (K013901)Cardiofocus, Inc.2001-12-20
DIGICAP (K012199)Humana USA, Inc.2001-12-19
AUTO SUTURE SURGICAL STAPLES (K013860)United States Surgical, A Division of Tyco Healthc2001-12-19
MULTITAK SUTURE SNAP SYSTEM (K013177)Bonutti Research, Inc.2001-12-19
STELLARTECH COAGULATION SYSTEM (K013139)Stellartech Research Corp.2001-12-18
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (K013302)Allegiance Healthcare Corp.2001-12-17
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM (K011197)Lumenis2001-12-14
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (K013242)STERIS Corporation2001-12-13
INDIGO OPTIMA LASER SYSTEM (K013493)Ethicon Endo-Surgery, Inc.2001-12-13
MASTER & FRANK SURGICAL GOWNS (STERILE) (K012186)Master & Frank Ent. Co., Ltd.2001-12-07
LIGHT SABER INTRODUCER NEEDLE (K013040)Minrad, Inc.2001-12-07
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G (K013727)Smart Glove Corp. Sdn Bhd2001-12-07
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM (K013047)Mojca Valijavec2001-12-06
REPROCESSED SOFT TISSUE ABLATORS (K012631)Alliance Medical Corp.2001-12-06
PALOMAR SLP 1000 (K013028)Palomar Medical Products, Inc.2001-12-06
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE (K013683)Abbott Vascular, Inc.2001-12-06
CEMENT RESTRICTOR (K013663)Medtronic Sofamor Danek, Inc.2001-12-05
MICROMARK II TISSUE MARKER,MODEL C1535 (K013413)Ethicon Endo-Surgery, Inc.2001-12-03
MACROPORE SURGIWRAP (TS) (K012025)Macropore Biosurgery, Inc.2001-12-03
ENT LASERVISION (K012071)Union Medical USA2001-12-03
TRIMAX (K012268)Standard Textile Co., Inc.2001-12-03
MICRO STAMPING LIGATING CLIP (K013264)Micro Stamping Corp.2001-11-29
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT (K013324)Tillotson Healthcare Corp.2001-11-29
NEPTUNE WASTE MANAGEMENT STSTEM (K012991)Stryker Instruments2001-11-29
RUSCH POLYFLEX STENT KIT (K013266)Rusch Intl.2001-11-27
PERIOLASE ND:YAG DENTAL LASER SYSTEM (K010771)Millennium Dental Technologies, Inc.2001-11-27
STARS2000 POWER CANNULA (K012236)Kmi Kolster Methods, Inc.2001-11-19
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE (K011322)Dornier Medtech America, Inc.2001-11-19
CYNOSURE PHOTOGENICA VL (K012806)Cynosure, Inc.2001-11-19
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE (K013274)Cp Medical2001-11-16
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS (K013499)Diomed, Inc.2001-11-16
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 (K012819)Semperit Technische Produkte Gesellshaft2001-11-16
CYNOSURE PHOTOGENICA ER (K012790)Cynosure, Inc.2001-11-16
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) (K012880)Ssn Gloves (M) Sdn Bhd2001-11-16
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) (K012896)Ssn Gloves (M) Sdn Bhd2001-11-16
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