meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
41
Latest Decision
2002-01-23

Clearances · page 80 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K014224 PRECISION PLUS TUNA OFFICE SYSTEM Vidamed, Inc. GEI Class II 2002-01-23
K020019 POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) Wrp Asia Pacific Sdn. Bhd. KGO Class I 2002-01-23
K012398 DIOMED 15 DIODE LASER Diomed, Ltd. GEX Class II 2002-01-22
K012602 CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX Crosstex Intl. FXX Class II 2002-01-22
K014222 ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD Arthrocare Corp. GEI Class II 2002-01-18
K013116 DURQ/ QUALIDURA Ever-Safety Technical Service BTA Class II 2002-01-18
K012684 REPROCESSED ELECTROSURGICAL ELECTRODE Sterilmed, Inc. JOS Class II 2002-01-18
K013625 PERMACOL Tissue Science Laboratories, Plc FTM Class II 2002-01-17
K013461 NLITE SYSTEM,MODEL A00-1025 Icn Photonics , Ltd. GEX Class II 2002-01-17
K014234 MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER Continuum Electro-Optics, Inc. GEX Class II 2002-01-17
K014148 SELF-DRILLING RADIOGRAPHIC MARKER Walter Lorenz Surgical, Inc. NEU Class II 2002-01-17
K013560 SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 Semperit Technische Produkte Gesellshaft KGO Class I 2002-01-16
K013416 INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY Intuitive Surgical, Inc. GEI Class II 2002-01-10
K013417 MISONIX IRRIGATION SYSTEM MOEDL BC20P Misonix, Inc. GBX Class I 2002-01-10
K014130 NLITE SYSTEM Icn Photonics , Ltd. GEX Class II 2002-01-08
K011190 SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) Surx, Inc. MUK Class II 2002-01-08
K013718 GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR Gynecare, A Div. of Ethicon, Inc. OTO Class II 2002-01-08
K014100 OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND Opusdent , Ltd. GEX Class II 2002-01-08
K013671 L-25 ABSORBABLE SURIGCAL SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 2002-01-08
K013365 PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS Medical Bio Care Sweden AB GEX Class II 2002-01-08
K013366 PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR Medical Bio Care Sweden AB GEX Class II 2002-01-08
K013648 VIABAHN ENDOPROSTHESIS W. L. Gore & Associates, Inc. JCT Class II 2002-01-08
K011939 FOTONA DUALIS, FOTONA DUALIS PLUS Fotona D.D. GEX Class II 2001-12-27
K011589 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 Bypass , Ltd. NCA Class II 2001-12-26
K013193 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE Biolitec, Inc. GEX Class II 2001-12-21
K011960 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) Lares Research, Inc. GEX Class II 2001-12-21
K013901 MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) Cardiofocus, Inc. GEX Class II 2001-12-20
K012199 DIGICAP Humana USA, Inc. GAB Class I 2001-12-19
K013177 MULTITAK SUTURE SNAP SYSTEM Bonutti Research, Inc. GAM Class II 2001-12-19
K013860 AUTO SUTURE SURGICAL STAPLES United States Surgical, A Division of Tyco Healthc GDW Class II 2001-12-19
K013139 STELLARTECH COAGULATION SYSTEM Stellartech Research Corp. GEI Class II 2001-12-18
K013302 DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM Allegiance Healthcare Corp. KGO Class I 2001-12-17
K011197 DERMACLEAR UV-B PHOTOTHERAPY SYSTEM Lumenis FTC Class II 2001-12-14
K013242 AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS Corporation FTD Class II 2001-12-13
K013493 INDIGO OPTIMA LASER SYSTEM Ethicon Endo-Surgery, Inc. GEX Class II 2001-12-13
K012186 MASTER & FRANK SURGICAL GOWNS (STERILE) Master & Frank Ent. Co., Ltd. FYA Class II 2001-12-07
K013040 LIGHT SABER INTRODUCER NEEDLE Minrad, Inc. MDM Class I 2001-12-07
K013727 STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G Smart Glove Corp. Sdn Bhd KGO Class I 2001-12-07
K013047 FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM Mojca Valijavec GEX Class II 2001-12-06
K012631 REPROCESSED SOFT TISSUE ABLATORS Alliance Medical Corp. GEI Class II 2001-12-06
K013683 MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE Abbott Vascular, Inc. GAW Class II 2001-12-06
K013028 PALOMAR SLP 1000 Palomar Medical Products, Inc. GEX Class II 2001-12-06
K013663 CEMENT RESTRICTOR Medtronic Sofamor Danek, Inc. JDK Class II 2001-12-05
K012071 ENT LASERVISION Union Medical USA GEX Class II 2001-12-03
K012025 MACROPORE SURGIWRAP (TS) Macropore Biosurgery, Inc. FTL Class II 2001-12-03
K013413 MICROMARK II TISSUE MARKER,MODEL C1535 Ethicon Endo-Surgery, Inc. NEU Class II 2001-12-03
K012268 TRIMAX Standard Textile Co., Inc. FYA Class II 2001-12-03
K012991 NEPTUNE WASTE MANAGEMENT STSTEM Stryker Instruments FYD Class II 2001-11-29
K013324 HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT Tillotson Healthcare Corp. KGO Class I 2001-11-29
K013264 MICRO STAMPING LIGATING CLIP Micro Stamping Corp. FZP Class II 2001-11-29
K010771 PERIOLASE ND:YAG DENTAL LASER SYSTEM Millennium Dental Technologies, Inc. GEX Class II 2001-11-27
K013266 RUSCH POLYFLEX STENT KIT Rusch Intl. NYT Class II 2001-11-27
K011322 DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE Dornier Medtech America, Inc. GEX Class II 2001-11-19
K012806 CYNOSURE PHOTOGENICA VL Cynosure, Inc. GEX Class II 2001-11-19
K012236 STARS2000 POWER CANNULA Kmi Kolster Methods, Inc. QPB Class II 2001-11-19
K012880 STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) Ssn Gloves (M) Sdn Bhd KGO Class I 2001-11-16
K012896 STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) Ssn Gloves (M) Sdn Bhd KGO Class I 2001-11-16
K013274 MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE Cp Medical NEW Class II 2001-11-16
K012819 SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 Semperit Technische Produkte Gesellshaft KGO Class I 2001-11-16
K012790 CYNOSURE PHOTOGENICA ER Cynosure, Inc. GEX Class II 2001-11-16
K011586 IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE Diametrics Medical, Inc. GAA Class I 2001-11-16
K013499 DIOMED 15 PLUS AND DIOMED 30PLUS LASERS Diomed, Inc. GEX Class II 2001-11-16
K012544 VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM Vascular Architects, Inc. JCT Class II 2001-11-15
K013463 ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND Arthrocare Corp. GEI Class II 2001-11-15
K012738 SYMPHONY GRAFT DELIVERY SYSTEM (GDS) Depuyacromed GEY Class I 2001-11-14
K013402 VISULAS 532S Carl Zeiss, Inc. GEX Class II 2001-11-14
K013133 NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 Nordix, Inc. MOQ Class I 2001-11-13
K013603 MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 Ansell Healthcare Products, Inc. KGO Class I 2001-11-13
K013604 MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES Ansell Healthcare Products, Inc. KGO Class I 2001-11-13
K012682 REPROCESSED LASER PROBE Sterilmed, Inc. GEX Class II 2001-11-08
K012725 TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES Endo-Therapeutics, Inc. GEI Class II 2001-11-08
K012679 REPROCESSED RF ARTHROSCOPY PROBES Sterilmed, Inc. GEI Class II 2001-11-08
K012598 REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS Sterilmed, Inc. NUJ Class II 2001-11-07
K012603 REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS Alliance Medical Corp. NUJ Class II 2001-11-07
K011174 PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES Fotona D.D. GEX Class II 2001-11-07
K012700 VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS Vanguard Medical Concepts, Inc. GEI Class II 2001-11-07
K011070 DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR Moor Instruments, Ltd. GEX Class II 2001-11-07
K013255 SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF Ellman Intl., Inc. GEI Class II 2001-11-07
K012552 SCITON IMAGE HAIR REMOVAL LASER Sciton, Inc GEX Class II 2001-11-05
K012545 ARAMIS DERMATLOGIC LASER Lumedics, Ltd. GEX Class II 2001-11-05
K011175 W.O.M. LASER U100 W.O.M. World of Medicine GmbH GEX Class II 2001-11-01
K012695 VANGUARD REPROCESSED ARTHROSCOPIC WANDS Vanguard Medical Concepts, Inc. GEI Class II 2001-10-30
K012497 CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 Galil Medical , Ltd. GEH Class II 2001-10-30
K012462 THEKEN LARGE CEMENT RESTRICTOR Theken Surgical,Llc JDK Class II 2001-10-29
K013355 SPARC SLING SYSTEM American Medical Systems, Inc. OTN Class II 2001-10-26
K012809 SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 Power Medical Interventions, Inc. GDW Class II 2001-10-26
K012628 GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM Gynecare Center OTN Class II 2001-10-26
K013348 MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 Erbe USA, Inc. GEI Class II 2001-10-26
K012632 TOURNIQUET CUFF; PNEUMATIC TOURNIQUET Medical Instruments Technology, Inc. KCY Class I 2001-10-26
K012519 ARTHROCARE ELECTROSURGERY WANDS Arthrocare Corp. GEI Class II 2001-10-25
K002632 OXYGENATOR Adjunctive Therapeutics, Inc. KPJ Class II 2001-10-25
K012419 CONFORM SHEETING, MODEL IGEL Implantech Associates, Inc. MDA Class I 2001-10-24
K012955 COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER Bioform, Inc. NEU Class II 2001-10-22
K012625 REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS Alliance Medical Corp. GEI Class II 2001-10-22
K013059 STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) Stony Brook Surgical Innovations, Inc. GAQ Class II 2001-10-22
K012320 POWERPRO BATTERY SYSTEM Linvatec Corp. HAB Class I 2001-10-19
K012278 THEKEN SMALL CEMENT RESTRICTOR Theken Surgical,Llc JDK Class II 2001-10-17
K012237 MERTEX-PLUS REUSABLE SURGICAL DRAPE Mercan AB KKX Class II 2001-10-15
K012240 MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE Mercan AB FYA Class II 2001-10-15
K012883 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM Boston Scientific Corp ESW Class II 2001-10-12

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.