meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
31
Latest Decision
2010-04-15

Clearances · page 55 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090744 CLARO Clrs Technology Corporation OLP Class II 2010-04-15
K093695 PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE Peak Surgical, Inc. GEI Class II 2010-04-13
K092066 PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE Andrew Technologies, LLC QPB Class II 2010-04-12
K100384 FIBERLASE C02 LASER WAVEGUIDE Lumenis, Ltd. GEX Class II 2010-04-12
K093932 ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH Ethicon GmbH FTL Class II 2010-04-09
K100284 LIQUIBAND ULTIMA, LUT 003 Medlogic Global Limited MPN Class II 2010-04-09
K100224 ESTECH COBRA BIPOLSR II Endoscopic Technologies, Inc. D/B/A Estech GEI Class II 2010-04-07
K094041 ALPHA ORTHOPAEDICS AT3 SYSTEM Alpha Orthopaedics GEI Class II 2010-04-07
K093845 ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 ETHICON, Inc. GDW Class II 2010-04-07
K100120 ALEXIS ORTHOPAEDIC WOUND RETRACTOR Applied Medical Resources Corp. KGW Class II 2010-04-02
K100230 SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V Eleme Medical, Inc. NUV Class II 2010-04-02
K093010 MACH LED MC Dr. Mach GmbH & Co. KG FSY Class II 2010-04-01
K093009 MACH LED SC Dr. Mach GmbH & Co. KG FSY Class II 2010-04-01
K100641 INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) Relievant Medsystems GEI Class II 2010-03-30
K100270 ARTISAN AESTHETIC SYSTEM Palomar Medical Technologies, Inc. GEX Class II 2010-03-29
K093524 PIVIT A/B ST AND PIVIT A/B ST-R Tyrx, Inc. FTL Class II 2010-03-26
K093048 D-STORM 810NM, D-STORM 980NM Light Instruments GEX Class II 2010-03-23
K093115 KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 Kimberly-Clark Corp. FYA Class II 2010-03-19
K092149 BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 Bovie Medical GEI Class II 2010-03-18
K094028 CP-FIBER (ORTHOFIBER) Cp Medical GAT Class II 2010-03-18
K100035 MODEL VISULAS 532S LASER WITH THE VITE OPTION Carl Zeiss Meditec, AG GEX Class II 2010-03-17
K100395 HARMONY VLED SURGICAL LIGHTNING SYSTEM STERIS Corporation FST Class II 2010-03-17
K100572 VERSACLOSE, MODEL VC-200-01 Anulex Technologies, Inc. GAT Class II 2010-03-17
K100485 GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, Inc. OTN Class II 2010-03-16
K100474 QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W Quicklase Limited GEX Class II 2010-03-16
K092726 MESH GPS - LARGE, SMALL, SM, SM SMALL Surgical Structures , Ltd. OQL Class II 2010-03-15
K093852 EZLASE 3 LASER SYSTEM Biolase Technology, Inc. GEX Class II 2010-03-12
K092383 BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 Bovie Medical Corporation GEI Class II 2010-03-10
K093526 V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2010-03-10
K100053 MATTIOLI PULSE TWO/THREE PLUS FAMILY Mattioli Engineering Corp. ONF Class II 2010-03-10
K100506 FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK Teleflex Medical GAT Class II 2010-03-10
K092538 REFINE SUPPORT SYSTEM, MODEL 100.0100 Alure Medical, Inc. FTL Class II 2010-03-05
K092460 STAR-LITE -LM, MODEL SL8809 Ps Advanced Engineering OHS Class II 2010-03-05
K092326 SMOOTHCOOL Jeisys Medical, Inc. ONF Class II 2010-03-05
K093594 MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER Acclarent, Inc. KAM Class I 2010-03-03
K100386 DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 Changzhou Waston Medical Appliance Co., Ltd. GDW Class II 2010-03-01
K093203 CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 Medtronic, Inc. GEI Class II 2010-02-26
K100228 VERSAPULSE MODEL P20 LASER SYSTEM Lumenis, Inc. GEX Class II 2010-02-24
K093086 ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 Orthodynamix, LLC GEI Class II 2010-02-23
K092580 TIDI FACEMASK Tidi Products,Llc FXX Class II 2010-02-23
K092144 BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR Endochoice, Inc. ESW Class II 2010-02-22
K093793 LS-40 CO2 LASER SYSTEM MODEL LS-40 Sandstone Medical Technologies, LLC GEX Class II 2010-02-18
K093064 TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 Somatex Medical Technologies GmbH NEU Class II 2010-02-17
K100251 G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 Usgi Medical GAT Class II 2010-02-17
K100242 AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER Surgical Devices, A Division of Tyco Healthcare FZP Class II 2010-02-17
K100078 MODIFIED STRAIGHT FIRE LASER FIBER Boston Scientific Corp GEX Class II 2010-02-12
K092800 ANTI-WRINKLE (AGING) LIGHT, MODEL AAL Led Intellectual Properties, LLC ONE Class II 2010-02-04
K082230 VECTRA PLUS LASER SYSTEM AND ACCESSORIES Xintec Corporation GEX Class II 2010-02-03
K100090 IMPLANTABLE CLIP Genicon FZP Class II 2010-02-02
K093310 GEM FLOW COUPLER DEVICE AND SYSTEM Synovis Micro Companies Alliance, Inc. MVR Class II 2010-02-01
K093112 DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE Coloplast Manufacturing Us, LLC GAW Class II 2010-02-01
K092508 FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, Smith & Nephew, Inc. GAT Class II 2010-01-28
K093386 CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST Bfw, Inc. FST Class II 2010-01-28
K100076 ATRIUM C-QUR OVT MESH Atrium Medical Corp. FTL Class II 2010-01-26
K092224 TIGR SURGICAL MESH , MODEL WK-6 Novus Scientific Pte, Ltd. FTL Class II 2010-01-25
K093162 FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID Fotona D.D. GEX Class II 2010-01-22
K093075 ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT Aragon Surgical, Inc. GEI Class II 2010-01-21
K091674 ARTHROCARE COBLATOR IQ SYSTEM Arthrocare Corp. GEI Class II 2010-01-15
K091259 ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS Ethicon Endo-Surgery, Inc. GEI Class II 2010-01-15
K093855 HALO 360 & SIZING BALLOON, MODEL 3441C Barrx Medical, Incorporated GEI Class II 2010-01-15
K090271 HYDROCOAT MESH Promethean Surgical Devices, Inc. FTL Class II 2010-01-14
K082097 DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE Demetech Corp. NEW Class II 2010-01-08
K090025 MATRIX RF APPLICATOR Syneron Medical, Ltd. GEI Class II 2010-01-08
K093008 HALO ABLATION CATHETER, MODEL 90-9100 Barrx Medical, Incorporated GEI Class II 2010-01-08
K093502 VARI-LASE ENDOVENOUS LASER CONSOLE Vascular Solutions, Inc. GEX Class II 2010-01-07
K092923 CYTORI PUREGRAFT 250/PURE SYSTEM Cytori Therapeutics, Inc. MUU Class II 2010-01-06
K093465 FUSION SYSTEM Eclipsemed Global, Inc. ONF Class II 2010-01-05
K090312 TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC Tria Beauty, Inc. GEX Class II 2010-01-05
K082586 LIGHTWAVE PROFESSIONAL DELUXE Lightwave Technologies, LLC GEX Class II 2010-01-04
K091585 VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 Kci USA, Inc. OMP Class II 2009-12-29
K093067 LIPOSE DISPOSABLE CANNULA Lipose Corp. QPB Class II 2009-12-29
K090820 TRIA HAIR REMOVAL LASER SYSTEM Spectragenics, Inc. GEX Class II 2009-12-23
K093025 BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES Bovie Medical Corporation GEI Class II 2009-12-22
K092483 BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 C.R. Bard, Inc. GDW Class II 2009-12-18
K092344 LAC-MAC INNERBLOC LR SURGICAL GOWNS Lac Mac, Ltd. FYA Class II 2009-12-17
K091462 SPECTRA MEDICAL SAFETY SCAPEL Spectra, Inc. GDZ Class I 2009-12-15
K093691 ACCUMAX Boston Scientific Corp GEX Class II 2009-12-11
K092964 COOLTOUCH VARIA ND:YAG LASER SYSTEM New Star Lasers, Inc. GEX Class II 2009-12-11
K092032 BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 Davol Inc., Sub. C. R. Bard, Inc. FTL Class II 2009-12-08
K091746 WATERLASE MD, MODEL 7100102 Biolase Technology, Inc. GEX Class II 2009-12-07
K093166 WITTMANN PATCH Aperta, LLC FTL Class II 2009-12-07
K092482 TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 Shippert Medical Technologies Corp. MUU Class II 2009-12-04
K093165 ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS Arthrocare Corp. GEI Class II 2009-12-04
K091672 DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES Shuyou Electric Medical Science Co., Ltd. GEI Class II 2009-12-04
K092660 SIROLASER ADVANCE Sirona Dental Systems GmbH GEX Class II 2009-12-03
K092903 BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING Maquet GmbH and Co. KG BTA Class II 2009-12-01
K092634 OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF Jiangmen City Xinhui Baisheng Medical Equipment CO GEI Class II 2009-12-01
K091824 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 Ethicon Endo-Surgery, Inc. GEI Class II 2009-11-27
K093564 SVED WOUND TREATMENT SYSTEM Innovative Therapies, Inc. OMP Class II 2009-11-25
K092191 EXILIS, MODEL 5000 Btl Industries, Ltd. GEI Class II 2009-11-25
K092732 PROPENCIL ESU PENCIL Bio Protech, Inc. GEI Class II 2009-11-25
K092761 PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C Bio Protech, Inc. GEI Class II 2009-11-24
K083123 MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES Medart A/S GEX Class II 2009-11-24
K093451 OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP Omniguide, Inc. GEX Class II 2009-11-20
K092607 AJUST ADJUSTABLE SINGLE INCISION SLING C.R. Bard, Inc. PAH Class II 2009-11-20
K083754 MINI LAP ELECTROCAUTERY INSTRUMENTS Mini Lap Technologies, Inc. GEI Class II 2009-11-20
K090195 PALOMAR LUX1540 HANDPIECE Palomar Medical Technologies, Inc. GEX Class II 2009-11-20
K091664 GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C Shenzhen Gsd Tech Co., Ltd. ONF Class II 2009-11-16
K091061 IMPLICITGUIDE SURGICAL SUTURE SYSTEM Implicitcare, LLC GAT Class II 2009-11-13
K093253 AMID STAPLER Safestitch, LLC GDW Class II 2009-11-12

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