meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
36
Latest Decision
2006-03-09

Clearances · page 67 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060338 FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO Lumenis, Inc. GEX Class II 2006-03-09
K053442 BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE Regent Medical Americas, LLC KGO Class I 2006-03-07
K060181 COMPE1 1 -PLY SURGICAL GOWNS Standard Textile Co., Inc. FYA Class II 2006-03-07
K052953 NUVANCE* FACIAL REJUVENATION SYSTEM ETHICON, Inc. MXW Class II 2006-03-06
K060277 BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM Boehringer Laboratories JCX Class II 2006-03-03
K060069 PALOMAR LUXIR FRACTIONAL HANDPIECE Palomar Medical Technologies, Inc. GEX Class II 2006-03-02
K053087 VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM Biotex, Inc. GEX Class II 2006-03-01
K060400 CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT Medtronic, Inc. GEI Class II 2006-02-28
K060033 PROFILE MULTI-PLATFORM SYSTEM Sciton, Inc GEX Class II 2006-02-28
K060279 CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. GEH Class II 2006-02-28
K060046 DERMASTREAM Enzysurge , Ltd. NAD Class I 2006-02-27
K060395 CRYO, MODEL V6.0 Zimmer Elektromedizin GmbH GEX Class II 2006-02-24
K053364 HALUX IRIS EXAMINATION AND SURGICAL LAMP Waldmann Lighting FTD Class II 2006-02-23
K053412 FLEXISCOPE, MODELS 50MH AND 50 MHC Schoelly Imaging, Inc. FWF Class I 2006-02-23
K053604 WAVELIGHT IDAS Wavelight Laser Technologie AG GEX Class II 2006-02-22
K053424 POPMESH Caldera Medical, Inc. FTL Class II 2006-02-22
K060004 CALDERA MESH Caldera Medical, Inc. FTL Class II 2006-02-22
K060117 BOVIE BUTTON REMOTE HAND SWITCH Aaron Medical Industries GEI Class II 2006-02-22
K053139 FOTONA QX ND:YAG/KTP LASER SYSTEM Fotona D.D. GEX Class II 2006-02-16
K060170 ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS Erbe USA, Inc. GEI Class II 2006-02-16
K060183 ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER Erbe USA, Inc. GEI Class II 2006-02-16
K052833 GORE-TEX NON-STERILE SURGICAL GOWNS Medline Industries, Inc. KKX Class II 2006-02-15
K052797 LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM Medtek Devices, Inc. FYD Class II 2006-02-13
K060144 SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS Galil Medical , Ltd. GEH Class II 2006-02-13
K053608 CYNOSURE PHOTOGENICA V-STAR LASER Cynosure, Inc. GEX Class II 2006-02-13
K053627 MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING Kci USA, Inc. OMP Class II 2006-02-06
K053361 MODIFICATION TO: MINIMESH POLYPROPYLENE MESH Mpathy Medical Devices, Ltd. OTO Class II 2006-02-06
K042114 MDL SERIES DIODE LASERS, MODEL MDL-10/15 Vision Lasertechnik, GmbH GEX Class II 2006-02-03
K053655 TENDON WRAP TENDON PROTECTOR Integra LifeSciences Corporation FTM Class II 2006-02-03
K052796 COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES Valleylab GEI Class II 2006-02-03
K053371 AMS MALE TRANSOBTURATOR SLING SYSTEM American Medical Systems, Inc. OTM Class II 2006-02-03
K050516 T-SLING Herniamesh S.R.L. OTN Class II 2006-02-03
K052991 RADIANCY FACIAL SKINCARE DEVICE Radiancy (Israel) , Ltd. GEX Class II 2006-02-01
K053443 BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE Regent Medical Americas, LLC KGO Class I 2006-02-01
K053421 YAG MIR FAMILY LASER Cynosure, Inc. GEX Class II 2006-02-01
K053631 CONTOUR TRANSTAR CURVED CUTTER STAPLER SET Ethicon Endo-Surgery, Inc. GDW Class II 2006-01-30
K053518 INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR Medical Device Technologies, Inc. NEU Class II 2006-01-26
K052442 RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY Radiancy (Israel) , Ltd. GEX Class II 2006-01-26
K042096 MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM Misonix, Inc. NTB Class II 2006-01-26
K052680 CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. GEX Class II 2006-01-23
K060050 MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM Biolitec, Inc. GEX Class II 2006-01-23
K052830 SPORTMESH Artimplant AB FTL Class II 2006-01-19
K053433 CAUTERY TIP CLEANER, MODEL 30500 Xodus Medical, Inc. GEI Class II 2006-01-19
K053321 LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER Xodus Medical, Inc. FTA Class II 2006-01-19
K053158 OPTILENE MESH LP Aesculap, Inc. FTL Class II 2006-01-18
K053380 CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE Surgical Specialties Corp NEW Class II 2006-01-18
K053161 SIROLASER Sirona Dental Systems GmbH GEX Class II 2006-01-18
K052919 MICROSULIS TISSUE ABLATION SYSTEM Microsulis Americas, Inc. NEY Class II 2006-01-13
K053227 LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES Medical Illumination International, Inc. FST Class II 2006-01-13
K053436 SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE Cryocath Technologies, Inc. OCL Class II 2006-01-13
K050384 KAPP BARI-RING, MODEL KS-BR-2005 Kapp Surgical Instrument, Inc. NEU Class II 2006-01-13
K053326 ESTECH COBRA ELECTROSURGICAL UNIT & CABLE Endoscopic Technologies, Inc. GEI Class II 2006-01-06
K053324 CHROMOLITE SYSTEM Chromogenex Plc GEX Class II 2006-01-05
K053272 CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES Cardinalhealth KGO Class I 2006-01-05
K051113 QUANTA SYSTEM ETRNA GIOVINEZZA Quanta System Spa GEX Class II 2006-01-04
K052848 SPECTRA HAIR REMOVAL LASER Spectragenics, Inc. GEX Class II 2005-12-27
K053482 SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW Sutura, Inc. GAW Class II 2005-12-27
K053447 ARTHROCARE PERC-D SPINEWAND Arthrocare Corp. GEI Class II 2005-12-27
K052864 TYRX SURGICAL MESH, MODEL SMPC-0501 Tyrx Pharma, Inc. FTL Class II 2005-12-22
K053457 VAPORMAX II Trimedyne, Inc. GEX Class II 2005-12-21
K052772 BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES Barriermed Glove Co. KGO Class I 2005-12-20
K053100 ESTECH COBRA BIPOLAR SYSTEM Endoscopic Technologies, Inc. GEI Class II 2005-12-19
K053066 SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH Genzyme Corporation FTL Class II 2005-12-19
K053252 U-CLIP DEVICE, MODELS B140, B160 AND B180 Medtronic Vascular FZP Class II 2005-12-16
K052604 STARLITE 2006 Laser Dental Innovations GEX Class II 2005-12-16
K053296 MENTOR ARIS SUPRAPUBIC SURGICAL KIT Mentor Corporation OTN Class II 2005-12-15
K052259 DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 Schering-Plough Healthcare Products, Inc. GEH Class II 2005-12-14
K053365 MODIFICATION TO THERMAGE THERMACOOL SYSTEM Thermage, Inc. GEI Class II 2005-12-13
K052701 COROLENE Peters Surgical GAW Class II 2005-12-13
K053282 ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP Pajunk GmbH GEI Class II 2005-12-13
K052688 ELLIPSE FLEX PPT, MODEL 9ESF7255 Danish Dermatologic Development A/S GEX Class II 2005-12-12
K052177 POWDER FREE STERILE LATEX SURGICAL GLOVES Hartalega Sdn Bhd KGO Class I 2005-12-09
K053200 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. FTL Class II 2005-12-07
K053202 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. Gore & Associates FTL Class II 2005-12-07
K051371 INTERBODY INNOVATIONS CEMENT RESTRICTOR Interbody Innovations, Llp JDK Class II 2005-12-06
K053297 ARTHROCARE 8000S COBLATOR SURGERY SYSTEM Arthrocare Corp. GEI Class II 2005-12-06
K052962 OPTIMIZED BARB DESIGN Surgical Specialties Corp GAW Class II 2005-12-06
K050150 MANI NEEDLE & SUTURE PACK Mani, Inc. GAT Class II 2005-12-05
K052395 STERILE EQUIPMENT COVERS Volcano Corporation KKX Class II 2005-12-01
K053128 SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE Boston Scientific Corp GEI Class II 2005-11-30
K052401 GYNECARE TVT SECUR SYSTEM ETHICON, Inc. PAH Class II 2005-11-28
K052900 QUILL NONABSORBABLE NYLON BARBED SUTURE Quill Medical, Inc. GAR Class II 2005-11-28
K052874 SOPRANO HAIR REMOVAL DIODE LASER Msq (M2) , Ltd. GEX Class II 2005-11-22
K051836 SKELITE RESORBABLE CEMENT RESTRICTOR Millenium Biologix, Inc. JDK Class II 2005-11-21
K052837 SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA Terang Nusa Sdn Bhd KGO Class I 2005-11-21
K052702 MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY Misonix, Inc. GEI Class II 2005-11-21
K052530 SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA Galil Medical , Ltd. GEH Class II 2005-11-18
K051330 UVBIOTEK MODELS 3200B AND 4000B Medtek Lighting Corporation FTC Class II 2005-11-18
K052169 IMC SURGICAL DRAPES International Medsurg Connection, Inc. KKX Class II 2005-11-17
K052550 IMC SURGICAL GOWNS Intl. Medsurg Connection, Inc. FYA Class II 2005-11-17
K052861 MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 Sanarus Medical, Inc. GEH Class II 2005-11-15
K052526 NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES Lumenis, Inc. GEX Class II 2005-11-15
K040832 C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 Cardica, Inc. FZP Class II 2005-11-10
K050550 GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR Gyrus Medical, Inc. GEI Class II 2005-11-09
K052437 MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE Surgical Specialties Corp GAM Class II 2005-11-07
K052910 POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS Power Medical Interventions, Inc. GDW Class II 2005-11-07
K052018 MILTEX LIGATING CLIP Miltex, Inc. FZP Class II 2005-11-04
K052456 MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM Blue Sky Medical Group Incorporated OMP Class II 2005-11-04
K052650 PIONEER U601 SERIES ASPIRATOR Merits Health Products Co., Ltd. BTA Class II 2005-11-04
K052770 PATHFORMER Path Scientific, LLC NWF Class I 2005-10-31

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