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
2005-07-05

Clearances · page 69 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050841 FRAXEL SR LASER SYSTEM Reliant Technologies, Inc. GEX Class II 2005-07-05
K041653 COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS Standard Textile Co., Inc. FYA Class II 2005-07-01
K051255 LUMIPHASE-R Opusmed, Inc. GEX Class II 2005-07-01
K051399 WAVELIGHT AURIGA Wavelight Laser Technologie AG GEX Class II 2005-06-30
K051168 BARRX HALO 360 SYSTEM, MODEL 1100C-115A Barrx Medical, Incorporated GEI Class II 2005-06-29
K050845 MONOCRYL PLUS ANTIBACTERIAL SUTURE ETHICON, Inc. GAM Class II 2005-06-29
K042630 REVLIGHT SKIN CARE SYSTEM Skincare Technology, Inc. GEX Class II 2005-06-27
K050779 CYNERGY MULTIPLEX LASER Cynosure, Inc. GEX Class II 2005-06-27
K051415 ENDOTINE RIBBON Coapt Systems, Inc. GAM Class II 2005-06-23
K051563 NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED Terang Nusa Sdn Bhd KGO Class I 2005-06-20
K050696 MEDLITE C1 Q-SWITCHED ND:YAG LASER Hoya Photonics, Inc. GEX Class II 2005-06-17
K050445 AMS COLLAGEN DERMAL MATRIX American Medical Systems, Inc. PAG Class II 2005-06-17
K050156 WHS-1000 WOUND HEALING SYSTEM Iyia Technologies, Inc. KPJ Class II 2005-06-17
K041382 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE Osteobiologics, Inc. JDK Class II 2005-06-17
K051245 POLYFORM SYNTHETIC MESH Proxy Biomedical , Ltd. OTO Class II 2005-06-17
K050459 ATRICURE ISOLATOR TRANSPOLAR PEN AtriCure, Inc. OCL Class II 2005-06-13
K050673 CANDELA FAMILY OF PULSE DYE LASER SYSTEMS Candela Corp. GEX Class II 2005-06-13
K051190 XENFORM SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc. PAJ Class II 2005-06-10
K050397 VELASMOOTH, SHAPER Syneron Medical, Ltd. NUV Class II 2005-06-09
K051125 IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 Abbott Laboratories FZP Class II 2005-06-08
K050538 IMC DRAPES Intl. Medsurg Connection, Inc. KKX Class II 2005-06-07
K051094 NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE Terang Nusa Sdn Bhd KGO Class I 2005-06-06
K041514 TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE Sutures India Private Limited GAP Class II 2005-06-03
K041511 TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE Sutures India Private Limited GAW Class II 2005-06-03
K050738 FT FIBER OPTIC DELIVERY SYSTEMS Fibertech GmbH GEX Class II 2005-06-02
K041510 TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE Sutures India Private Limited GAR Class II 2005-06-02
K041512 NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE Sutures India Private Limited GAT Class II 2005-06-02
K050947 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE United States Surgical, A Division of Tyco Healthc GAW Class II 2005-06-01
K043377 ZENO Tyrell, Inc. GEX Class II 2005-06-01
K051167 REVOLIX AND REVOLIX JR Allmed Systems, Inc. GEX Class II 2005-06-01
K042606 MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE Synthes (Usa) GAQ Class II 2005-05-27
K050332 SURGI-WRAP MAST BIORESORBABLE SHEET Mast Biosurgery USA, Inc. FTL Class II 2005-05-27
K043198 VANGUARD REPROCESSED ARTHROSCOPIC WANDS Vanguard Medical Concepts, Inc. NUJ Class II 2005-05-27
K050453 ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 Ivoclar Vivadent, Inc. GEX Class II 2005-05-27
K050766 EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM Zimmer Trabecular HWE Class I 2005-05-26
K050261 V.A.C. GRANUFOAM SILVER PROTECTION DRESSING Kinetic Concepts, Inc. OMP Class II 2005-05-26
K043234 LIGHT DRAPE Wrapped IN Comfort MMP Class II 2005-05-25
K050610 SALUTE FIXATION SYSTEM Davol Inc., Sub. C. R. Bard, Inc. GDW Class II 2005-05-25
K050898 SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX Smith & Nephew, Inc. GEI Class II 2005-05-25
K050678 MOTIFMESH SOFT TISSUE PATCH Proxy Biomedical , Ltd. FTL Class II 2005-05-20
K051182 INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Inovel, LLC MSH Class II 2005-05-19
K050246 SIS DERMAL AUGMENTATION STRAND Cook Biotech, Inc. FTM Class II 2005-05-19
K050923 LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR Conmed Linvatec JOS Class II 2005-05-18
K050957 EUTROCHAR Special Devices, Inc. MDM Class I 2005-05-18
K050129 CELLERATION MIST THERAPY SYSTEM 5.1 Celleration, Inc. NRB Class II 2005-05-17
K051002 ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER Ethicon Endo-Surgery, Inc. GDW Class II 2005-05-17
K050519 ADVANCED TURBO DRIVE SYSTEM Linvatec Corp. GEY Class I 2005-05-17
K050322 MICROTEK EQUIPMENT DRAPES Microtek Medical, Inc. KKX Class II 2005-05-17
K043191 REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH Angiologica B. M. Srl FTL Class II 2005-05-16
K050900 MEDIOSTAR XT Asclepion Laser Technologies GmbH GEX Class II 2005-05-16
K043330 POLYPROPILENE SURGICAL SUTURES Demetech Corp. GAW Class II 2005-05-16
K050418 TISSUE FIXATION SYSTEM Tfs Manufacturing Pty, Ltd. FTL Class II 2005-05-16
K050071 MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE H.B.M. USA Co.,Inc. KGO Class I 2005-05-11
K042977 LASIK EYE DRAPE Odyssey Medical, Inc. KKX Class II 2005-05-10
K042534 MARINA MEDICAL FINGER PROTECTORS Marina Medical Instruments, Inc. KGO Class I 2005-05-10
K050786 BARRIER SURGICAL GOWNS Molnlycke Health Care FYA Class II 2005-05-09
K051052 SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) Galil Medical , Ltd. GEH Class II 2005-05-06
K050814 ATRIUM ICAST COVERED STENT Atrium Medical Corp. JCT Class II 2005-05-06
K043036 NON-STICK ELECTRODE Modern Medical Equipment Mfg., Ltd. GEI Class II 2005-05-06
K050080 CYNOSUREA ECLILITE AND ECLILITE U Cynosure, Inc. FTC Class II 2005-05-05
K050356 COMPRESSION ANASTOMOSIS RING (CAR) Niti Medical Technologies , Ltd. FZP Class II 2005-05-05
K041540 COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS Standard Textile Co., Inc. FYA Class II 2005-05-05
K050672 ERCHONIA EVRL LASER Erchonia Medical, Inc. GEX Class II 2005-05-02
K050656 AMSINO SUTURE REMOVAL KIT Amsino International, Inc. MCZ Class I 2005-05-02
K050274 DIODENT II DENTAL LASER SYSTEM Hoya Photonics, Inc. GEX Class II 2005-04-29
K050950 MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS Active Optical Systems, Ltd./Efraim Bidas GEX Class II 2005-04-29
K041648 NITI-S STENT & INTRODUCER, MODEL EOXXXX Taewoong Medical Co., Ltd. ESW Class II 2005-04-28
K041539 COMPEL SURGICAL GOWNS Standard Textile Co., Inc. FYA Class II 2005-04-28
K041554 AIP INTENSE PULSED LIGHT SYSTEM Aesthera Corporation GEX Class II 2005-04-27
K050340 MICROMEDICS SPHENOID SINUS STENT Micromedics, Inc. KAM Class I 2005-04-27
K050508 HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES Haywood Vocational Opportunities KKX Class II 2005-04-27
K050256 APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR Apple Medical Corp. GAD Class I 2005-04-26
K050533 ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE Regent Medical Americas, LLC KGO Class I 2005-04-26
K042526 DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX Medical Action Industries, Inc. KKX Class II 2005-04-25
K050165 MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 Cyden Limited GEX Class II 2005-04-19
K050695 FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT Daavlin Distributing Co. FTC Class II 2005-04-19
K050699 MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 Amedica Corp. JDK Class II 2005-04-15
K043250 STRYKER PATIENT SPECIFIC POLYMER IMPLANT Stryker Leibinger KKY Class II 2005-04-15
K050254 SPECTRA-SP CO2 LASER SYSTEM Max Engineering , Ltd. GEX Class II 2005-04-15
K050562 OCULIGHT GL/GLX Iridex Corp GEX Class II 2005-04-14
K050181 MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES Medigloves , Ltd. KGO Class I 2005-04-13
K050831 STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A Stellartech Research Corp. GEI Class II 2005-04-12
K050796 AURORA DS, DS APPLICATOR Syneron Medical, Ltd. GEX Class II 2005-04-12
K050193 GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR Louis M. Gerson Co., Inc. MSH Class II 2005-04-11
K041515 TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE Sutures India Private Limited GAM Class II 2005-04-08
K050771 LUPINE LOOP Depuy Mitek, A Johnson & Johnson Company GAM Class II 2005-04-08
K042710 SURGITRON RADIOLASE II Ellman Int'L, Inc. GEI Class II 2005-04-07
K050611 ENDOTINE RIBBON Coapt Systems, Inc. GAM Class II 2005-04-06
K043539 DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES Demetech Corp. GAM Class II 2005-04-06
K050671 ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM Surgrx, Inc. GEI Class II 2005-04-01
K050548 CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS Surgical Specialties Corp GAW Class II 2005-04-01
K050047 CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY Cutera, Inc. GEX Class II 2005-03-31
K050679 CUTERA SOLERA OPUS AESTHETIC PRODUCT Cutera, Inc. GEX Class II 2005-03-31
K043515 GRAFTSAVER Vescare, Inc. GBX Class I 2005-03-31
K050737 NEOTHERMIA EN-BLOC BIOPSY SYSTEM Neothermia Corporation GEI Class II 2005-03-31
K050579 MEGA POWER ELECTROSURGICAL GENERATOR Megadyne Medical Products, Inc. GEI Class II 2005-03-24
K043521 BIOSYAG 50 MED Bios S.R.L. GEX Class II 2005-03-24
K043063 OXYBAND WOUND DRESSING Oxyband Technologies, Inc. NAD Class I 2005-03-24
K050021 VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT Vascular Solutions, Inc. GEX Class II 2005-03-18
K050293 FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS Fotona D.D. GEX Class II 2005-03-18

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