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
2007-02-09

Clearances · page 64 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063571 PALOMAR LUX2940 HANDPIECE Palomar Medical Technologies, Inc. GEX Class II 2007-02-09
K063778 FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE Teleflex Medical GAT Class II 2007-02-09
K063682 INTRALASE FUSION LASER Intra Lase Corp. GEX Class II 2007-02-09
DEN060003 TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. NWJ Class II 2007-02-08
K063603 SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 Suturtek Incorporated GAQ Class II 2007-02-07
K063715 JUNIPER COOLING DEVICE XTRA Juniper Medical, Inc. GEX Class II 2007-02-05
K061919 VERSATILE 1 EZCARE WOUND VACUUM SYSTEM Blue Sky Medical Group Incorporated OMP Class II 2007-02-05
K063800 CANDELA FLUORESCENT PULSED LIGHT SYSTEM Candela Corp. GEX Class II 2007-02-05
K070078 STRYKER T4 HYTREL TOGA Stryker Instruments, Instruments Div. FYA Class II 2007-02-02
K070157 OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER Omniguide, Inc. GEX Class II 2007-02-01
K061445 SURGIMESH WN Aspide Medical FTL Class II 2007-02-01
K063748 THERMOMED 1.8 Thermosurgery Technologies, Inc. GEI Class II 2007-02-01
K062303 FRAXEL II SR LASER SYSTEM Reliant Technologies, Inc. GEX Class II 2007-01-31
K062511 AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX Alveolus, Inc. JCT Class II 2007-01-31
K061720 COSMELIGHT Penntack Enterprises, Inc. GEX Class II 2007-01-31
K063238 ULTRACLIP II WING AND ULTRACLIP II COIL Inrad NEU Class II 2007-01-30
K070063 YAG MIR II LASER Cynosure, Inc. GEX Class II 2007-01-30
K070165 ENSEAL PTC TRIO Surgrx, Inc. GEI Class II 2007-01-29
K063536 POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING Tyco Healthcare Group GAM Class II 2007-01-29
K061898 EZLASE Biolase Technology, Inc. GEX Class II 2007-01-26
K063630 ATRICURE ABLATION SYSTEM AtriCure, Inc. GEI Class II 2007-01-26
K062528 TISSUE SITE MARKING SYSTEM Suros Surgical Systems, Inc. NEU Class II 2007-01-26
K062712 ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 Erbe USA, Inc. GEI Class II 2007-01-26
K062899 MICROTEK MEDICAL SURGICAL GOWN/TOGA Microtek Medical, Inc. FYA Class II 2007-01-25
K063828 DIOMED DELTA 25 Diomed, Ltd. GEX Class II 2007-01-25
K070071 OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER Omniguide, Inc. GEX Class II 2007-01-25
K062082 CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 Conmed Corporation GEI Class II 2007-01-25
K063834 REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM Hoya Conbio, Inc. GEX Class II 2007-01-25
K063590 V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 Kci USA, Inc. OMP Class II 2007-01-25
K063235 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT Cytori Therapeutics, Inc. QPB Class II 2007-01-24
K060465 PREMIO Peters Surgical MXW Class II 2007-01-17
K063249 BEAMAX Medic Sharplight , Ltd. GEX Class II 2007-01-17
K063396 VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES Lasering S.R.L. GEX Class II 2007-01-17
K063621 3 SERIES PHOTOTHERAPY CABINET Daavlin Co. FTC Class II 2007-01-17
K063739 SEPRAMESH, MODEL 5959-1214 Genzyme Corporation FTL Class II 2007-01-17
K062363 BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM B&W Tek, Inc. GEX Class II 2007-01-17
K063688 SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE The Anspach Effort, Inc. HWE Class I 2007-01-16
K063747 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A Inovel, LLC MSH Class II 2007-01-12
K063462 NEATSTITCH NEATCLOSE SUTURING DEVICE Neat Stitch , Ltd. GAM Class II 2007-01-12
K063746 POWER EXTENDERS MODEL# PEC200, PES200,PES200S Power Medical Interventions, Inc. GDW Class II 2007-01-12
K063644 CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. FZP Class II 2007-01-11
K062907 ALEXIS WOUND RETRACTOR Applied Medical Resources KGW Class II 2007-01-09
K062896 V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 Sanarus Medical, Inc. GEH Class II 2007-01-03
K063074 CANDELA 3630 LASER SYSTEM Candela Corp. GEX Class II 2006-12-27
K062314 HORUS LASER KERATOME Carl Zeiss Meditec, AG GEX Class II 2006-12-22
K060346 ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM Ultrazonix Dnt AB NTB Class II 2006-12-22
K062950 POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) Hartalega Sdn Bhd KGO Class I 2006-12-21
K062847 BIOGEL ECLIPSE INDICATOR UNDERGLOVE Molnlycke Health Care Us, LLC KGO Class I 2006-12-20
K063072 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES Candela Corp. GEX Class II 2006-12-20
K063073 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS Candela Corp. GEX Class II 2006-12-20
K063136 NEEDLELESS SLING Specialities Remeex International, S.L. PAH Class II 2006-12-19
K062821 U-CLIP DEVICE Medtronic Neurosurgery FZP Class II 2006-12-19
K061656 LASER-D68 Laser Pain Clinics LP GEX Class II 2006-12-15
K062969 MEDLINE STERILE DISPOSABLE SURGICAL GOWNS Medline Industries, Inc. FYA Class II 2006-12-14
K063426 V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 Kci USA, Inc. OMP Class II 2006-12-13
K061533 PROCEED VENTRAL PATCH ETHICON, Inc. FTL Class II 2006-12-11
K063334 SHANGHAI GANGHAI MODEL GIKO 1400 Shanghai Gangkai Purifying Products Co., Ltd. MSH Class II 2006-12-08
K060839 ABC HAIR REMOVAL SYSTEM Palomar Medical Technologies, Inc. OHT Class II 2006-12-07
K062915 VERITAS COLLAGEN MATRIX Synovis Surgical Innovations FTM Class II 2006-12-06
K061276 G-PROX ENDOSCOPIC GRASPER Usgi Medical GAT Class II 2006-12-06
K061436 PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM Palomar Medical Technologies, Inc. GEX Class II 2006-12-06
K062750 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 Boston Scientific Corp MUM Class II 2006-12-04
K063194 TUFFLEX POLYESTER SUTURE Axya Medical, Inc. GAT Class II 2006-12-04
K063013 PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S Aearo Company MSH Class II 2006-12-01
K063538 ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS Arthrocare Corp. GEI Class II 2006-12-01
K063012 NCONTACT COAGULATION SYSTEM KIT, MODEL CSK Ncontact Surgical, Inc. OCL Class II 2006-12-01
K062719 GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES Laserscope GEX Class II 2006-12-01
K063112 REVLITE Q-SWITCHED ND:YAG LASER Hoya Conbio, Inc. GEX Class II 2006-12-01
K063025 LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, Lina Medical Aps GEI Class II 2006-12-01
K063485 LOGIC LAPAROSCOPIC SCISSORS Surgical Innovations Plc GEI Class II 2006-12-01
K062539 NCONTACT COAGULATION SYSTEM KIT Ncontact Surgical, Inc. GEI Class II 2006-12-01
K063448 EMG AC/DC SUCTION UNIT Emg Technology Co., Ltd. JCX Class II 2006-11-30
K062589 SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM Inolase 2002, Ltd. GEX Class II 2006-11-30
K063195 LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 Valleylab GEI Class II 2006-11-29
K063060 BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP Blueshine Srl GEX Class II 2006-11-29
K063141 OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER Omniguide, Inc. GEX Class II 2006-11-29
K063435 GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL W. L. Gore & Associates, Inc. FTL Class II 2006-11-28
K061892 PROPATCH SOFT TISSUE REPAIR MATRIX Cryolife, Inc. FTM Class II 2006-11-22
K062721 GREENTON ECOLITE IPL SYSTEM Greenton (London) , Ltd. GEX Class II 2006-11-21
K063333 M3 Mavig GmbH FSY Class II 2006-11-21
K063193 MODIFICATION TO BIOMARC TISSUE MARKER Carbon Medical Technologies, Inc. NEU Class II 2006-11-21
K060054 ONCOBIONIC SYSTEM Oncobionics, Inc. OAB Class II 2006-11-21
K062822 VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 Vascular Solutions, Inc. GEX Class II 2006-11-21
K063161 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL Leonhard Lang GmbH GEI Class II 2006-11-21
K063178 BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 C.R. Bard, Inc. FTM Class II 2006-11-21
K061375 RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 Louis M. Gerson Co., Inc. MSH Class II 2006-11-17
K061829 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES New Leaf Medical, Inc. GEI Class II 2006-11-17
K053524 C-PORT DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. FZP Class II 2006-11-16
K062441 BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 Barrx Medical, Incorporated GEI Class II 2006-11-14
K062871 LUMACARE LC-122M NON-COHERENT LIGHT SOURCE Lynton Lasers Limited GEX Class II 2006-11-14
K062619 DENLASER 800 PLUS CAO Group, Inc. GEX Class II 2006-11-14
K062723 HALO90 COAGULATION CATHETER Barrx Medical, Incorporated GEI Class II 2006-11-09
K062369 IRIDEX OCULIGHT TX Iridex Corp GEX Class II 2006-11-08
K063079 I-STOP TRANS OBTURATOR MALE SLING Cl Medical OTM Class II 2006-11-07
K062914 HEM-O-LOK LIGATION CLIP Teleflex Medical FZP Class II 2006-11-02
K062341 MALE REMEEX SYSTEM Specialities Remeex International, S.L. OTM Class II 2006-11-02
K061288 AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER United States Surgical, A Division of Tyco Healthc FZP Class II 2006-11-02
K063075 NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS Power Medical Interventions, Inc. GDW Class II 2006-11-02
K061796 HEPATOSTAT SET, MODEL 760X Vygon Corp. GAM Class II 2006-11-02
K062321 SMARTLIPO ND:YAG LASER Cynosure, Inc. GEX Class II 2006-10-31

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