meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
30
Latest Decision
2001-05-18

Clearances · page 82 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K010672 MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE Gramsmed, LLC GAM Class II 2001-05-18
K010689 MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM Biolitec, Inc. GEX Class II 2001-05-18
K010710 SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES Seedling Enterprises., LLC GEI Class II 2001-05-18
K011236 MODIFICATION TO IMPLANTABLE CLIP Applied Medical Resources Corp. FZP Class II 2001-05-14
K010465 DENSTAT Elmed, Inc. GEI Class II 2001-05-14
K010673 ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 Arthrex, Inc. GAT Class II 2001-05-14
K002639 BIOKNOTLESS ANCHOR Mitek Products GAM Class II 2001-05-11
K010666 XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE Medtronic Xomed, Inc. QPB Class II 2001-05-07
K003403 ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 Highland / Marietta, Inc. JOS Class II 2001-05-07
K010661 MODIFICATION TO TISSUELINK BIPOLAR FORCEPS Tissuelink Medical, Inc. GEI Class II 2001-05-03
K010487 BIPOLAR PENCIL, MODEL 3901-002, 3900-002 Medtronic PS Medical GEI Class II 2001-05-03
K010348 TANTALUM BEADS - RADIOGRAPHIC MARKER Biomet, Inc. NEU Class II 2001-05-03
K001807 TISSUE MARKER Advanced Uroscience, Inc. GDW Class II 2001-05-03
K010991 SEEDNET, MODELS FP6T5, FP5T5, FP5T3 Galil Medical , Ltd. GEH Class II 2001-05-03
K010438 MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) Terang Nusa Sdn Bhd KGO Class I 2001-05-01
K010439 MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) Terang Nusa Sdn Bhd KGO Class I 2001-05-01
K010284 LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) Laserscope GEX Class II 2001-05-01
K010316 COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM Cooltouch Corp. GEX Class II 2001-05-01
K010722 PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, Inc. FTL Class II 2001-04-27
K010662 MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL Tissuelink Medical, Inc. GEI Class II 2001-04-27
K010245 ACTIVHEAL SCAR MANAGEMENT DRESSING Advanced Medical Solutions, Ltd. MDA Class I 2001-04-25
K000442 ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX Medical Concepts Development, Inc. KKX Class II 2001-04-24
K003440 SOFTLASE - SURGICAL DIODE LASER SYSTEM Zap Lasers, Inc. GEX Class II 2001-04-20
K010840 SYNPLUG Isotis NV LZN Class II 2001-04-20
K010956 COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X Boston Scientific Corp GEI Class II 2001-04-13
K010113 LASER MECHANISMS LASER SCANNING SYSTEM Laser Mechanisms, Inc. GEX Class II 2001-04-12
K003126 BIPOLAR TRIGGER-FLEX PROBE Ellman Intl., Inc. GEI Class II 2001-04-11
K010104 CANDELA LONG PULSE ND:YAG Candela Corp. GEX Class II 2001-04-11
K002000 MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; Richard Wolf Medical Instruments Corp. GEI Class II 2001-04-10
K003676 RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR Rita Medical Systems GEI Class II 2001-04-09
K010265 BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 Baylis Medical Co., Inc. GEI Class II 2001-04-09
K010909 NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE Tyco Healthcare Group LP GAW Class II 2001-04-09
K010931 AMS SACRAL COLPOPEXY SLING, MODEL 72403501 American Medical Systems, Inc. OTO Class II 2001-04-09
K002981 ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 Ethicon Endo-Surgery, Inc. GEI Class II 2001-04-09
K010046 NUVOLASE 532 MEDICAL LASER SYSTEM American Laser Corp. GEX Class II 2001-04-05
K010035 IVS TUNNELLER United States Surgical, A Division of Tyco Healthc FTL Class II 2001-04-04
K001892 WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) White Knight Healthcare, Inc. FXX Class II 2001-04-03
K010112 BIPOLAR COAGULATION SYSTEM Enable Medical Corp. GEI Class II 2001-04-02
K010010 VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR Valleylab, Inc. GEI Class II 2001-04-02
K010192 ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION Antyllos Medizintechnik GmbH GEI Class II 2001-04-02
K010005 CYNOSURE PHOTOGENICA DL Cynosure, Inc. GEX Class II 2001-04-02
K001997 WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS) White Knight Healthcare, Inc. FXX Class II 2001-04-02
K001893 WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) White Knight Healthcare, Inc. FXX Class II 2001-04-02
K004039 CYNOSURE PHOTOGENICA NEO-V Cynosure, Inc. GEX Class II 2001-03-29
K004021 F1 DIODE LASER SYSTEM Opus Medical, Inc. GEX Class II 2001-03-27
K003993 DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) Dornier Surgical Products, Inc. GEX Class II 2001-03-26
K010277 AMS FASCIAL-ANCHORING SYSTEM American Medical Systems, Inc. NEH Class II 2001-03-26
K010013 LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 Valleylab, Inc. GEI Class II 2001-03-26
K004006 SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER Lumenis, Inc. GEX Class II 2001-03-26
K003897 ENDIUS BIPOLAR SHEATH Endius, Inc. GEI Class II 2001-03-22
K010589 MICROWAVAE DELIVERY SYSTEM #MW2000 Mw Medical, Inc. MWY Class II 2001-03-19
K003979 MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD Medtrade Products , Ltd. MDA Class I 2001-03-19
K003965 MRI SAFE INSTRUMENTS Aesculap, Inc. GEA Class I 2001-03-16
K003953 INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 Ethicon Endo-Surgery, Inc. GEX Class II 2001-03-16
K004014 MD 30 COMPACT General Project GEX Class II 2001-03-16
K003952 INDIGO LASEROPTIC TREATMENT SYSTEM Ethicon Endo-Surgery, Inc. GEX Class II 2001-03-16
K003955 LASEREX INTEGRE, MODEL LP2532 Ellex Medical Pty, Ltd. GEX Class II 2001-03-15
K002315 WISEBANDS SKIN CLOSURE DEVICE Wisebands , Ltd. MKY Class I 2001-03-15
K003173 ASPIRE COVERED STENT AND DELIVERY CATHETER Vascular Architects, Inc. ESW Class II 2001-03-13
K003614 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM Coherent Star GEX Class II 2001-03-13
K003017 GRAMSORB SYNTHETIC ABSORBABLE SUTURE Gramsmed, LLC GAM Class II 2001-03-13
K010572 BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE Becton, Dickinson and Co. KKX Class II 2001-03-12
K010041 SLT DIFFUSER FIBER Surgical Laser Technologies, Inc. GEX Class II 2001-03-07
K003765 LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) Laserscope GEX Class II 2001-03-06
K003777 CARIS SITE MARKER Artemis Medical, Inc. FZP Class II 2001-03-06
K003590 GRAMS POLYESTER NONABSORBABLE SUTURE Gramsmed, LLC GAT Class II 2001-03-05
K003886 PALOMAR SPALIGHT PULSED LIGHT SYSTEM Palomar Medical Technologies, Inc. GEX Class II 2001-03-01
K003715 COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II Cooltouch Corp. GEX Class II 2001-03-01
K010285 CONTOUR PROFILE LASER Sciton, Inc GEX Class II 2001-03-01
K003705 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 Photo Medex, Inc. GEX Class II 2001-03-01
K003717 INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF Tekno Medical Optik-Chirurgie GmbH & Co. GEI Class II 2001-03-01
K010444 ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP C.R. Bard, Inc. GEI Class II 2001-02-28
K003749 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN Banta Healthcare FYC Class II 2001-02-23
K010198 STERILE POWDERED LATEX SURGEON GLOVES Supermax Glove Manufacturing Sdn Bhd KGO Class I 2001-02-23
K003423 ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 St. Francis Medical Equipment Co., Ltd. FTD Class II 2001-02-22
K010025 ELECTRICATOR MODEL 26000 Dermatologic Lab & Supply, Inc. GEI Class II 2001-02-22
K003885 VISULAS YAG II Carl Zeiss, Inc. GEX Class II 2001-02-22
K010228 GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. FTL Class II 2001-02-21
K010210 CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 Curon Medical, Inc. GEI Class II 2001-02-21
K003755 MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES Medline Industries, Inc. FYA Class II 2001-02-16
K002699 PARIETEX COMPOSITE (PCO) MESH Medical Device Consultants, Inc. FTL Class II 2001-02-15
K003718 TITANIUM CEMENT RESTRICTOR (TCR) Medtronic Sofamor Danek, Inc. JDK Class II 2001-02-14
K003522 SALUTE Onux Medical, Inc. GDW Class II 2001-02-13
K010068 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM Rusch Intl. ESW Class II 2001-02-08
K003958 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE Coalescent Surgical FZP Class II 2001-02-06
K002877 MICTEC ENDOSCOPES AND ACCESSORIES Dufner Instrumente GmbH GEI Class II 2001-02-05
K003489 NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 Medical Illumination International, Inc. FSS Class II 2001-02-02
K003773 CLEAN SCRAPE Webb Research Ii, Inc. GEI Class II 2001-02-02
K003840 CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES I.C Medical, Inc. FYD Class II 2001-02-01
K003577 STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT STERIS Corporation FST Class II 2001-01-29
K003948 EPI-DERM SILICONE GEL SHEETING Biodermis Corp. MDA Class I 2001-01-29
K003906 MODIFICATION TO FLUROTEX SURGICAL MESH Bridger Biomed, Inc. FTL Class II 2001-01-26
K003670 PATIENT DRAPE, SURGICAL Advance Medical Designs, Inc. KKX Class II 2001-01-26
K003917 MODIFICATION TO FLUOROTEX II SURGICAL MESH Bridger Biomed, Inc. FTL Class II 2001-01-26
K003460 PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM Palomar Medical Technologies, Inc. GEX Class II 2001-01-25
K003541 DENLASER, MODEL 800 CAO Group, Inc. GEX Class II 2001-01-25
K003385 TWILITE, TWILITE WHITE Biolase Technology, Inc. GEX Class II 2001-01-25
K003990 SOFRADIM PARIETEX SURGICAL MESHES Sofradim Production FTL Class II 2001-01-24
K010060 RITA STARBURST XLI ELECTROSURGICAL DEVICE Rita Medical Systems GEI Class II 2001-01-23
K003323 COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 Davol, Inc. FTL Class II 2001-01-22

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