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
2006-07-10

Clearances · page 66 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K061366 DENLASER 800 PLUS CAO Group, Inc. GEX Class II 2006-07-10
K060448 LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. Lumenis, Ltd. GEX Class II 2006-07-06
K052354 OCULASE MD Biolase Technology, Inc. GEX Class II 2006-07-05
K053406 BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES Barriermed Glove Co. KGO Class I 2006-07-05
K061386 ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB Anulex Technologies, Inc. GAT Class II 2006-07-05
K061156 ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS Ethicon Endo-Surgery, Inc. GDW Class II 2006-07-03
K061603 SMOOTHSHAPES Biocellulase, Inc. NUV Class II 2006-07-03
K060494 EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM Medchannel, LLC GDW Class II 2006-07-03
K061174 SURGI-MAX Ellman Int'L, Inc. GEI Class II 2006-06-28
K060030 THE DOUBLE GLOVE Biobarrier, Inc. KGO Class I 2006-06-27
K053562 ZIMMER COLLAGEN REPAIR PATCH Tissue Science Laboratories, Plc FTM Class II 2006-06-23
K061038 BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 Barriermed Glove Co. KGO Class I 2006-06-23
K061317 ILED Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg FSY Class II 2006-06-22
K061205 MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR Medela AG BTA Class II 2006-06-21
K061117 NANOLITE SKIN CARE SYSTEM Nanolite Technology, Inc. GEX Class II 2006-06-20
K061526 ENSEAL PTC TISSUE SEALING DEVICE Surgrx, Inc. GEI Class II 2006-06-15
K052759 DAN MONOPOLAR LAP ACCESSORIES Dannoritzer Medizintechnik GmbH & Co. KG GEI Class II 2006-06-14
K061178 ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2006-06-12
K061435 MEDELA VARIO SUCTION PUMPS Medela AG OMP Class II 2006-06-08
K053464 SERVICE MANAGER SM40SE Conmed Integrated Systems, Canada, Ulc FYD Class II 2006-06-06
K061308 TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N Cardinal Health 200, Inc. FYA Class II 2006-06-05
K060721 LARIAT LOOP APPLICATOR Sentreheart GAT Class II 2006-06-02
K061314 BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH Davol Inc., Sub. C. R. Bard, Inc. FTL Class II 2006-06-02
K060905 IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 Iridex Corp GEX Class II 2006-05-31
K061095 AUTO SUTUR ENDO GIA STAPLERS United States Surgical, A Division of Tyco Healthc GDW Class II 2006-05-31
K060407 JUNIPER COOLING DEVICE Juniper Medical Technology, Inc. GEX Class II 2006-05-31
K060200 MICROTEK MEDICAL WARMING DRAPE Microtek Medical, Inc. KKX Class II 2006-05-31
K060713 PROCEED SURGICAL MESH ETHICON, Inc. FTL Class II 2006-05-25
K061295 VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 Theralight, Inc. FTC Class II 2006-05-25
K060752 ACMI DUR-HL LASER SYSTEMS Acmi Corporation GEX Class II 2006-05-25
K060776 SURGICAL FACE MASK Hong YA Non-Woven Products Co., Ltd. FXX Class II 2006-05-25
K051442 PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT Cynosure, Inc. GEX Class II 2006-05-24
K060977 MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 Hoya Conbio, Inc. GEX Class II 2006-05-24
K060928 CRYOSHAPE Etgar Group H.M.Y.A. , Ltd. GEH Class II 2006-05-22
K053637 MANI NEEDLE & SUTURE PACK (NYLON) Mani, Inc. GAR Class II 2006-05-19
K053638 MANI NEEDLE & SUTURE PACK (SILK) Mani, Inc. GAP Class II 2006-05-19
K061258 TRABECTOME HIGH FREQUENCY GENERATOR/LP Neomedix Corp. GEI Class II 2006-05-18
K061259 MODIFICATION TO ARTHROCARE PERC-D SPINEWAND Arthrocare Corp. GEI Class II 2006-05-18
K060984 XENFORM SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc. FTM Class II 2006-05-17
K060829 COSMATRIX Tei Biosciences, Inc. FTM Class II 2006-05-17
K060801 DEKNA-LOK MODEL BP1000V2L Teleflex Medical GAM Class II 2006-05-17
K060715 MODIFICATION TO: CARDIMA ABLATION SYSTEM Cardima, Inc. OCL Class II 2006-05-15
K060989 TISSUEMEND SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc. FTM Class II 2006-05-15
K060516 ELLIPSE 12PL, MODEL 9ESL7228 Danish Dermatologic Development A/S GEX Class II 2006-05-15
K060323 ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 Boston Scientific Corporation MQR Class II 2006-05-12
K052690 SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS Suretek Medical NUJ Class II 2006-05-12
K060247 LIFE SPINE CEMENT RESTRICTOR Life Spine JDK Class II 2006-05-11
K052695 SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS Suretek Medical NUJ Class II 2006-05-10
K052692 SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES Suretek Medical NUJ Class II 2006-05-10
K061030 BIOBLANKET SURGICAL MESH Kensey Nash Corporation FTM Class II 2006-05-09
K060974 RELIENT NAVIGATION DEVICE Acclarent, Inc. KAM Class I 2006-05-05
K052371 DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS Hair International Systems USA, Inc. GEX Class II 2006-05-04
K052824 KIMBERLY-CLARK PROCEDURE GOWN Kimberly-Clark Corp. FYA Class II 2006-05-02
K060567 SPECTRAGENICS ATS-1 Spectragenics, Inc. GEX Class II 2006-04-28
K060089 TULIP DISPOSABLE CANNULAS Cell Bio-Systems, Inc. QPB Class II 2006-04-27
K060390 SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA Galil Medical , Ltd. GEH Class II 2006-04-27
K053535 VIVAWAVE MICROWAVE ABLATION SYSTEM Valleylab NEY Class II 2006-04-27
K060169 BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F Barrx Medical, Incorporated GEI Class II 2006-04-21
K060555 SPRAYGENIX CRYO ABLATION SYSTEM Crymed Technologies, Inc. GEH Class II 2006-04-21
K060828 MODIFICATION TO ENDOTINE RIBBON Coapt Systems, Inc. GAM Class II 2006-04-19
K053481 KELO-COTE SPRAY Advanced Bio-Technologies, Inc. MDA Class I 2006-04-14
K060680 ATRILAZE SURGICAL ABLATION SYSTEM Medical Cv, Inc. GEX Class II 2006-04-11
K052322 BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 C.R. Bard, Inc. FTM Class II 2006-04-10
K053441 BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE Regent Medical Americas, LLC KGO Class I 2006-04-10
K060823 ARTHROCARE WANDS Arthrocare Corp. GEI Class II 2006-04-10
K053628 LIGHTSHEER DUET LASER SYSTEM Lumenis, Inc. GEX Class II 2006-04-07
K060114 VECTRA LASER SYSTEM Xintec Corporation, Dba, GEX Class II 2006-04-07
K060802 VISUM LED SURGICAL LIGHTING SYSTEM Stryker Communications Corp. FSY Class II 2006-04-07
K060326 LASERTX - DIODE LASER & DELIVERY SYSTEM Prosurg, Inc. GEX Class II 2006-04-05
K060255 E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE E Surgical, LLC GEI Class II 2006-03-31
K050311 ATRIUM MEDICAL CORPORATION C-QUR MESH Atrium Medical Corp. FTL Class II 2006-03-31
K060310 FRAXEL II SR LASER SYSTEM AND ACCESSORIES Reliant Technologies, Inc. GEX Class II 2006-03-29
K052297 POREX ELECTROSURGERY NEEDLE Porex Surgical, Inc. GEI Class II 2006-03-28
K060528 AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE Aesculap, Inc. GAR Class II 2006-03-28
K060520 VITAMESH MACROPOROUS PP SURGICAL MESH Proxy Biomedical , Ltd. FTL Class II 2006-03-28
K060301 PALOMAR LUX1540 HANDPIECE Palomar Medical Technologies, Inc. GEX Class II 2006-03-23
K060239 ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM Alveolus, Inc. ESW Class II 2006-03-22
K060411 RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM Radiancy (Israel) , Ltd. GEX Class II 2006-03-22
K060304 PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 Biotex, Inc. GEX Class II 2006-03-21
K060455 MULTISTAR Asclepion Laser Technologies GmbH GEX Class II 2006-03-20
K053510 IR WIRELESS FOOT SWITCH Linemaster Switch Corp. GEI Class II 2006-03-20
K060459 QUADROSTAR 980 Asclepion Laser Technologies GmbH GEX Class II 2006-03-20
K060457 QUADROSTAR 532 Asclepion Laser Technologies GmbH GEX Class II 2006-03-20
K053047 FRAXEL SR LASER SYSTEM Reliant Technologies, Inc. GEX Class II 2006-03-20
K052777 LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D Ellex Medical Pty, Ltd. GEX Class II 2006-03-16
K053339 ALLOFIX ANCHOR Musculoskeletal Transplant Foundation GAT Class II 2006-03-16
K060216 ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM Energist, Ltd. GEX Class II 2006-03-16
K053495 EQUIPMENT SLUSH DRAPE Advance Medical Designs, Inc. KKX Class II 2006-03-16
K060484 ERBE VIO ESU, MODEL VIO 300 D Erbe USA, Inc. GEI Class II 2006-03-16
K060132 SPINAL USA CEMENT RESTRICTOR SYSTEM Spinal USA JDK Class II 2006-03-16
K052310 CRYOFLOW 700, CRYOFLOW 1000 Uniphy Elektromedizin GmbH & Co. KG GEX Class II 2006-03-15
K053611 SMOOTHSHAPES Bicellulase, Inc. NUV Class II 2006-03-15
K060234 MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM Mccue Plc GEX Class II 2006-03-15
K053290 COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES Valleylab GEI Class II 2006-03-15
K053616 POLARIS WR, ST APPLICATOR Syneron Medical, Ltd. GEX Class II 2006-03-14
K053636 MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) Mani, Inc. GAM Class II 2006-03-14
K053255 NEXUS LIGATING CLIP Microsurgical Laboratories,Inc.Dba Wexler Surgical FZP Class II 2006-03-14
K060419 CONCERTO BIPOLAR NEEDLE ELECTRODE Boston Scientific Corp GEI Class II 2006-03-13
K053511 DA VINCI FEMTOSECOND SURGICAL LASER Sie Ltd Surgical Instrument Engineering GEX Class II 2006-03-10
K053102 BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE Regent Medical Americas, LLC KGO Class I 2006-03-10

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