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
2005-03-18

Clearances · page 70 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K043329 OMNILUX REVIVE AND BLUE Photo Therapeutics Limited GEX Class II 2005-03-18
K032666 MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES Medline Industries, Inc. KKX Class II 2005-03-16
K050184 BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE Regent Medical Americas, LLC KGO Class I 2005-03-16
K041541 COMPEL MLR SURGICAL GOWNS Standard Textile Co., Inc. FYA Class II 2005-03-16
K043004 STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 Viasys Medsystems FYA Class II 2005-03-16
K050361 MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE Boston Scientific Corp GEI Class II 2005-03-14
K050108 SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS Innovaquartz GEX Class II 2005-03-14
K050412 VAPORMAX Trimedyne, Inc. GEX Class II 2005-03-14
K050344 LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER Ethicon Endo Surgery, Inc. FZP Class II 2005-03-14
K042893 UNDER BUTTOCKS DRAPE International Medsurg Connection, Inc. KKX Class II 2005-03-11
K042319 RELIANT LASER II SYSTEM AND ACCESSORIES Reliant Technologies, Inc. GEX Class II 2005-03-10
K050452 AURORA SR AND SRA APPLICATOR Syneron Medical, Ltd. GEX Class II 2005-03-09
K050364 MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM Valley Forge Scientific Corp. GEI Class II 2005-03-09
K050148 MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT Mentor Corporation OTN Class II 2005-03-09
K050337 SIS FISTULA PLUG Cook Biotech, Inc. FTM Class II 2005-03-09
K043585 MEDLINE SURGICAL GOWNS Medline Industries, Inc. FYA Class II 2005-03-08
K043017 PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS Medline Industries, Inc. FYA Class II 2005-03-08
K043591 FEATHERLIFT EXTENDED APTOS THREAD Kmi Kolster Methods, Inc. GAW Class II 2005-03-04
K050247 CONTOUR NECKLIFT THREADS Surgical Specialties Corp GAW Class II 2005-03-04
K043486 PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 Topcon Medical Laser Systems, Inc. GEX Class II 2005-03-03
K041999 GYRUS PLASMA SKIN RESURFACING SYSTEM Gyrus Medical, Inc. GEI Class II 2005-03-02
K043133 AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR Ceremed , Inc. KKY Class II 2005-03-02
K050347 MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. GEH Class II 2005-02-25
K043575 DERMILLUME, MODEL PRO1000 Care Electronics, Inc. GEX Class II 2005-02-24
K050223 VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER Vivant Medical, Inc. GEI Class II 2005-02-24
K043255 ELLIPSE LIGHT SPT Danish Dermatologic Development A/S GEX Class II 2005-02-24
K050317 BURANE XL Wavelight Laser Technologie AG GEX Class II 2005-02-24
K043602 QUADRANT RETRACTOR SYSTEM Medtronic Sofamor Danek GAD Class I 2005-02-23
K042274 PSD-60/ENDOPLASMA Olympus Shirakawa Co., Ltd. GEI Class II 2005-02-22
K050187 PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES Sofradim Production FTL Class II 2005-02-18
K043199 SURGICAL FACE MASK Hong YA Non-Woven Products Co., Ltd. FXX Class II 2005-02-16
K050218 WAVELIGHT SINON Wavelight Laser Technologie AG GEX Class II 2005-02-15
K041690 MONARCH NASAL IMPLANT Hanson Medical, Inc. FZE Class II 2005-02-11
K040780 ELECTROSURGICAL PENCILS Hangzhou Shuyou Medical Instrument Company, Ltd. GEI Class II 2005-02-10
K043251 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B Candela Corp. GEX Class II 2005-02-09
K050090 GEL MARK V Senorx, Inc. NEU Class II 2005-02-07
K050161 SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY Conmed Electrosurgery GEI Class II 2005-02-03
K041224 FOOTHILLS SURGICAL DRAPES Foothills Industries, Inc. KKX Class II 2005-02-03
K043046 COOLTOUCH, MODEL CT3S New Star Lasers, Inc. GEX Class II 2005-02-01
K050102 E-Z PEN, REUSEABLE HANDSWITCHING PENCIL Megadyne Medical Products, Inc. GEI Class II 2005-02-01
K050069 CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT Cutera, Inc. GEX Class II 2005-01-31
K043173 Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES Lumenis, Ltd. GEX Class II 2005-01-31
K041642 V.A.C. GRANUFOAM SILVER DRESSING Kinetic Concepts, Inc. OMP Class II 2005-01-25
K043508 DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) Ansell Healthcare Products, LLC KGO Class I 2005-01-19
K040103 SOUNDSKIN PHOTOTHERAPY SYSTEM Bhc International, Ltd. GEX Class II 2005-01-18
K043402 THERMAGE THERMACOOL SYSTEM Thermage, Inc. GEI Class II 2005-01-14
K041879 PALOMAR LUX1064 HANDPIECE Palomar Medical Technologies, Inc. GEX Class II 2005-01-13
K041086 PALOMAR STARLUX PULSED LIGHT SYSTEM Palomar Medical Products, Inc. GEX Class II 2005-01-13
K042567 POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E Pt. Medisafe Technologies KGO Class I 2005-01-13
K043429 CYNERGY LASER Cynosure, Inc. GEX Class II 2005-01-12
K043544 MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR Medela AG BTA Class II 2005-01-07
K043310 SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM Synthes (Usa) HWE Class I 2005-01-05
K043273 LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS Valleylab GEI Class II 2005-01-05
K042288 UNICRYL United Medical Industries Co. , Ltd. GAM Class II 2004-12-27
K042038 MTF ALLOGRAFT ANCHOR Musculoskeletal Transplant Foundation GAT Class II 2004-12-23
K043056 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. FTL Class II 2004-12-22
K043081 GORE POLYPROPYLENE HERNIA MESH W. L. Gore & Associates, Inc. FTL Class II 2004-12-22
K041810 SERFAS ENERGY SYSTEM Stryker Endoscopy GEI Class II 2004-12-21
K042132 NOVASYS TRANSURETHRAL RF SYSTEM Novasys Medical, Inc. NVJ Class II 2004-12-21
K042000 MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS Msq (M2) , Ltd. GEX Class II 2004-12-21
K043291 CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 Medtronic Vascular GEI Class II 2004-12-21
K042654 PROTECTION PLUS EARLOOP PROCEDURE MASK Safety-Med Products, Inc. FXX Class II 2004-12-17
K043319 CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES Novalis Medical, LLC GEX Class II 2004-12-17
K042943 NOUVAG AG - VACUSON 40 AND VACUSON 60 NOUVAG AG BTA Class II 2004-12-17
K043366 PERMACOL SURGICAL IMPLANT Tissue Science Laboratories, Plc FTL Class II 2004-12-17
K042349 EMG MODEL SUA01 SUCTION UNIT Emg Technology Co., Ltd. JCX Class II 2004-12-16
K040270 OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM Lumenis, Ltd. GEX Class II 2004-12-16
K031425 GENTLEWAVES LED PHOTOMODULATION DEVICE Light Bioscience, LLC GEX Class II 2004-12-15
K041011 ULTRALIGHT II ND:YAG LASER SYSTEM Sandstone Medical Technologies, LLC GEX Class II 2004-12-14
K042592 INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 American Medical Systems, Inc. OTN Class II 2004-12-14
K042785 MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 Nidek, Inc. GEX Class II 2004-12-14
K042285 UNICRYL M United Medical Industries Co. , Ltd. NEW Class II 2004-12-10
K043164 PANALIGHT-BLU, MODEL 4175 Dusa Pharmaceuticals, Inc. GEX Class II 2004-12-10
K042131 PROMEDICAL SURGICAL DRAPES Promedical Products Co., Ltd. KKX Class II 2004-12-10
K043298 BLUE ORTHOCORD SUTURE Depuy Mitek NEW Class II 2004-12-10
K042111 PROMEDICAL SURGICAL GOWNS Promedical Products Co., Ltd. FYA Class II 2004-12-10
K041553 ARTHREX SUTURE GRAFTING KIT Arthrex, Inc. GAT Class II 2004-12-10
K042574 ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) Cardinalhealth KGO Class I 2004-12-08
K042284 UNIMIDE United Medical Industries Co. , Ltd. GAR Class II 2004-12-03
K042856 CONTOUR FOREHEAD/BROWLIFT THREAD Surgical Specialties Corp GAW Class II 2004-12-03
K042395 OUTPATIENT III MINOR SURGERY LIGHT Burton Medical Products Corp. FSY Class II 2004-12-01
K041047 ULTRADENT CARBON MASK - UPI #342 Medspring Group, Incorporated FXX Class II 2004-12-01
K041957 EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS Diomed, Inc. GEX Class II 2004-12-01
K042286 UNIESTER C United Medical Industries Co. , Ltd. GAT Class II 2004-12-01
K042283 UNIPRO United Medical Industries Co. , Ltd. GAW Class II 2004-12-01
K043115 LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) Niti Medical Technologies , Ltd. FZP Class II 2004-12-01
K042282 UNISILK United Medical Industries Co. , Ltd. GAP Class II 2004-12-01
K041080 SURGICAL DRAPE KIT - D.I.R.R.A. SRL D.I.R.R.A. S.R.L. LRO Class II 2004-11-30
K040744 ATRILAZE SOFT TISSUE ABLATION SYSTEM Medical Cv, Inc. GEX Class II 2004-11-30
K042382 DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD Med-General Technologies, LLC FSY Class II 2004-11-30
K041501 GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS Guangzhou Fortunique , Ltd. MMP Class II 2004-11-30
K042968 MCL 30 DERMABLATE ER:YAG LASER SYSTEM Asclepion Laser Technologies GmbH GEX Class II 2004-11-24
K042918 MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 Endooptiks, Inc. GEX Class II 2004-11-22
K041242 CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. GEX Class II 2004-11-22
K042897 AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE Ethicon Endo-Surgery, Inc. GAL Class II 2004-11-19
K041323 PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA New Star Lasers, Inc. GEX Class II 2004-11-17
K043012 OMNIPULSE MINI, MODEL 2120 Trimedyne, Inc. GEX Class II 2004-11-17
K043008 SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM Surgrx, Inc. GEI Class II 2004-11-17
K033095 SMOKE EVACUATION ATTACHEMENT Modern Medical Equipment Mfg., Ltd. GEI Class II 2004-11-17
K041632 MINIMESH POLYPROPYLENE MESH Mpathy Medical Devices, Ltd. OTO Class II 2004-11-17

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