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
2007-06-26

Clearances · page 63 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K071607 ASA01 HEAVY DUTY SUCTION PUMP Zhongshan A&J Medical Equipment Co., Ltd. BTA Class II 2007-06-26
K070647 TRIFLEX SELECT Cardinal Health, Inc. KGO Class I 2007-06-22
K070924 FLEXGUARD Allmed Systems, Inc. GEX Class II 2007-06-21
K071180 SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 Engineered Medical Solutions Co., LLC FTD Class II 2007-06-20
K062558 MESOSFOL SURGICAL FILM Biomet Manufacturing Corp FTM Class II 2007-06-20
K070288 CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 Medtronic Vascular OCL Class II 2007-06-18
K071218 PROXENON 350, MODEL 902XX Welch Allyn, Inc. FST Class II 2007-06-14
K052936 THERMAGE THERMACOOL SYSTEM Thermage, Inc. GEI Class II 2007-06-12
K070560 LRTM SURGICAL MESH Lifecell Corp. FTM Class II 2007-06-11
K071140 MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 Top Spins, Inc. KCY Class I 2007-06-07
K063740 V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 Kci USA, Inc. OMP Class II 2007-06-07
K063692 V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 Kci USA, Inc. OMP Class II 2007-06-07
K071249 ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV ETHICON, Inc. FTL Class II 2007-06-05
K070692 DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK Dukal Corporation MSH Class II 2007-05-30
K062171 EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES Ortho Development Corp. GEI Class II 2007-05-25
K070887 ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) Ethicon Endo-Surgery, LLC GDW Class II 2007-05-25
K071152 PALOMAR ERBIUM HANDPIECE Palomar Medical Products, Inc. GEX Class II 2007-05-25
K071018 MONARCH NASAL IMPLANT Hanson Medical, Inc. FZE Class II 2007-05-25
K070431 WELMED, INC. SURGICAL GOWNS Welmed, Inc. FYA Class II 2007-05-24
K071301 ANTLIA I WOUND IRRIGATION SYSTEM Innovative Therapies, Inc. OMP Class II 2007-05-24
K063480 STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 Stryker Corp. GEI Class II 2007-05-22
K070934 PANOSOL II TRU-BLU, MODEL UBL-417 National Biological Corp. FTC Class II 2007-05-22
K070536 MEDILAS D FAMILY LASERS Dornier Medtech America, Inc. GEX Class II 2007-05-21
K070284 FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) Reliant Technologies, Inc. GEX Class II 2007-05-17
K071061 ABSORBATACK AND APPLICATOR Sorbx, LLC GDW Class II 2007-05-16
K071295 100W CERALAS D 980NM DIODE LASER Biolitec, Inc. GEX Class II 2007-05-16
K063104 FOX MEDICAL DIODE LASER SYSTEM 810NM Howard Instruments, Inc. GEX Class II 2007-05-16
K070997 DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX Pro-Med Instruments GmbH GEI Class II 2007-05-16
K062525 REPROCESSED LIGASURE VESSEL SEALER/DIVIDER Ascent Healthcare Solutions GEI Class II 2007-05-16
K063680 SHARPOINT PDO (POLYDIOXANONE) SUTURES Surgical Specialties Corp NEW Class II 2007-05-09
K070993 TOPAS SYSTEM American Medical Systems, Inc. FTL Class II 2007-05-09
K071065 ORTHADAPT BIOIMPLANT Pegasus Biologics, Inc. FTM Class II 2007-05-04
K070446 COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL Valleylab,A Division of Tyco Healthcare Group LP GEI Class II 2007-05-02
K070388 PROFILE MULTI-PLATFORM SYSTEM Sciton, Inc GEX Class II 2007-05-02
K070353 KELSEY INTERSITITAL LASER THERAPY SYSTEM Kelsey, Inc. GEX Class II 2007-05-02
K070494 EPI-C PLUS Espansione Marketing S.P.A GEX Class II 2007-05-01
K070893 CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 CSA Medical, Inc. GEH Class II 2007-05-01
K063038 FRAXEL III SR LASER SYSTEM AND ACCESSORIES Reliant Technologies, Inc. GEX Class II 2007-04-27
K063808 FRAXEL IV SR LASER SYSTEM Reliant Technologies, Inc. GEX Class II 2007-04-27
K070018 UNIVERSAL SURGICAL MESH, MODEL 100 Generic Medical Device, Inc. FTL Class II 2007-04-27
K063172 ARTHROCARE CAVITY SPINEWAND Arthrocare Corp. GEI Class II 2007-04-27
K063582 ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE Zimmer, Inc. KGO Class I 2007-04-26
K070374 ARTHROCARE ENT PLASMA WAND Arthrocare Corp. GEI Class II 2007-04-25
K070896 ENSEAL PTC TISSUE SEALING DEVICE Surgrx, Inc. GEI Class II 2007-04-24
K070311 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 Medtronic Vascular GEI Class II 2007-04-24
K070711 INCIRCLE BI-POLAR RF ABLATION SYSTEM Rfa Medical, Inc. GEI Class II 2007-04-24
K070004 ACCENT Alma Lasers , Ltd. GEI Class II 2007-04-23
K070958 MODIFICATION TO ARTHROCARE ARTHROWANDS Arthrocare Corp. GEI Class II 2007-04-23
K070836 EXICLIP EXCS-M Clevex, Inc. MJG Class I 2007-04-20
K070168 N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C Aearo Company MSH Class II 2007-04-18
K070466 REVOLIX DUO LASER SYSTEM Allmed Systems, Inc. GEX Class II 2007-04-17
K070243 SUTRALENE POLYPROPYLENE SUTURES Visionary Medical Supplies, Inc. GAW Class II 2007-04-17
K070224 ULTRAPRO PLUG ETHICON, Inc. FTL Class II 2007-04-17
K070851 ARTHROCARE SPINEWANDS Arthrocare Corp. GEI Class II 2007-04-13
K070894 TEPHAFLEX SURGICAL MESH Tepha, Inc. OOD Class II 2007-04-13
K070904 ANTLIA II SUCTION PUMP SYSTEM Innovative Therapies, Inc. OMP Class II 2007-04-13
K070782 WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F Survivair Respirators, LLC MSH Class II 2007-04-11
K062797 POWDERED LATEX SURGICAL GLOVE Beijing Reagent Latex Products Co., Ltd. KGO Class I 2007-04-11
K070738 SIS FACIAL CYLINDER, SIS FACIAL IMPLANT Cook Biotech, Inc. FTM Class II 2007-04-05
K062963 PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 Ra Medical Systems,Inc GEX Class II 2007-04-03
K070644 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS W. L. Gore & Associates, Inc. FTL Class II 2007-04-02
K070673 FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE Teleflexmedical, Inc. GAT Class II 2007-04-02
K070548 C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. FZP Class II 2007-03-29
K063867 CUTERA ER:YSGG LASER HANDPIECE Cutera, Inc. GEX Class II 2007-03-27
K070138 CUTERA ER:YAG LASER HANDPIECE Cutera, Inc. GEX Class II 2007-03-27
K070476 REVOLIX 120 Allmed Systems, Inc. GEX Class II 2007-03-26
K070407 DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE Dukal Corp. FXX Class II 2007-03-26
K063005 STRYKER T6 HOODS AND TOGAS Stryker Instruments FYA Class II 2007-03-23
K062258 GENESIS DIODE LASER Ivoclar Vivadent, Inc. GEX Class II 2007-03-21
K070073 ALIGN URETHRAL SUPPORT SYSTEM C.R. Bard, Inc. OTN Class II 2007-03-21
K063043 SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP Modern Healthcare Corp. FXX Class II 2007-03-21
K070482 ISIS Galil Medical , Ltd. GEH Class II 2007-03-20
K063556 PERIPATCH ENDO-SLEEVE Pm Devices, Inc. FTM Class II 2007-03-20
K070436 BIOMARC GOLD TISSUE MARKER Carbon Medical Technologies, Inc. NEU Class II 2007-03-16
K070216 VARI-LASE BRIGHT TIP FIBER Vascular Solutions, Inc. GEX Class II 2007-03-16
K070442 POWERLED SURGICAL LIGHT SYSTEM Maquet S.A. FSY Class II 2007-03-16
K063384 DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 Hoya Conbio, Inc. GEX Class II 2007-03-16
K061489 ATRILAZE MI SURGICAL ABLATION SYSTEM Medical Cv, Inc. GEX Class II 2007-03-16
K062479 JOYKEY SURGICAL GOWNS (STERILE) Joykey Industryial , Ltd. FYA Class II 2007-03-14
K070275 FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE Rubicor Medical, Inc. GEI Class II 2007-03-09
K070378 ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2007-03-09
K070192 ATRIUM PROLITE ULTRA S MESH Atrium Medical Corp. FTL Class II 2007-03-08
K063152 CLAROS DENTAL LASER SYSTEM Elexxion AG GEX Class II 2007-03-07
K063648 SURGI-WRAP MAST TENDON SHEET Mast Biosurgery USA, Inc. FTL Class II 2007-03-07
K063001 SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES Lasering S.R.L. GEX Class II 2007-03-07
K070162 FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS Valleylab,A Division of Tyco Healthcare Group LP GEI Class II 2007-03-06
K062480 JOYKEY SURGICAL DRAPES (STERILE) Joykey Industryial , Ltd. KKX Class II 2007-03-05
K070139 WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 Survivair, Inc. MSH Class II 2007-03-02
K063698 CO2 LASER SYSTEM, MODEL C-LAS Clinicon Corp. GEX Class II 2007-03-02
K062762 DERMA YAG El.En Electronic Engineering Spa GEX Class II 2007-03-01
K070065 AMS SINGLE INCISION SLING SYSTEM (SIS-0) American Medical Systems, Inc. PAH Class II 2007-03-01
K061652 PALOMAR LUX1540 HANDPIECE Palomar Medical Products, Inc. GEX Class II 2007-02-27
K063336 MEDELA DOMINANT 50 LIPO, MODEL 600-5706 Medela AG QPB Class II 2007-02-26
K062350 SURGINETICS ADVANTAGEBLADE Surginetics GEI Class II 2007-02-26
K062869 CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G Ethicon Endo-Surgery, LLC GDW Class II 2007-02-26
K063023 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 3M Company MSH Class II 2007-02-23
K063713 AMS SMART SLING SYSTEM American Medical Systems, Inc. OTN Class II 2007-02-22
K063639 AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 Tissuelink Medical, Inc. GEI Class II 2007-02-22
K062464 MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR KARL STORZ Endoscopy-America, Inc. GEI Class II 2007-02-16
K070101 UNIBLATE ELECTROSURGICAL DEVICE Rita Medical Systems, Inc. GEI Class II 2007-02-14

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