meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
38
Latest Decision
2005-10-31

Clearances · page 68 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K052979 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE Isolux, LLC HBI Class II 2005-10-31
K050689 SURGICAL FACE MASK China Surgical Dressings Center Co., Ltd. FXX Class II 2005-10-26
K050460 GYRUS PLASMACISION AND PLASMABLEND ELECTRODES Gyrus Medical, Inc. GEI Class II 2005-10-25
K052859 AQUAMANTYS PUMP GENERATOR SYSTEM Tissuelink Medical, Inc. GEI Class II 2005-10-25
K052893 ATRICURE TRANSPOLAR SYSTEM AtriCure, Inc. GEI Class II 2005-10-25
K051214 ALUMA SKIN RENEWAL SYSTEM Lumenis, Inc. GEI Class II 2005-10-24
K052857 ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 Senorx, Inc. GEI Class II 2005-10-21
K052104 ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION Conmed Corporation GEI Class II 2005-10-21
K052652 SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE Smith & Nephew, Inc. GAT Class II 2005-10-21
K052286 DEUTSCH ANTI-BLOCKAGE WOUND DRAIN The Catheter Exchange, Inc. GBX Class I 2005-10-21
K051562 NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR Terang Nusa Sdn Bhd KGO Class I 2005-10-20
K052203 AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 Kirwan Surgical Products, Inc. GEI Class II 2005-10-20
K052778 THERMAGE THERMACOOL SKIN MARKETING Thermage, Inc. GEI Class II 2005-10-20
K052155 BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED C.R. Bard, Inc. FTL Class II 2005-10-20
K052449 CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 Codman & Shurtleff, Inc. GEI Class II 2005-10-17
K052175 I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 Uroplasty, Inc. OTN Class II 2005-10-17
K052482 ARTELON SURGICAL SUTURE Artimplant AB GAR Class II 2005-10-17
K041704 NEWGEL AND NEWGEL PLUS E Newmedical Technology, Inc. MDA Class I 2005-10-17
K052806 BURANE Wavelight Laser Technologie AG GEX Class II 2005-10-17
K052660 MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO The Richmond Light Co. FTC Class II 2005-10-17
K052495 ATRILAZE MALLEABLE ABLATION PROBE Medical Cv, Inc. GEX Class II 2005-10-11
K052336 SPECTRAQUATTRO PULSED LIGHT SYSTEM Amjet Distribution, LLC GEX Class II 2005-10-11
K052003 VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) Vnus Medical Technologies, Inc. GEI Class II 2005-10-11
K052183 SORING GMBH SONOCA LIPO Soring GmbH Medizintechnik QPB Class II 2005-10-07
K051607 NOVASPINE CEMENT RESTRICTOR NSCR Novaspine, LLC JDK Class II 2005-10-07
K052506 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 Rubicor Medical, Inc. GEI Class II 2005-10-06
K052141 STRYKER STILETTO ELECTROSURGICAL PROBE Stryker Endoscopy GEI Class II 2005-10-06
K051879 SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS Synthes (Usa) FTM Class II 2005-10-05
K052367 SCIENT'X CEMENT RESTRICTOR Scient'X JDK Class II 2005-10-05
K052626 SMARTSUCTION HARMONY DEVICE Haemonetics Corp. BTA Class II 2005-10-05
K052686 ARTHROCARE ARTHROWANDS Arthrocare Corp. GEI Class II 2005-10-05
K051508 MED FLASH II INTENSE PULSED LIGHT SYSTEM. General Project S.R.L. GEX Class II 2005-10-05
K043494 MASTEL LASER CLEAN ROOM, MODEL EBS-100 Mastel Precision Surgical Instruments, Inc. FYD Class II 2005-10-04
K052415 POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS Power Medical Interventions, Inc. GDW Class II 2005-09-29
K051701 VICRYL * MESH BAG ETHICON, Inc. FTL Class II 2005-09-29
K052009 CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR Conmed Corporation GEI Class II 2005-09-28
K052373 QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE Quill Medical, Inc. GAW Class II 2005-09-26
K051048 SURGISIS STAPLE LINE REINFORCEMENT II Cook Biotech, Inc. FTM Class II 2005-09-23
K052274 GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 Guidant Corporation GEI Class II 2005-09-21
K051291 NON-STERILE SURGICAL MASK A.R. Medicom, Inc. FXX Class II 2005-09-20
K051259 VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 Theralight, Inc. GEX Class II 2005-09-20
K052324 POLARIS LV, LVA APPLICATOR Syneron Medical, Ltd. GEX Class II 2005-09-14
K050382 AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM Cynosure, Inc. GEX Class II 2005-09-14
K052030 SURGEON'S GLOVE, POWDER FREE Shun Thai Rubber Gloves Industry Public Co., Ltd. KGO Class I 2005-09-13
K051749 COBRA SURGICAL SYSTEM Estech, Inc. GEI Class II 2005-09-13
K052031 POWDERED LATEX SURGEON'S GLOVE Shun Thai Rubber Gloves Industry Public Co., Ltd. KGO Class I 2005-09-12
K051876 MULTIWAVE XR Pacific Quantum Instruments, Inc. GEX Class II 2005-09-09
K051956 DR. OPPEL ST-501 Sometech Incorporated GEI Class II 2005-09-08
K051281 THE NEEDLE CATCHER E.D.Medical , Ltd. HTD Class I 2005-09-08
K042287 UNIPLAIN & UNICHROM United Medical Industries Co. , Ltd. GAL Class II 2005-09-07
K051831 GEMINI SURGICAL CONTROL & DISPLAY SYSTEM Applied Surgical, LLC GEI Class II 2005-09-07
K050411 ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM Zimmer, Inc. KCY Class I 2005-09-02
K051671 RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY Radiancy (Israel) , Ltd. GEX Class II 2005-09-02
K052035 CANADY PLASMA PROBES Canady Technology, LLC GEI Class II 2005-08-31
K051421 INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR Medical Device Technologies, Inc. NEU Class II 2005-08-30
K051301 PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES Ethicon Endo-Surgery, Inc. GDW Class II 2005-08-30
K052129 LUMENIS 1000 INTEGRATED SLIT LAMP Lumenis, Inc. GEX Class II 2005-08-30
K052246 MODIFICATION TO EN-BLOC BIOPSY SYSTEM Neothermia Corporation GEI Class II 2005-08-22
K050969 INCLOSE SURGICAL MESH SYSTEM Anulex Technologies, Inc. FTL Class II 2005-08-18
K051996 DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 Diomed, Ltd. GEX Class II 2005-08-18
K051793 ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) Ansell Healthcare Products, LLC KGO Class I 2005-08-17
K051758 PENUMBRA ASPIRATION PUMP, MODEL 115V Penumbra, Inc. BTA Class II 2005-08-17
K051786 MELIDE FIBEROPTIC LIGHT Designs For Vision, Inc. FST Class II 2005-08-15
K050575 FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM Futumeds Sdn Bhd MDM Class I 2005-08-15
K051420 HABIB 4X Emcision , Ltd. GEI Class II 2005-08-15
K043015 3L SURGICAL DRAPES 3l Medical Products Co., Ltd. KKX Class II 2005-08-15
K043259 BIOBLANKET SURGICAL MESH Kensey Nash Corp. FTM Class II 2005-08-15
K051700 OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR Medchannel, LLC GAM Class II 2005-08-15
K050899 BIOGEL LATEX STERILE POWDER-FREE GLOVE Regent Medical Americas, LLC KGO Class I 2005-08-12
K051848 SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 Davol Inc., Sub. C. R. Bard, Inc. GDW Class II 2005-08-11
K051505 SCB/STERIS OR-LIGHT INTERFACE BOX KARL STORZ Endoscopy-America, Inc. FTA Class II 2005-08-11
K051766 ORTHOMEND Tei Biosciences, Inc. FTL Class II 2005-08-11
K051533 I-STOP Cl Medical OTN Class II 2005-08-11
K052100 MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH Proxy Biomedical , Ltd. FTL Class II 2005-08-11
K051644 VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR Valleylab GEI Class II 2005-08-11
K050824 100W CERALAS D 980 LASER SYSTEM, MODEL D100 Biolitec, Inc. GEX Class II 2005-08-10
K051428 VTRAC EXCIMER LAMP SYSTEM Photo Medex, Inc. GEX Class II 2005-08-09
K051434 COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV New Star Lasers, Inc. GEX Class II 2005-08-09
K050216 OMNILUX REVIVE AND OMNILUX PLUS Photo Therapeutics Limited GEX Class II 2005-08-09
K043388 PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH Pegasus Biologics, Inc. FTM Class II 2005-08-05
K051609 QUILL SYNTHETIC ABSORBABLE BARBED SUTURE Quill Medical, Inc. NEW Class II 2005-08-04
K051485 AMS PELVIC FLOOR REPAIR SYSTEM American Medical Systems, Inc. OTO Class II 2005-08-03
K030146 KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ Kavo America NVK Class II 2005-08-03
K051426 CARLO SURGICAL GOWN Sofilm Technology Co., Ltd. FYA Class II 2005-08-02
K051429 CLARIS NON-STICK BIPOLAR FORCEPS Guenter Bissinger Medizintechnik GmbH GEI Class II 2005-07-29
K041893 INTRALASE FS LASER Intra Lase Corp. GEX Class II 2005-07-29
K051287 VARI-LASE ENDOVENOUS LASER PROCEDURE KIT Vascular Solutions, Inc. GEX Class II 2005-07-29
K051488 MEDICINELODGE ZIPKNOT Medicinelodge, Inc. NVH Class II 2005-07-27
K051509 ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES Erbe USA, Inc. GEH Class II 2005-07-27
K051627 VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT Valleylab GEI Class II 2005-07-22
K051710 THERMAGE THERMACOOL COUPLING FLUID Thermage, Inc. GEI Class II 2005-07-19
K043032 DEALIGHT IPL Europro, Inc. GEX Class II 2005-07-19
K051625 BARRIER SURGICAL DRAPES Molnlycke Health Care, Inc. KKX Class II 2005-07-14
K051359 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY Candela Corp. GEX Class II 2005-07-13
K033579 REPROCESSED MULTIPLE CLIP APPLIERS Clearmedical, Inc. NMJ Class II 2005-07-11
K051621 ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM Alveolus, Inc. ESW Class II 2005-07-11
K033578 REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS Clearmedical, Inc. NLL Class II 2005-07-11
K051530 MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. American Medical Systems, Inc. OTN Class II 2005-07-08
K050832 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT Bard Peripheral Vascular, Inc. JCT Class II 2005-07-07
K051268 RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT Radiancy, Ltd. GEX Class II 2005-07-06

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