meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
32
Latest Decision
2009-02-06

Clearances · page 58 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K081398 ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES Advanced Medical Innovations, Inc. GEI Class II 2009-02-06
K082825 ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM Energist, Ltd. GEX Class II 2009-02-06
K083781 EEA HEMORRHOID STAPLER & ACCESSORIES Surgical Devices, A Global Business Unit Covidien GDW Class II 2009-02-04
K083034 FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F Fotona D.D. GEX Class II 2009-02-04
K083898 SURGIMEND Tei Biosciences, Inc. FTM Class II 2009-02-04
K082407 MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM Sandstone Medical Technologies, LLC GEX Class II 2009-02-03
K083918 ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 Advanced Technology Laser Co., Ltd. GEX Class II 2009-02-02
K083711 MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 Barrx Medical, Incorporated GEI Class II 2009-02-02
K083748 IPULSE, MODEL: I150 Cyden Limited GEX Class II 2009-02-02
K083258 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE Dornier Medtech America, Inc. GEX Class II 2009-01-30
K080782 NITI-S ESOPHAGEAL STENT Taewoong Medical Co., Ltd. ESW Class II 2009-01-30
K083574 RELIEVA STRATUS MICROFLOW SPACER Acclarent, Inc. KAM Class I 2009-01-29
K083915 ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC Advanced Technology Laser Co., Ltd. GEX Class II 2009-01-29
K083528 SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 Smith & Nephew, Inc. GEI Class II 2009-01-28
K083323 NUVO VERDE LED LIGHTING SYSTEM Nuvo, Inc. FSY Class II 2009-01-28
K083718 BEAU RX SCAR CARE GEL Beau RX Solutions, LLC MDA Class I 2009-01-26
K083856 INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 Relievant Medsystems, Inc. GEI Class II 2009-01-22
K083795 CYNOSURE SMARTLIPO MPX LASER Cynosure, Inc. GEX Class II 2009-01-21
K082409 SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 Endophotonix, Inc. GEX Class II 2009-01-21
K081307 OMNILUX CLEAR-U Photo Therapeutics, Inc. OLP Class II 2009-01-16
K082518 DUAL NEEDLE SUTURE PASSER SYSTEM Cayenne Medical, Inc. GAT Class II 2009-01-16
K082955 ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 Ethicon Endo-Surgery, Inc. GEI Class II 2009-01-15
K083537 MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM Medwaves Incorporated NEY Class II 2009-01-15
K081377 NUVASIVE SURGICAL MESH SYSTEM Nuvasive, Inc. FTL Class II 2009-01-15
K082748 ATRIUM PROLITE S MESH Atrium Medical Corp. FTL Class II 2009-01-14
K083082 MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS Moor Instruments, Ltd. GEX Class II 2009-01-13
K083162 STINGRAY ELECTROSURGICAL FORCEPS Stingray Surgical Products, Inc. GEI Class II 2009-01-12
K082622 ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE Alma Lasers , Ltd. NUV Class II 2009-01-12
K083682 180W CERELAS D 980NM DIODE LASER, MODEL D180 Biolitec, Inc. GEX Class II 2009-01-09
K083730 ISOLAZ Aesthera Corporation GEX Class II 2009-01-09
K083721 MODIFICATION TO ZENIEVA River'S Edge Pharmaceuticals, LLC NAE Class I 2009-01-08
K082941 BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 Biomerix Corporation FTL Class II 2009-01-07
K082750 ENTACT SEPTAL STAPLER, MODEL 610-00100 Entrigue Surgical, Inc. OLL Class II 2009-01-06
K082396 DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 C.R. Bard, Inc. GDW Class II 2009-01-02
K083452 ERBE MODEL VIO 300 D WITH ACCESSORIES Erbe USA, Inc. GEI Class II 2008-12-31
K082203 NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 Ncontact Surgical, Inc. OCL Class II 2008-12-30
K081060 FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 Core Essence Orthopaedics, LLC GAQ Class II 2008-12-24
K083613 QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY Quanta System Spa GEX Class II 2008-12-23
K082938 EZLASE Biolase Technology, Inc. GEX Class II 2008-12-22
K083476 NOVEON MODEL LS1100-03 Nomir Medical Technologies, Inc. GEX Class II 2008-12-22
K082643 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE Depuy Mitek, A Johnson & Johnson Company GEI Class II 2008-12-19
K082993 SURGISEAL TOPICAL SKIN ADHESIVE Adhezion Biomedical MPN Class II 2008-12-19
K082911 SMOOTHCOOL HR SYSTEM Jeisys Medical, Inc. GEX Class II 2008-12-19
K083527 INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS Power Medical Interventions, Inc. GDW Class II 2008-12-18
K082956 ALPHA ORTHOPAEDICS AT2 SYSTEM Alpha Orthopaedics GEI Class II 2008-12-18
K082809 ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM Lumenis, Inc. GEX Class II 2008-12-18
K082676 GENADYNE A4 WOUND VACUUM SYSTEM Genadyne Biotechnologies, Inc. OMP Class II 2008-12-18
K082079 REGEN COLLAGEN SCAFFOLD (CS) Regen Biologics, Inc. OLC Class II 2008-12-18
K082731 ML24000 UVA-1 PHOTOTHERAPY CABINET Daavlin Distributing Co. FTC Class II 2008-12-17
K082725 GRAFTGUARD PRESSURE CONTROLLING SYRINGE Maquet Cardiovascular, LLC GBX Class I 2008-12-17
K083272 SKINCLEAR Q-SWITCHED ND:YAG LASER Global USA Distribution, LLC GEX Class II 2008-12-16
K080741 MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc. GEI Class II 2008-12-16
K082278 MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS Ethicon Endo-Sugery, LLC NEU Class II 2008-12-16
K083379 CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE Cynosure, Inc. GEX Class II 2008-12-12
K081095 PROLITE III TOWER AND PR AND HR HANDPIECE Quantel S.A. GEX Class II 2008-12-12
K082902 RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES Rz Medizintechnik GmbH GEI Class II 2008-12-10
K083306 MODIFICATION TO ARTHROCARE ARTHROWANDS Arthrocare Corp. GEI Class II 2008-12-10
K082297 BUSSE SURGICAL DRAPE Busse Hospital Disposables, Inc. KKX Class II 2008-12-09
K083013 PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 Gyrus Acmi, Inc. GEI Class II 2008-12-09
K082962 TIVAMED COOLED RF SYSTEM, MODEL 78001 Tivamed, Inc. GEI Class II 2008-12-04
K081848 LIPOSE FAT TRANSFER SYSTEM Lipose Corp. MUU Class II 2008-12-04
K082423 NO!NO! SKIN Radiancy (Israel) , Ltd. GEX Class II 2008-12-03
K082225 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 Biolitec, Inc. GEX Class II 2008-12-03
K082786 PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES Peak Surgical, Inc. GEI Class II 2008-12-03
K082535 COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE Surgical Devices, A Global Business Unit Covidien GAT Class II 2008-12-01
K082208 DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER Scivolutions, Inc. NAC Class I 2008-12-01
K083039 VERITAS COLLAGEN MATRIX (DRY) Synovis Surgical Innovations FTM Class II 2008-11-26
K082415 PRODIGY NPWT SYSTEM MODEL PRODIGY 800V Premco Medical Systems, Inc. OMP Class II 2008-11-25
K072687 VALLEYLAB MICROWAVE ABLATION GENERATOR Covidien Lp, Formerly Know AS Valleylab, A Divison NEY Class II 2008-11-25
K081713 VERTEBRAL ACCESS SYSTEM BY VIDACARE Vidacare Corporation MOQ Class I 2008-11-21
K082284 AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM Alveolus, Inc. JCT Class II 2008-11-20
K080796 SRI LP DRAPE Sri/Surgical Express KKX Class II 2008-11-17
K082568 SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE Bovie Medical GEI Class II 2008-11-17
K082176 LTM-BPS SURGICAL MESH Lifecell Corp. FTM Class II 2008-11-14
K080591 TANDA SKINCARE SYSTEM, MODEL: PTSCS Pharos Life Corporation GEX Class II 2008-11-14
K082211 RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS Smith & Nephew, Inc. OMP Class II 2008-11-14
K083207 ULTRAWAVE III EX 1320 Quanta System Spa GEX Class II 2008-11-14
K083069 EZLASE 10W Biolase Technology, Inc. GEX Class II 2008-11-13
K080442 SERISCAFFOLD SURGICAL MESH Serica Technologies, Inc. FTL Class II 2008-11-13
K080723 SRI LP GOWN Sri/Surgical Express, Inc. FYA Class II 2008-11-13
K080707 SRI PLR GOWN Sri/Surgical Express FYA Class II 2008-11-13
K082762 AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE Aardvark Medical JCX Class II 2008-11-12
K082876 BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY Sharplight Technologies, Ltd. GEX Class II 2008-11-10
K082101 LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE Sandstone Medical Technologies, LLC GEX Class II 2008-11-05
K082980 ARTHROCARE ARTHROWANDS Arthrocare Corp. GEI Class II 2008-11-05
K081312 ARAGON ONESHOT SYSTEM Aragon Surgical, Inc. GEI Class II 2008-10-31
K083066 CHROMOPHARE E 778 AND E 558 Berchtold Holding GmbH FSY Class II 2008-10-30
K082178 TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. NWJ Class II 2008-10-30
K082721 LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS Photo Medex, Inc. GEX Class II 2008-10-28
K082263 CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 Biolitec, Inc. GEX Class II 2008-10-24
K081352 PROFILE MULTI-PLATFORM SYSTEM Sciton, Inc GEX Class II 2008-10-23
K082298 FLASH N' GO Home Skinovations , Ltd. GEX Class II 2008-10-23
K082865 MODIFICATION TO ZENIEVA Gorbec Pharmaceutical Services, Inc. NAE Class I 2008-10-23
K081791 E-Z CLEAN ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. GEI Class II 2008-10-21
K080629 PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS Promedical Products Co., Ltd. KKX Class II 2008-10-20
K082954 ENCAGE BIPOLAR RF PROBE Trod Medical SA GEI Class II 2008-10-17
K082687 COLLAMEND FM IMPLANT C.R. Bard, Inc. FTM Class II 2008-10-17
K081408 ELLIPSE MULTIFLEX Ellipse A/S GEX Class II 2008-10-17
K082640 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM Coloplast Manufacturing Us, LLC OTM Class II 2008-10-17
K082928 STRAIGHT FIRE HOLMIUM LASER FIBER Boston Scientific Corp GEX Class II 2008-10-16

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