meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
40
Latest Decision
2014-02-19

Clearances · page 45 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K140170 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE Cardica, Inc. GDW Class II 2014-02-19
K132953 TIDISHEILD Tidi Products,Llc PEM Class II 2014-02-18
K132464 PTFE SURGICAL SUTURE Omnia Spa NBY Class II 2014-02-12
K133273 LIGER MEDICAL ESU-110 Liger Medical, LLC GEI Class II 2014-02-12
K140116 RESTORELLE Y CONTOUR MESH Coloplast A/S OTO Class II 2014-02-12
K133201 SHASER V-MINI 2 HAIR REMOVAL SYSTEM Shaser, Inc. ONF Class II 2014-02-12
K132472 JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD Justright Surgical, LLC GDW Class II 2014-02-11
K132613 SONILASE LIGHT THERAPY DEVICE Biorenew Labs, LLC OHS Class II 2014-02-05
K131696 VESALIUS Telea Electronic Engineering Srl GEI Class II 2014-01-31
K131571 AVD RIGHT RADIAL DRAPE Advanced Vascular Dynamics KKX Class II 2014-01-31
K132643 UV PHOTOTHERAPY Xuzhou Kernel Medical Equipment Co., Ltd. FTC Class II 2014-01-30
K140019 ARTHREX BIOSUTURE Arthrex, Inc. GAT Class II 2014-01-30
K132300 EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE Applied Medical Resources Corp. GEI Class II 2014-01-24
K140058 ATRICURE CRYO MODULE SYSTEM AtriCure, Inc. GEH Class II 2014-01-24
K132815 PUREGRAFT 50 SYSTEM Cytori Therapeutics, Inc. MUU Class II 2014-01-24
K133726 MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc. GEI Class II 2014-01-24
K132989 SPEED 808 DIODE LASER SYSTEM Beijing Toplaser Technology Co., Ltd. GEX Class II 2014-01-23
K132286 HYPERION LONG PULSED ND: YAG LASER Scarlet Rf, Inc. GEX Class II 2014-01-22
K133938 ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY Covidien GDW Class II 2014-01-22
K131837 CO2 FRACTIONAL LASER Beijing Honkon Technologies Co., Ltd. GEX Class II 2014-01-22
K131857 Q-SWITCHED ND:YAG LASER Beijing Honkon Technologies Co., Ltd. GEX Class II 2014-01-16
K133473 ILUMINAGE SKIN SMOOTHING LASER Cynosure, Inc. OHS Class II 2014-01-15
K130735 SYNTHETIC ABSORBABLE SUTURE Foosin Medical Supplies Inc., Ltd. GAM Class II 2014-01-14
K130737 SYNTHETIC ABSORBABLE SUTURE Foosin Medical Supplies Inc., Ltd. GAM Class II 2014-01-14
K133499 SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA Suzhou Beinuo Medical Equipment Co. , Ltd. GDW Class II 2014-01-14
K132669 PROXIFAST ABSORBABLE STAPLE Surgimatix, Inc. GDW Class II 2014-01-13
K133762 ENDO GIA(TM) EXTRA LONG ADAPTER Covidien, LLC GDW Class II 2014-01-08
K130681 ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER Biolitec Sia GEX Class II 2014-01-08
K132581 MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE Cardica, Inc. GDW Class II 2014-01-07
K133167 MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD Intuitive Surgical, Inc. GEI Class II 2014-01-07
K133413 IDSS SLC Black Diamond Video FTA Class II 2014-01-07
K131461 LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI Led Intellectual Properties, LLC OLP Class II 2014-01-06
K132661 LIGHTSCALPEL Lightscalpel, LLC GEX Class II 2014-01-02
K132747 VISUM BLADE LED SURGICAL LIGHTING SYSTEM Stryker Communications FSY Class II 2013-12-30
K132308 CLIQ DV-300 ASPIRATOR Ding Hwa Co., Ltd. JCX Class II 2013-12-30
K133283 CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS Candela Corp. GEX Class II 2013-12-26
K130519 PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS Philips Lighting Company FTC Class II 2013-12-24
K132386 TOTALSHIELD SURGICAL HELMET SYSTEM Zimmer, Inc. FYA Class II 2013-12-23
K132708 BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. NEU Class II 2013-12-20
K132671 STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM Stryker Corporation JCX Class II 2013-12-20
K133169 MESO TENDON MATRIX Kensey Nash Corporation Dba Dsm Biomedical OWY Class II 2013-12-20
K133338 LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) Covidien, Formerly Valleylab, A Division of Tyco H GEI Class II 2013-12-20
K132243 BARLE TISSUE ADHESIVE 2 Advanced Medical Solutions (Plymouth), Ltd. MPN Class II 2013-12-20
K123006 AIR BARRIER SYSTEM (ABS) Nimbic Systems, Inc. ORC Class II 2013-12-20
K131879 KC 300 SURGICAL MASK Kimberly-Clark Corp. FXX Class II 2013-12-20
K124064 YOUNG AGAIN Espansione Marketing S.P.A OHS Class II 2013-12-19
K132837 LINA POWERBLADE PLUS Lina Medical Aps GEI Class II 2013-12-19
K133561 VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH AngioDynamics, Inc. GEX Class II 2013-12-19
K131758 SURGEN U Pollogen, Ltd. GEI Class II 2013-12-18
K130738 ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS Nanjing Maidixin Medical Device Co., Ltd. GDW Class II 2013-12-13
K132441 BARD VENTRALEX HERNIA PATCH C.R. Bard, Inc. FTL Class II 2013-12-13
K132754 NEOGEN PSR SYSTEM Energist, Ltd. GEI Class II 2013-12-12
K131596 WOUND MEASURING & MONITORING DEVICE Woundvision, LLC FXN Class I 2013-12-11
K132028 ULTHERA SYSTEM Ulthera, Inc. OHV Class II 2013-12-11
K133180 ERBE ESU MODEL VIO DV WITH ACCESSORIES Erbe USA, Inc. GEI Class II 2013-12-11
K131649 ME Syneron Beauty , Ltd. ONF Class II 2013-12-11
K132185 FAMILY OF COOLGLIDE AESTHETIC LASERS Cutera, Inc. GEX Class II 2013-12-06
K130004 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation ESW Class II 2013-12-06
K133356 PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, Inc. GAW Class II 2013-12-06
K130669 SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS Olsen Medical GEI Class II 2013-12-06
K131229 SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS American Medical Systems OTN Class II 2013-12-05
K132079 TFCC FAST-FIX KIT Smith & Nephew, Inc. GAT Class II 2013-12-05
K133425 SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT Engineered Medical Solutions Co., LLC FTD Class II 2013-12-05
K131095 DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS El.En Electronic Engineering Spa GEX Class II 2013-12-05
K133202 HEM-O-LOK LIGATING CLIP Teleflex Medical FZP Class II 2013-12-03
K132463 CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM Cianna Medical, Inc. NEU Class II 2013-12-03
K132743 HARVESTING CANNULA Maquet Cardiovascular, LLC GEI Class II 2013-12-03
K132974 AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR Medtronic Advanced Energy, LLC GEI Class II 2013-12-03
K130329 SURGISEAL TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC MPN Class II 2013-12-03
K132134 OPTIFIX ABSORBABLE FIXATION SYSTEM C.R. Bard, Inc. GDW Class II 2013-12-02
K133420 TRANQUILL BARBED DEVICE Surgical Specialties Corp. Dba Angiotech NEW Class II 2013-11-29
K131142 GENESIS LED WANDS Genesis Biosystems, Inc. GEX Class II 2013-11-27
K132658 HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS Teleflex Medical FZP Class II 2013-11-27
K132170 SHASER V-MINI RX Shaser, Inc. ONF Class II 2013-11-26
K132699 AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) Tyrx, Inc. FTL Class II 2013-11-26
K130199 CLARITY LPC LASER SYSTEM Lutronic Corporation GEX Class II 2013-11-22
K132655 RETROARC RETROPUBIC SLING SYSTEM American Medical Systems, Inc. OTN Class II 2013-11-20
K133276 V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS Kci USA, Inc. OMP Class II 2013-11-19
K132741 V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM Kci USA, Inc. OMP Class II 2013-11-15
K131672 MICROCYN SCAR MANAGEMENT HYDROGEL Oculus Innovative Sciences PFP Class I 2013-11-15
K130997 NEOVEIL Gunze Limited OXC Class II 2013-11-15
K130689 SYMPHONY RF GENERATOR Thermigen, Inc. GEI Class II 2013-11-15
K122490 KULAVAC CG Bio Co., Ltd. OMP Class II 2013-11-13
K131839 DC 7 Dc International, LLC GEX Class II 2013-11-07
K132307 VIDA LED SURGICAL LIGHTING SYSTEM Convida Healthcare & Systems Corporation FSY Class II 2013-11-05
K131894 NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT Nidek Co., Ltd. GEX Class II 2013-10-31
K132357 SMITH & NEPHEW ULTRATAPE Smith & Nephew, Inc. GAT Class II 2013-10-30
K131893 AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS Ajw Technology Consultants, Inc. FSY Class II 2013-10-30
K132025 MESO BILAYER SURGICAL MESH Kensey Nash Corporation Dba Dsm Biomedical FTM Class II 2013-10-30
K130459 TRIA FAN SYSTEM Tria Beauty, Inc. ONG Class II 2013-10-25
K130428 COVAMESH Biomup S.A. FTL Class II 2013-10-25
K131058 BIPOLAR FORCEPS Boston Endo-Surgical Technologies, Inc. GEI Class II 2013-10-25
K131162 MIRADRY SYSTEM Miramar Labs, Inc. OUB Class II 2013-10-25
K131473 (QUANTA SYSTEM) SURGICAL LASER FIBERS Quanta System Spa GEX Class II 2013-10-24
K131530 DYNAMESH -CICAT Feg Textiltechnik Forschungs-Und Entwicklungsgesel FTL Class II 2013-10-23
K132493 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY Covidien, LLC GDW Class II 2013-10-23
K132446 RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE Smith & Nephew, Inc. OMP Class II 2013-10-23
K132727 GEM FLOW COUPLER DEVICE AND SYSTEM Synovis Life Technologies, Inc. MVR Class II 2013-10-22
K131663 ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK Ethicon Endo-Surgery, LLC GDW Class II 2013-10-18
K131859 MULTIFUNCTIONAL SERIES Beijing Honkon Technologies Co., Ltd. ONF Class II 2013-10-18

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