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
2010-08-16

Clearances · page 54 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101462 ASCEND BLUE AC MESH; ASCEND BLUE PC MESH Caldera Medical, Inc. FTL Class II 2010-08-16
K100846 IMC SURGICAL FACE MASK International Medsurg Connection FXX Class II 2010-08-16
K100098 PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE Jm System Co., Ltd. GEX Class II 2010-08-13
K100143 PILOT DIODE LASER, MODEL 002-00139 CAO Group, Inc. GEX Class II 2010-08-13
K100786 MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX Bsd Medical Corp. NEY Class II 2010-08-13
K101967 NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' Ellman Int'L, Inc. GEI Class II 2010-08-12
K101658 WATERLASE MD TURBO PLUS MODEL 7200XXX Biolase Technology, Inc. GEX Class II 2010-08-11
K091310 ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 Dfine, Inc. GEI Class II 2010-08-11
K101000 WELLMIEN SURGICAL MASK Wellmien (Suzhou) Import & Export Trading Co., Ltd. FXX Class II 2010-08-09
K102001 MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY Smith & Nephew, Inc. OMP Class II 2010-08-06
K094021 ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I Microsulis Medical Limited NEY Class II 2010-08-06
K102117 TISSU TRANS FILTRON SYRINGE FILL Shippert Medical Technologies Corp. MUU Class II 2010-08-06
K102081 ENDOSCOPIC CLIP SYSTEM Aesculap, Inc. FZP Class II 2010-08-06
K102028 NEOTRACT ANCHOR SYSTEM MODEL TAS400 Neotract, Inc. GAT Class II 2010-08-04
K091018 ARTHREX BIOWIRE Arthrex, Inc. GAS Class II 2010-07-30
K102050 Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 Advanced Technology Laser Co., Ltd. GEX Class II 2010-07-29
K101276 DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 Chemence Medical Products, Inc. MPN Class II 2010-07-28
K100543 MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 Medisiss GEI Class II 2010-07-23
K100558 QUANTA DIODE LASER SYSTEM Quanta System Spa GEX Class II 2010-07-22
K100678 SUPRA SCAN DELIVERY SYSTEM Quantel Medical GEX Class II 2010-07-21
K090661 NES REPROCESSED VARICOSE VEIN RF CATHETER Northeast Scientific, Inc. NUJ Class II 2010-07-21
K100702 STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS Huot Instruments, LLC FSY Class II 2010-07-20
K101108 ERBE ESU MODEL VIO 100 C WITH ACCESSORIES Erbe USA, Inc. GEI Class II 2010-07-16
K092860 LASEMAR 800, 1000, 1500 Eufoton S.R.L. GEX Class II 2010-07-16
K101102 POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE Best Putra Gloves Sdn Bhd KGO Class I 2010-07-16
K101103 POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 Best Putra Gloves Sdn Bhd KGO Class I 2010-07-16
K101851 VENTRALIGHT ST MESH Davol Inc., Sub. C. R. Bard, Inc. FTL Class II 2010-07-15
K101252 NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 Neotract, Inc. GAT Class II 2010-07-15
K093179 MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) H&H Research Company FXX Class II 2010-07-14
K100876 AESCULAP MONOMAX ABSORBABLE SUTURE Aesculap, Inc. NWJ Class II 2010-07-14
K101415 THERACLEAR Theravant Corporation GEX Class II 2010-07-08
K100234 HM-LAMP II Hillusa, Inc. FTD Class II 2010-07-08
K100461 PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT Riverpoint Medical NEW Class II 2010-07-08
K093473 KMD-MARK1 TISSUE MARKER Kent Medical Devices, Inc. NEU Class II 2010-07-02
K100936 GYNECARE TVT ABBREVO CONTINENCE SYSTEM ETHICON, Inc. OTN Class II 2010-07-01
K100816 PK SUPERPULSE SYSEM GENERATOR MODEL 744000 Gyrus Acmi, Inc. GEI Class II 2010-07-01
K101711 CERULEAU ELECTROSURGICAL PROBE Nuortho Surgical, Inc. GEI Class II 2010-07-01
K101190 LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC Led Intellectual Properties, LLC OHS Class II 2010-07-01
K090803 HANSON MEDICAL FACIAL IMPLANTS Hanson Medical, Inc. FZE Class II 2010-06-30
K092992 A4-XLR8 FOAM DRESSING Genadyne Biotechnologies, Inc. OMP Class II 2010-06-29
K101713 LIPCOLLECTOR II Human Med AG MUU Class II 2010-06-29
K101378 FRANKENMAN SURGICAL STAPLERS Suzhou Frankenman Medical Equipment Co., Ltd. GDW Class II 2010-06-29
K093196 BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 Cousin Biotech Sas FTL Class II 2010-06-25
K100884 STRYKER KNIFELIGHT Howmedica Osteonics Corp. FTD Class II 2010-06-25
K092233 SURGIMESH XD Aspide Medical FTL Class II 2010-06-25
K101018 CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 Cardica, Inc. FZP Class II 2010-06-25
K093108 STRYKER BIPOLAR FORCEPS Stryker Leibinger GmbH & Co KG GEI Class II 2010-06-22
K100388 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS Medical Illumination International, Inc. FST Class II 2010-06-22
K101080 NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX Egon Faulhaber Surgical Instruments Pinzetten GEI Class II 2010-06-21
K100333 FIAB SPA, MODELS F7244, F7233, F7234, F7277 Fiab Spa GEI Class II 2010-06-21
K101111 HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 Barrx Medical, Inc. GEI Class II 2010-06-18
K100501 MULTIFUNCTIONAL LINEAR PEN AtriCure, Inc. OCL Class II 2010-06-18
K100638 VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 Depuy Mitek, A Johnson & Johnson Company GEI Class II 2010-06-18
K101440 GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 Generic Medical Devices, Inc. OTN Class II 2010-06-18
K101218 PATCHASSIST Polytouch Medical, Ltd. ORQ Class II 2010-06-17
K100896 GYRUS ACMI HALO PKS CUTTING FORCEPS Gyrus Acmi, Inc. GEI Class II 2010-06-17
K093619 EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E Cook Ireland, Ltd. ESW Class II 2010-06-17
K100893 CHEVEUX DIODE LASER SYSTEM Sandstone Medical Technologies, LLC GEX Class II 2010-06-16
K094009 HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI Halt Medical, Inc. GEI Class II 2010-06-14
K100800 TIDI FACEMASK Tidi Products,Llc FXX Class II 2010-06-14
K101333 CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. GEH Class II 2010-06-14
K101444 AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY Surgical Devices, A Global Business Unit Tyco GDW Class II 2010-06-14
K101274 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM Maquet Cardiovascular, LLC GEI Class II 2010-06-11
K100821 PREVENA INCISION MANAGEMENT SYSTEM Kci USA, Inc. OMP Class II 2010-06-11
K100746 FIBER ONE American Medical Systems GEX Class II 2010-06-11
K093679 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 AtriCure, Inc. FZP Class II 2010-06-10
K100711 SUCTION IRRIGATION ELECTRODES AND ADAPTERS Encision, Inc. GEI Class II 2010-06-09
K100807 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 American Medical Systems, Inc. PAH Class II 2010-06-07
K093537 HANAROSTENT ESOPHAGUS (CCC) M.I.Tech Co., Ltd. ESW Class II 2010-06-04
K101297 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 Coloplast A/S OTM Class II 2010-06-03
K090379 AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES Avita Corporation BTA Class II 2010-05-26
K100686 CONMED MACROLYTE DISPERSIVE ELECTRODE Conmed Corporation GEI Class II 2010-05-21
K093168 MEDIFLASH AND ESTEFLASH Dermeo ONF Class II 2010-05-21
K100194 OPTICAL INTEGRITY LASERGUARD FIBERS Optical Integrity, Inc. GEX Class II 2010-05-20
K101169 DESARA MESH MODEL: CAL-DS01 Caldera Medical, Inc. OTN Class II 2010-05-20
K094061 KENSEY NASH ECM SURGICAL PATCH Kensey Nash Corporation FTM Class II 2010-05-18
K100047 SUREFIT DUAL DISPERSIVE ELECTRODE Conmed Corporation GEI Class II 2010-05-14
K100353 SPINEWAND SURGICAL DEVICE Arthrocare Corp. GEI Class II 2010-05-13
K093123 BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB Biomerix Corporation FTL Class II 2010-05-13
K093087 BWF-5 MEDICAL LASER SERIES Litecure, LLC GEX Class II 2010-05-12
K100006 HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED Riverpoint Medical GAT Class II 2010-05-10
K093161 ACTIPROTECT UF N95 RESPIRATOR Glaxosmithkline Consumer Healthcare ONT Class II 2010-05-10
K100257 VLOC9ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, A Division of Tyco Healthcare GAM Class II 2010-05-10
K093747 ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS C.R. Bard, Inc. OTN Class II 2010-05-07
K093909 BUSSE SURGICAL DRAPES IV Busse Hospital Disposables, Inc. KKX Class II 2010-05-06
K101197 PARIE TENE PROGRIP MESH Sofradim Production FTL Class II 2010-05-05
K100423 DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 ETHICON, Inc. MPN Class II 2010-05-04
K100139 SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 Safelife Corp. MSH Class II 2010-05-04
DEN090005 PRINEO SKIN CLOSURE SYSTEM Closure Medical Corp. OMD Class II 2010-04-30
K100994 PRELOADED TISSUE MARKER DEVICE Carbon Medical Technologies, Inc. NEU Class II 2010-04-30
K100723 DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 Changzhou Kangdi Medical Stapler Co., Ltd. GDW Class II 2010-04-30
K100258 ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 Wickimed Supply Limited GEI Class II 2010-04-28
K100378 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 Daavlin Distributing Co. FTC Class II 2010-04-28
K093241 V7 PORTABLE SUCTION UNITS Hersill, S.L. BTA Class II 2010-04-27
K091987 ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP LeMaitre Vascular, Inc. FZP Class II 2010-04-23
K093799 TORNIER SURGICAL MESH Tornier, Inc. FTL Class II 2010-04-22
K100229 VENTRIO HERNIA PATCH C.R. Bard, Inc. FTL Class II 2010-04-21
K100415 ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM Lumenis GEX Class II 2010-04-21
K100208 IMC SURGICAL DRAPE International Medsurg Connection KKX Class II 2010-04-20
K093511 SORING MBC200/BCC140 Soring GmbH Medizintechnik GEI Class II 2010-04-16

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