| SYNCHRO HP PLATFORM (K082039) | El.En Electronic Engineering Spa | 2009-03-20 |
| STERIS CMAX XLT SURGICAL TABLE (K090136) | STERIS Corporation | 2009-03-20 |
| TAC-TITE (TM) (K090128) | Core Essence Orthopaedics, Inc. | 2009-03-19 |
| AFFIRM CO2 AND AFFIRM CO2 HP (K081424) | Cynosure, Inc. | 2009-03-19 |
| ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U (K090547) | C.R. Bard, Inc. | 2009-03-18 |
| SECURIAN TISSUE REINFORCEMENT MATRIX (K083823) | Xylos Corporation | 2009-03-18 |
| ELITE MPX LASER SYSTEM WITH XPL HANDPIECE (K090235) | Cynosure, Inc. | 2009-03-17 |
| SMOOTHLIPO (K083478) | Eleme Medical, Inc. | 2009-03-17 |
| PICASSO LASER SYSTEM (K083142) | Amd Lasers, LLC | 2009-03-13 |
| AERO DV TRACHEOBRONCHIAL STENT SYSTEM (K083625) | Alveolus, Inc. | 2009-03-11 |
| DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE (K083320) | Dukal Corp. | 2009-03-06 |
| ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE (K090084) | Merit Medical Systems, Inc. | 2009-03-06 |
| BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 (K090501) | Biopsy Sciences, LLC | 2009-03-05 |
| ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES (K090281) | Accutech Medical Technologies, Inc. | 2009-03-04 |
| OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 (K083357) | Kci USA, Inc. | 2009-03-04 |
| GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 (K083471) | Generic Medical Device, Inc. | 2009-03-03 |
| ATRICURE CRYO1 CRYO-ABLATION PROBE (K082074) | AtriCure, Inc. | 2009-03-02 |
| SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (K082682) | Cook Biotech, Inc. | 2009-02-27 |
| ATMOS C361/C451 SUCTION PUMP (K090445) | Atmos, Inc. | 2009-02-27 |
| ERBIUM FRACTIONAL HANDPIECE (K083900) | Palomar Medical Products, Inc. | 2009-02-27 |
| BUSSE SURGICAL DRAPE (K083424) | Busse Hosipital Disposables | 2009-02-26 |
| LH-75T PHOTOTHERAPY SYSTEM (K090097) | Lerner Medical Devices, Inc. | 2009-02-26 |
| RENASYS GO NEGATIVE PRESSURE WOUND THERAPY (K083375) | Smith & Nephew, Inc. | 2009-02-25 |
| QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING (DEN070002) | Quick-Med Technologies, Inc. | 2009-02-25 |
| EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- (K083281) | Linvatec Corp. | 2009-02-25 |
| CHROMOPHARE E 668 (K090378) | Berchtold GmbH & Co. KG | 2009-02-23 |
| DERMABLATE EFFECT (K081541) | Asclepion Laser Technologies GmbH | 2009-02-23 |
| RETRACTOR LITE (K083710) | Thomas Surgical Instruments, Inc. | 2009-02-23 |
| SMOOTHSHAPES (K083629) | Eleme Medical, Inc. | 2009-02-19 |
| AXXION LIGHT GUIDE (K082992) | Spinal Elements, Inc. | 2009-02-18 |
| NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125 (K090202) | Ncontact Surgical, Inc. | 2009-02-17 |
| PALOMAR ASPIRE LASER PLATFORM (K083165) | Palomar Medical Products, Inc. | 2009-02-13 |
| LIQUIBAND ULTIMA, MODEL LB0004 (K083531) | Medlogic Global , Ltd. | 2009-02-12 |
| MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200 (K082565) | Microsurgeon, Inc. | 2009-02-12 |
| MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE (K083500) | Dornier Medtech America, Inc. | 2009-02-12 |
| WATERLASE MD (K090181) | Biolase Technology, Inc. | 2009-02-11 |
| HALO ABLATION CATHETER (K083737) | Barrx Medical, Incorporated | 2009-02-10 |
| BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER (K083006) | Biopsy Sciences, LLC | 2009-02-09 |
| ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES (K081398) | Advanced Medical Innovations, Inc. | 2009-02-06 |
| ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM (K082825) | Energist, Ltd. | 2009-02-06 |
| INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES (K090159) | Incisive Surgical, Inc. | 2009-02-06 |
| SURGIMEND (K083898) | Tei Biosciences, Inc. | 2009-02-04 |
| FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F (K083034) | Fotona D.D. | 2009-02-04 |
| EEA HEMORRHOID STAPLER & ACCESSORIES (K083781) | Surgical Devices, A Global Business Unit Covidien | 2009-02-04 |
| MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM (K082407) | Sandstone Medical Technologies, LLC | 2009-02-03 |
| MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 (K083711) | Barrx Medical, Incorporated | 2009-02-02 |
| IPULSE, MODEL: I150 (K083748) | Cyden Limited | 2009-02-02 |
| ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 (K083918) | Advanced Technology Laser Co., Ltd. | 2009-02-02 |
| NITI-S ESOPHAGEAL STENT (K080782) | Taewoong Medical Co., Ltd. | 2009-01-30 |
| MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE (K083258) | Dornier Medtech America, Inc. | 2009-01-30 |
| RELIEVA STRATUS MICROFLOW SPACER (K083574) | Acclarent, Inc. | 2009-01-29 |
| ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC (K083915) | Advanced Technology Laser Co., Ltd. | 2009-01-29 |
| NUVO VERDE LED LIGHTING SYSTEM (K083323) | Nuvo, Inc. | 2009-01-28 |
| SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 (K083528) | Smith & Nephew, Inc. | 2009-01-28 |
| BEAU RX SCAR CARE GEL (K083718) | Beau RX Solutions, LLC | 2009-01-26 |
| INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 (K083856) | Relievant Medsystems, Inc. | 2009-01-22 |
| CYNOSURE SMARTLIPO MPX LASER (K083795) | Cynosure, Inc. | 2009-01-21 |
| SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 (K082409) | Endophotonix, Inc. | 2009-01-21 |
| DUAL NEEDLE SUTURE PASSER SYSTEM (K082518) | Cayenne Medical, Inc. | 2009-01-16 |
| OMNILUX CLEAR-U (K081307) | Photo Therapeutics, Inc. | 2009-01-16 |
| MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM (K083537) | Medwaves Incorporated | 2009-01-15 |
| ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 (K082955) | Ethicon Endo-Surgery, Inc. | 2009-01-15 |
| NUVASIVE SURGICAL MESH SYSTEM (K081377) | Nuvasive, Inc. | 2009-01-15 |
| ATRIUM PROLITE S MESH (K082748) | Atrium Medical Corp. | 2009-01-14 |
| MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS (K083082) | Moor Instruments, Ltd. | 2009-01-13 |
| STINGRAY ELECTROSURGICAL FORCEPS (K083162) | Stingray Surgical Products, Inc. | 2009-01-12 |
| ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE (K082622) | Alma Lasers , Ltd. | 2009-01-12 |
| ISOLAZ (K083730) | Aesthera Corporation | 2009-01-09 |
| 180W CERELAS D 980NM DIODE LASER, MODEL D180 (K083682) | Biolitec, Inc. | 2009-01-09 |
| MODIFICATION TO ZENIEVA (K083721) | River'S Edge Pharmaceuticals, LLC | 2009-01-08 |
| BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 (K082941) | Biomerix Corporation | 2009-01-07 |
| ENTACT SEPTAL STAPLER, MODEL 610-00100 (K082750) | Entrigue Surgical, Inc. | 2009-01-06 |
| DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 (K082396) | C.R. Bard, Inc. | 2009-01-02 |
| ERBE MODEL VIO 300 D WITH ACCESSORIES (K083452) | Erbe USA, Inc. | 2008-12-31 |
| NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 (K082203) | Ncontact Surgical, Inc. | 2008-12-30 |
| FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (K081060) | Core Essence Orthopaedics, LLC | 2008-12-24 |
| QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY (K083613) | Quanta System Spa | 2008-12-23 |
| NOVEON MODEL LS1100-03 (K083476) | Nomir Medical Technologies, Inc. | 2008-12-22 |
| EZLASE (K082938) | Biolase Technology, Inc. | 2008-12-22 |
| SMOOTHCOOL HR SYSTEM (K082911) | Jeisys Medical, Inc. | 2008-12-19 |
| 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE (K082643) | Depuy Mitek, A Johnson & Johnson Company | 2008-12-19 |
| SURGISEAL TOPICAL SKIN ADHESIVE (K082993) | Adhezion Biomedical | 2008-12-19 |
| REGEN COLLAGEN SCAFFOLD (CS) (K082079) | Regen Biologics, Inc. | 2008-12-18 |
| GENADYNE A4 WOUND VACUUM SYSTEM (K082676) | Genadyne Biotechnologies, Inc. | 2008-12-18 |
| INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS (K083527) | Power Medical Interventions, Inc. | 2008-12-18 |
| ALPHA ORTHOPAEDICS AT2 SYSTEM (K082956) | Alpha Orthopaedics | 2008-12-18 |
| ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM (K082809) | Lumenis, Inc. | 2008-12-18 |
| GRAFTGUARD PRESSURE CONTROLLING SYRINGE (K082725) | Maquet Cardiovascular, LLC | 2008-12-17 |
| ML24000 UVA-1 PHOTOTHERAPY CABINET (K082731) | Daavlin Distributing Co. | 2008-12-17 |
| SKINCLEAR Q-SWITCHED ND:YAG LASER (K083272) | Global USA Distribution, LLC | 2008-12-16 |
| MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (K080741) | Megadyne Medical Products, Inc. | 2008-12-16 |
| MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS (K082278) | Ethicon Endo-Sugery, LLC | 2008-12-16 |
| CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE (K083379) | Cynosure, Inc. | 2008-12-12 |
| PROLITE III TOWER AND PR AND HR HANDPIECE (K081095) | Quantel S.A. | 2008-12-12 |
| MODIFICATION TO ARTHROCARE ARTHROWANDS (K083306) | Arthrocare Corp. | 2008-12-10 |
| RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES (K082902) | Rz Medizintechnik GmbH | 2008-12-10 |
| PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 (K083013) | Gyrus Acmi, Inc. | 2008-12-09 |
| BUSSE SURGICAL DRAPE (K082297) | Busse Hospital Disposables, Inc. | 2008-12-09 |
| TIVAMED COOLED RF SYSTEM, MODEL 78001 (K082962) | Tivamed, Inc. | 2008-12-04 |
| LIPOSE FAT TRANSFER SYSTEM (K081848) | Lipose Corp. | 2008-12-04 |