| JNE IMPLANT SYSTEM (K072425) | GC America, Inc. | 2008-03-10 |
| MRJ EXTENDED (K080098) | Paramed S.R.L. | 2008-03-10 |
| DUREX PLAY MASSAGE GEL LUBRICANT (K063385) | Ssl Americas, Inc. | 2008-03-10 |
| MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K080258) | Endius, Inc. | 2008-03-10 |
| MERRIES K-PHATE BONE GRAFT SUBSTITUTE (K063157) | Merries International, Inc. | 2008-03-10 |
| 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 (K080422) | Eizo Nanao Corporation | 2008-03-10 |
| ZIMMER POROLOCK MIS STEM (K071723) | Zimmer GmbH | 2008-03-07 |
| TENS/IF 14 (K071869) | Emsi | 2008-03-07 |
| VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 (K073028) | Venowave, Inc. | 2008-03-07 |
| DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX (K073488) | Diazyme Laboratories | 2008-03-07 |
| CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS (K080286) | Straumann USA | 2008-03-07 |
| ALMA LASER NIR MODULE (K080318) | Alma Lasers , Ltd. | 2008-03-07 |
| GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K073286) | Zimmer, Inc. | 2008-03-07 |
| JET PORT PLUS HP CATHETER SYSTEM (K072481) | Pfm Medical, Inc. | 2008-03-07 |
| CONVOY ADVANCED DELIVERY SHEATH (K072719) | Boston Scientific Corp | 2008-03-07 |
| US/SS/GS SYSTEM (K073247) | Osstem Implant Co., Ltd. | 2008-03-07 |
| COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET (K073374) | William Cook Europe Aps | 2008-03-07 |
| AMADEUS ADAPTIVE COMPRESSION THERAPY (K071763) | Convatec | 2008-03-07 |
| HU II / HS II FIXTURE SYSTEM (K080387) | Osstem Implant Co., Ltd. | 2008-03-07 |
| JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE (K072212) | Smith & Nephew, Inc. | 2008-03-07 |
| CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144) | Smiths Medical MD, Inc. | 2008-03-07 |
| DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K080415) | Terumo Medical Corp. | 2008-03-07 |
| CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT (K073345) | Biomet 3i, Inc. | 2008-03-07 |
| REPLUS DENTAL IMPLANTS (HA) (K073161) | Implant Direct, LLC | 2008-03-07 |
| COMPACT AUTO-SAFETY INJECTOR (CASI) (K073476) | Medical House (Asi) Limited | 2008-03-07 |
| LUMINEX LX 100/200 INSTRUMENT (K073506) | Luminex Corp. | 2008-03-07 |
| LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM (K070800) | Ansell Healthcare Products, LLC | 2008-03-06 |
| AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX (K073470) | Stryker Spine | 2008-03-06 |
| MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM (K080155) | Intuitive Surgical, Inc. | 2008-03-06 |
| DBEST ONE STEP OCCULT BLOOD TEST KITS (K071242) | Ameritek USA, Inc. | 2008-03-06 |
| HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 (K072163) | 3A Health Care S.R.L. | 2008-03-06 |
| SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 (K080171) | Sanarus Medical, Inc. | 2008-03-06 |
| K-Y BRAND YOURS+MINE (K072421) | Mcneil-Ppc, Inc. | 2008-03-06 |
| PORTABLE VENTILATOR, MODEL EPV-100 (K072214) | Allied Healthcare Products, Inc. | 2008-03-06 |
| ROCHE-CREACTIVE PROTEIN (LATEX) (K073277) | Roche Diagnostics Corp. | 2008-03-06 |
| APX21 (K073185) | Techdent Technologies, Ltd. | 2008-03-06 |
| PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM (K073118) | Diagnostic Devices, Inc. | 2008-03-05 |
| ABX PENTRA URINE CAL (K071779) | Horiba Abx | 2008-03-05 |
| IONTOPHORESIS SYSTEM (K073276) | Acclarent, Inc. | 2008-03-05 |
| PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES (K073544) | Rj Medical, Inc. | 2008-03-05 |
| MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF (K071244) | Medline Industries, Inc. | 2008-03-05 |
| BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE (K073299) | Betel Care Sdn. Bhd. | 2008-03-05 |
| CAMLOG IMPLANT SYSTEM ABUTMENTS (K073553) | Altatec GmbH | 2008-03-05 |
| COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG (K080340) | Novartis Nutrition Corp. | 2008-03-05 |
| LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (K073552) | Laborie Medical Technologies, Corp. | 2008-03-05 |
| IVS TUNNELLER DEVICES (K073164) | Covidien UK Manufacturing, Ltd. | 2008-03-05 |
| HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 (K080322) | Hycor Biomedical, Inc. | 2008-03-05 |
| XTRAC ULTRA 2, MODEL AL10000 (K073659) | Photo Medex, Inc. | 2008-03-05 |
| RADIO BIOAQUACARE (K080471) | Bioartificial Gel Technologies (Bagtech), Inc. | 2008-03-05 |
| SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR (K080193) | Synergeyes, Inc. | 2008-03-05 |
| QUANTA LITE CCP3.1 IGG/IGA ELISA (K072944) | Inova Diagnostics, Inc. | 2008-03-05 |
| VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM (K073279) | Visionsense, Ltd. | 2008-03-05 |
| VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) (K080066) | Gx Corporation Sdn Bhd | 2008-03-05 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS (K073589) | Becton, Dickinson & CO | 2008-03-05 |
| ALICIA MENSTRUAL CUP (K070965) | Alicia International Pty , Ltd. | 2008-03-05 |
| CAPIOX CIRCUIT CONNECTORS (K073474) | Terumo Corp. | 2008-03-05 |
| ANCHORAGE ACCESS KIT (K073507) | Epitek, Inc. | 2008-03-05 |
| FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY (K070355) | Fotona D.D. | 2008-03-04 |
| QPLAQUE MR (K073156) | Medis Medical Imaging Systems BV | 2008-03-04 |
| TWINFIX PK FP SUTURE ANCHOR (K073509) | Smith & Nephew, Inc. | 2008-03-04 |
| LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 (K072793) | Moeller Medical GmbH & Co. KG | 2008-03-04 |
| BAXANO ULTRA LOW PROFILE RONGEUR (K080494) | Baxano, Inc. | 2008-03-04 |
| FLEXOR EVAC ASPIRATION CATHETER (K073627) | Cook, Inc. | 2008-03-04 |
| CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM (K073119) | Taidoc Technology Corporation | 2008-03-03 |
| VISTAKON (NARAFILCON) A SOFT CONTACT LENS (K073485) | Johnson & Johnson Vision Care, Inc. | 2008-03-03 |
| NIOX MINO (K072816) | Aerocrine AB | 2008-03-03 |
| PLEXUR M (K073405) | Osteotech, Inc. | 2008-03-03 |
| LED CURING LIGHT (K080035) | Monitex Industrial Co., Ltd. | 2008-03-03 |
| OMNILUX NEW-U (K072459) | Photo Therapeutics, Inc. | 2008-03-03 |
| BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR (K073339) | Fenwal, Inc. | 2008-03-03 |
| MINITAPE EXTRA URETHRAL SLING (K073647) | Mpathy Medical Devices, Ltd. | 2008-03-03 |
| AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (K072683) | Xoft, Inc. | 2008-02-29 |
| SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI (K073380) | Sorin Group Italia S.R.L. | 2008-02-29 |
| ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT (K073540) | Atlantis Components, Inc. | 2008-02-29 |
| ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM (K080176) | Aloka Co., Ltd. | 2008-02-29 |
| 5.5 MM SUTURE LOCK BONE SCREW ANCHOR (K080229) | Kfx Medical | 2008-02-29 |
| SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE (K072802) | Ultrawin Sdn Bhd | 2008-02-29 |
| THE PROXIVENT KIT (K073061) | Coll Partners , Ltd. | 2008-02-29 |
| ACCIN PATELLOFEMORAL SYSTEM (K073120) | Accelerated Innovation, LLC | 2008-02-29 |
| SYNGO IMAGING CCF VA10A (K073418) | Siemens AG Medical Solutions | 2008-02-29 |
| DC ULNAR SHORTENING SYSTEM (K073228) | Orthopro, LLC | 2008-02-29 |
| SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM (K073402) | Synthes (Usa) | 2008-02-29 |
| MAJOR III BLOOD GLUCOSE MONITORING SYSTEM (K072274) | Bestgen Biotech Corp. | 2008-02-29 |
| EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW (K073688) | Exactech, Inc. | 2008-02-29 |
| VIDAS NT-PROBNP ASSAY, MODEL: 30 449 (K073091) | bioMerieux, Inc. | 2008-02-29 |
| HEART SYNC, MODELS C-100 AND T-100 (K080421) | Heart Sync, LLC | 2008-02-29 |
| INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS (K072211) | Intuitive Surgical, Inc. | 2008-02-28 |
| SMART COUPLER, MODEL M015401 (K073384) | Intelligent Hearing Systems | 2008-02-28 |
| EEG NEUROAMP, MODEL CS10137 (K073557) | Corscience GmbH & Co. KG | 2008-02-28 |
| SPECTRA MRSA (K073027) | Thermo Fisher Scientific | 2008-02-28 |
| ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL (K073191) | Thermofisher Scientific OY | 2008-02-28 |
| LIMITED ARTIFACT SKULL PIN, MODEL 0107 (K073163) | Dinkler Surgical Devices, Inc. | 2008-02-28 |
| PRIMAEVA MEDICAL SYSTEM (K080145) | Primaeva Medical, Inc. | 2008-02-28 |
| PACIFICA (K073407) | Or-Nim Medical , Ltd. | 2008-02-28 |
| AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE (K080006) | Cynosure, Inc. | 2008-02-28 |
| SYGNAL DBM (K073329) | Musculoskeletal Transplant Foundation | 2008-02-28 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 (K072054) | Bionime Corporation | 2008-02-28 |
| CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES (K073459) | Ciba Vision Corporation | 2008-02-28 |
| MODIFICATION TO:NESS L300 (K080219) | Ness-Neuromuscular Electrical Stimulation Systems | 2008-02-28 |
| VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM (K080107) | bioMerieux, Inc. | 2008-02-28 |