| BS-200 CHEMISTRY ANALYZER, MODE BS-200 (K072018) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-02-01 |
| GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 (K073200) | Vascular Solutions, Inc. | 2008-02-01 |
| BONALIVE GRANULES (K071199) | Vivoxid , Ltd. | 2008-02-01 |
| DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE (K063350) | PAJUNK GmbH Medizintechnologie | 2008-02-01 |
| NEOTRACT ANCHOR SYSTEM (K073651) | Neotract, Inc. | 2008-02-01 |
| HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE (K072123) | Biowave Corporation | 2008-02-01 |
| PRISMAFLEX SYSTEM, VERSION 3.20 (K072093) | Gambro | 2008-02-01 |
| HRI 6500, 6600 AND 6700 SERIES V2MASKS (K071149) | Hans Rudolph, Inc. | 2008-02-01 |
| SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE (K080106) | Leonhard Lang GmbH | 2008-02-01 |
| MSTAR MPD4500 (K073457) | Xinaomdt Technology Co., Ltd. | 2008-02-01 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER (K072889) | The Binding Site, Ltd. | 2008-02-01 |
| NTRAINER SYSTEM (K071866) | Kcbiomedix, Inc. | 2008-02-01 |
| DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) (K072270) | Diazyme Laboratories | 2008-02-01 |
| AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC (K070985) | Osypka Medical, Inc. | 2008-02-01 |
| SPECTRA HAIR REMOVAL LASER (K053527) | Spectragenics, Inc. | 2008-02-01 |
| VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER (K072798) | Abbott Vascular-Vascular Solutions | 2008-01-31 |
| HANDHELD BASE UNIT (K072920) | Roche Diagnostics Corp. | 2008-01-31 |
| SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 (K071646) | Idev Technologies, Inc. | 2008-01-31 |
| 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II (K073559) | Edwards Lifesciences Research Medical | 2008-01-31 |
| CERVICAL MD, MODEL C10 (K072691) | Sti Medical Systems | 2008-01-31 |
| FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 (K072002) | Draeger Medical AG & Co. KG | 2008-01-31 |
| CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER (K080121) | Cynosure, Inc. | 2008-01-31 |
| RESUSCITATION TIMER, MODEL L770-CPR (K073171) | Allied Healthcare Products, Inc. | 2008-01-31 |
| PROVISA CEM (K073539) | Cavex Holland BV | 2008-01-31 |
| MODIFICATION TO PROXIS SYSTEM (K073563) | St Jude Medical | 2008-01-31 |
| NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX (K072363) | Biomet 3i, Inc. | 2008-01-31 |
| ACCIN ANTERIOR CERVICAL PLATE SYSTEM (K073530) | Accelerated Innovation, LLC | 2008-01-31 |
| VENTRI 1.1 (K080124) | Ge Medical Systems F.I. Haifa | 2008-01-31 |
| GE DATEX-OHMEDA AISYS (K073707) | Datex-Ohmeda, Inc. | 2008-01-30 |
| HERO VASCULAR ACCESS DEVICE (K071778) | Graftcath, Inc. | 2008-01-30 |
| PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER (K072538) | United Medical Systems, Inc. | 2008-01-30 |
| SOFTPAP CERVICAL CELL COLLECTOR (K072381) | Cytocore, Inc. | 2008-01-30 |
| DEPUY ASR 300 ACETABULAR CUP SYSTEM (K073413) | DePuy Orthopaedics, Inc. | 2008-01-30 |
| MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (K072257) | More Diagnostics | 2008-01-30 |
| GELSPRAY WOUND DRESSING (K073663) | Biocure, Inc. | 2008-01-30 |
| WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM (K073573) | Agamatrix | 2008-01-30 |
| SOMNOMED BFLEX (K073004) | Somnomed, Inc. | 2008-01-30 |
| ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K073267) | Endius, Inc. | 2008-01-30 |
| ARDIS SPACER (K073202) | Abbott Spine, Inc. | 2008-01-30 |
| AMS MINIARC SLING SYSTEM (K073703) | American Medical Systems, Inc. | 2008-01-30 |
| ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO (K070514) | Aln Implants Chirurgicaux | 2008-01-30 |
| LYOPHILIZED MULTIBLAST MEDIUM KIT (K072608) | Irvine Scientific Sales Co., Inc. | 2008-01-30 |
| SMALL LUMEN PERITONEAL CATHETER (K073139) | Medtronic Neurosurgery | 2008-01-30 |
| VEINOPLUS NEUROMUSCULAR STIMULATOR (K072252) | Ad Rem Technology Sarl | 2008-01-30 |
| MAXCEM 2 (K073209) | Kerr Corporation | 2008-01-29 |
| VALEO PEDICLE SCREW SPINAL SYSTEM (K073430) | Amedica Corp. | 2008-01-29 |
| DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP (K073676) | DePuy Orthopaedics, Inc. | 2008-01-29 |
| ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE (K073719) | Advanced Surgical Concepts | 2008-01-29 |
| NUVASIVE HELIX MINI ACP SYSTEM (K073275) | Nuvasive, Inc. | 2008-01-29 |
| DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, (K073092) | Spire Biomedical, Inc. | 2008-01-29 |
| SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS (K073135) | Synthes (Usa) | 2008-01-29 |
| ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE (K062534) | Drg Intl., Inc. | 2008-01-29 |
| HARDYDISK AST DORIPENEM 10 UG (K080019) | Hardy Diagnostics | 2008-01-29 |
| SOLCART B (K072760) | B. Braun Medizintechnologie GmbH | 2008-01-29 |
| AXIS SYSTEM (K072989) | Dentsply Intl., Inc. | 2008-01-28 |
| QUANTA LITE F-ACTIN IGA ELISA (K072967) | Inova Diagnostics, Inc. | 2008-01-28 |
| BUTREX BUTTRESS PLATING SYSTEM (K072943) | X-Spine Systems, Inc. | 2008-01-28 |
| DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 (K073701) | Dane Technologies | 2008-01-28 |
| ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS (K073233) | Advanced Bio-Surfaces, Inc. | 2008-01-28 |
| QUANTUM-MIS CANNULATED SYSTEM (K080026) | Pioneer Surgical Technology | 2008-01-28 |
| IMPULSE 6000D/7000DP (K072114) | Fluke Biomedical | 2008-01-28 |
| PEGASUS STEERABLE (PTCA) GUIDEWIRE (K073655) | Lake Region Mfg., Inc. | 2008-01-28 |
| MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM (K080075) | Elite Surgical Supplies (Pty), Ltd. | 2008-01-28 |
| KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 (K073670) | Orex Computed Radiography, Ltd. | 2008-01-25 |
| BENGAL STACKABLE CAGE SYSTEM (K073649) | Depuy Spine, Inc. | 2008-01-25 |
| KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR (K073257) | Kawasumi Laboratories, Inc. | 2008-01-25 |
| WATERLASE MD DERM (K071734) | Biolase Technology, Inc. | 2008-01-25 |
| AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE (K072754) | Axenic Dental, Inc. | 2008-01-25 |
| ORTHO ANCHOR SCREWS (K073461) | Mis Implants Technologies , Ltd. | 2008-01-25 |
| MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM (K073625) | Ge Healthcare Systems Information Technologies | 2008-01-25 |
| OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM (K073656) | Hypermed, Inc. | 2008-01-25 |
| ALGO 5 NEWBORN HEARING SCREENER (K073665) | Natus Medical, Inc. | 2008-01-25 |
| REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES (K072753) | Rg Medical USA | 2008-01-25 |
| VERIFY CHALLENGE PACKS - VERSION 2 (K073683) | STERIS Corporation | 2008-01-25 |
| MODIFICATION TO AVEA VENTILATOR (K073069) | Viasys Respiratory Care, Inc. | 2008-01-25 |
| LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT (K072607) | Irvine Scientific Sales Co., Inc. | 2008-01-25 |
| STALIF (TM) C (K072415) | Surgicraft , Ltd. | 2008-01-25 |
| BIOSET XCH (K072238) | Regeneration Technologies, Inc. | 2008-01-25 |
| G-TRAINER MEDICAL (K072887) | Alter-G, Inc. | 2008-01-25 |
| SAFESTEP MAX POWER-INJECTABLE INFUSION SET (K073050) | Specialized Health Products International, Inc. | 2008-01-25 |
| GLYCERIN & PARABEN FREE ASTROGLIDE (K072647) | Biofilm, Inc. | 2008-01-25 |
| INSUCOZI INSULIN VIAL COVER (K072174) | 41 Industries, LLC | 2008-01-25 |
| LANX INTERVERTEBRAL BODY FUSION DEVICE (K073144) | Lanx, LLC | 2008-01-24 |
| SKATER BILIARY CATHETER (K073672) | Angiotech | 2008-01-24 |
| DEPUY SIGMA PS FEMORAL COMPONENTS (K073529) | DePuy Orthopaedics, Inc. | 2008-01-24 |
| QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K073080) | Bio-Rad Laboratories | 2008-01-24 |
| LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 (K072596) | Amco International Manufacturing & Design, Inc. | 2008-01-24 |
| CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 (K072779) | Biolitec, Inc. | 2008-01-24 |
| ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 (K073441) | Possis Medical, Inc. | 2008-01-24 |
| ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 (K080024) | K2m, Inc. | 2008-01-24 |
| MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) (K072806) | Mako Surgical Corp. | 2008-01-24 |
| DSS (K072969) | Paradigm Spine, LLC | 2008-01-24 |
| BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR (K073654) | Blackstone Medical, Inc. | 2008-01-24 |
| 3VISEON/SURGERY (K072653) | 3Mensio Medical Imaging BV | 2008-01-24 |
| CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER (K072166) | The Binding Site | 2008-01-24 |
| SPERMCHECK VASECTOMY (K073039) | Princeton BioMeditech Corp. | 2008-01-24 |
| IMPLASA-HOECHST GMBH IMPLANTS (K071240) | Implasa-Hoechst GmbH | 2008-01-24 |
| P-NAIN SYSTEM (K072833) | Jeisys Medical, Inc. | 2008-01-24 |
| CRYSTAL (K073351) | Spinal Elements, Inc. | 2008-01-24 |
| CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K072777) | Ciba Vision Corporation | 2008-01-24 |