| POLAR CATH PERIPHERAL DILATATION SYSTEM (K051916) | Cryo Vascular Systems, Inc. | 2005-08-05 |
| OMNI SPHINCTEROTOME (K052051) | Wilson-Cook Medical, Inc. | 2005-08-05 |
| MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K052037) | Howmedica Osteonics Corp. | 2005-08-05 |
| CHARLOTTE SMALL MTP FUSION PLATE (K051884) | Wrightmedicaltechnologyinc | 2005-08-05 |
| 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 (K051949) | Triage Medical, Inc. | 2005-08-05 |
| COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (K043547) | Biomet, Inc. | 2005-08-05 |
| GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE (K051989) | Depuy Mitek, A Johnson & Johnson Company | 2005-08-05 |
| MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (K051983) | Axya Medical, Inc. | 2005-08-05 |
| PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS (K051322) | Smiths Medical International , Ltd. | 2005-08-05 |
| VERIFYNOW-P2Y12 ASSAY (K051231) | Accumetrics, Inc. | 2005-08-05 |
| SPLASH! IMPRESSION MATERIAL DEVICE (K052090) | Discus Dental, Inc. | 2005-08-05 |
| UGYTEX SUAL KNIT MESH (K051503) | Sofradim Production | 2005-08-05 |
| CLEVER CHEK TD-4225, MODEL TD-4225 (K051854) | Taidoc Technology Corporation | 2005-08-05 |
| TRICOT BLOOD PRESSURE CUFF (K051539) | Ya Horng Electronic Co., Ltd. | 2005-08-05 |
| EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE (K051385) | Biomet, Inc. | 2005-08-05 |
| METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 (K051042) | Angiometrx, Inc. | 2005-08-05 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML (K051689) | Becton, Dickinson & CO | 2005-08-05 |
| MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR (K050430) | Merits Health Products Co., Ltd. | 2005-08-04 |
| OPTIMA SPINAL SYSTEM (K051971) | U&I Corp. | 2005-08-04 |
| COBALT BONE CEMENT (K051496) | Biomet, Inc. | 2005-08-04 |
| INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 (K051362) | Inion OY | 2005-08-04 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K051601) | Terumo Medical Corp. | 2005-08-04 |
| INNER-LOCK INTRODUCER SHEATH (K051468) | Rex Medical | 2005-08-04 |
| ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (K051890) | Roche Diagnostics Corp. | 2005-08-04 |
| JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET (K051814) | Jms North America Corp. | 2005-08-04 |
| QUILL SYNTHETIC ABSORBABLE BARBED SUTURE (K051609) | Quill Medical, Inc. | 2005-08-04 |
| DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (K051660) | Coltene/Whaledent, Inc. | 2005-08-04 |
| VIEWSEND MEDICAL SYSTEM (K051586) | Kenei Co., Ltd. | 2005-08-04 |
| OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS (K043034) | Collagen Matrix, Inc. | 2005-08-04 |
| IMMUNALYSIS COCAINE ELISA FOR HAIR (K050465) | Immunalysis Corporation | 2005-08-04 |
| AMBU NEUROLINE GROUND (K051529) | Ambu, Inc. | 2005-08-04 |
| AMS PELVIC FLOOR REPAIR SYSTEM (K051485) | American Medical Systems, Inc. | 2005-08-03 |
| KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (K030146) | Kavo America | 2005-08-03 |
| BEAUTIFIL FLOW (K051818) | Shofu Dental Corp. | 2005-08-03 |
| ABBOTT AXSYM B12 (K051327) | Abbott Laboratories | 2005-08-03 |
| AVISO OPHTHALMIC ULTRASOUND SYSTEM (K051851) | Quantel Medical | 2005-08-03 |
| AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K050994) | Cardinalhealth | 2005-08-03 |
| POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K051378) | Medline | 2005-08-03 |
| CML 1000 (K051437) | Icu Medical, Inc. | 2005-08-03 |
| POWDER-FREE VINYL EXAM GLOVES (K052006) | Baoding Guanzhong Glove Co., Ltd. | 2005-08-03 |
| COBALT G HV BONE CEMENT (K051532) | Biomet, Inc. | 2005-08-03 |
| DIAGNODENT PERIO TIP (ACCESSORY) (K042394) | Kavo America Corporation | 2005-08-02 |
| SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 (K051045) | Spectrx, Inc. | 2005-08-02 |
| ACHIEVA 1.5T & INERA 1.5T FAMILY (K052013) | Philips Medical Systems Nederland B.V. | 2005-08-02 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051935) | Shijiazhuang Wonder Plastic Co., Ltd. | 2005-08-02 |
| VENTRI (K051855) | Ge Medical Systems F.I. Haifa | 2005-08-02 |
| GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM (K051285) | Infopia Co, Ltd. | 2005-08-02 |
| VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 (K051649) | Camtronics Medical Systems | 2005-08-02 |
| CARLO SURGICAL GOWN (K051426) | Sofilm Technology Co., Ltd. | 2005-08-02 |
| AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM (K051639) | As Software, Inc. | 2005-08-02 |
| STARPACS DENTAL (K051715) | Infinitt Co., Ltd. | 2005-08-02 |
| SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 (K051618) | Midwest Rf, LLC | 2005-08-02 |
| OSTEOCURE RESORBABLE BEAD KIT (K051406) | Nexa Orthopedics, Inc. | 2005-08-01 |
| POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING (K051683) | Shen Wei (Usa), Inc. | 2005-08-01 |
| MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR (K051939) | Medegen Medical Manufacturing System | 2005-08-01 |
| RT019 INSPIRATORY/EXPIRATORY FILTER (K050927) | Fisher & Paykel Healthcare, Ltd. | 2005-08-01 |
| ITAG MHC TETRAMER CMV ASSAY (K051122) | Beckman Coulter, Inc. | 2005-08-01 |
| LIPOPROTEIN FOR MULTIPLE ANALYTES (K051619) | Bayer Healthcare, LLC | 2005-08-01 |
| LENS PLUS REWETTING DROPS (K042562) | Advanced Medical Optics, Inc. | 2005-07-29 |
| HANS HERMANN LAPAROSCOPES AND ACCESSORIES (K051610) | Hans Hermann GmbH | 2005-07-29 |
| VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K051287) | Vascular Solutions, Inc. | 2005-07-29 |
| CLARIS NON-STICK BIPOLAR FORCEPS (K051429) | Guenter Bissinger Medizintechnik GmbH | 2005-07-29 |
| DYNAGRAFT II DENTAL (K043573) | Isotis Orthobiologics, Inc. | 2005-07-29 |
| T2 ANKLE ARTHRODESIS NAIL (K051590) | Howmedica Osteonics Corp. | 2005-07-29 |
| LTV 1000 VENTILATOR (K051767) | Pulmonetic Systems, Inc. | 2005-07-29 |
| INTRALASE FS LASER (K041893) | Intra Lase Corp. | 2005-07-29 |
| VITAL SIGNS MONITOR (K051375) | Mediana Co., Ltd. | 2005-07-28 |
| CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (K050808) | Cardio-Optics, Inc. | 2005-07-28 |
| AFT (K042125) | Musculoskeletal Transplant Foundation | 2005-07-28 |
| AXIOM EPS8000 (K050687) | Axiom Worldwide, Inc. | 2005-07-28 |
| QUEST DIAGNOSTICS HAIRCHECK-DT (PCP (K042726) | Quest Diagnostics, Inc. | 2005-07-28 |
| SPI EASY TEMPORARY CAP (K051527) | Thommen Medical AG | 2005-07-28 |
| POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. (K051739) | Multigon Industries, Inc. | 2005-07-28 |
| BIB PTA BALLOON CATHETER (K050857) | NuMED, Inc. | 2005-07-28 |
| MINI GHOST PTA CATHETER, MODEL 507 (K051343) | NuMED, Inc. | 2005-07-28 |
| BOSWORTH SEAL (K051224) | Harry J. Bosworth Co. | 2005-07-28 |
| MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS (K051773) | Medtronic Inc.,Neurological Division. | 2005-07-28 |
| BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (K042579) | The Binding Site | 2005-07-28 |
| ALLFIM IMPLANT SYSTEMS (K050635) | Cowellmedi Co., Ltd. | 2005-07-28 |
| JETLITE 5000 (K051780) | J. Morita USA, Inc. | 2005-07-28 |
| SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM (K051600) | Synthes (Usa) | 2005-07-27 |
| MALIBU SPINAL SYSTEM (K051942) | Seaspine, Inc. | 2005-07-27 |
| GRANDIO FLOW (K051868) | Voco GmbH | 2005-07-27 |
| THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM (K051845) | Bioplate, Inc. | 2005-07-27 |
| MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ (K051756) | Zimmer Trabecular | 2005-07-27 |
| MS 9/5 HEMATOLOGY ANALYZER (K050436) | Melet Schloesing Laboratories USA | 2005-07-27 |
| MEDICINELODGE ZIPKNOT (K051488) | Medicinelodge, Inc. | 2005-07-27 |
| SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 (K051581) | Sanarus Medical, Inc. | 2005-07-27 |
| S4 SPINAL SYSTEM (K050979) | Aesculap, Inc. | 2005-07-27 |
| ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES (K051509) | Erbe USA, Inc. | 2005-07-27 |
| TRABECULAR METAL REVISION SHELL LINERS (K051516) | Zimmer, Inc. | 2005-07-27 |
| EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 (K051631) | Stargate International, Inc. | 2005-07-27 |
| ALEUTIAN SPACER SYSTEM (K051454) | K2m, LLC | 2005-07-27 |
| THE EDGE DETECTOR, MODEL 1118 (K051921) | Sun Nuclear Corp. | 2005-07-27 |
| XIA 4.5 SPINAL SYSTEM (K050461) | Stryker Spine | 2005-07-27 |
| MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN (K051478) | Dade Behring, Inc. | 2005-07-27 |
| GRANDIO (K051867) | Voco GmbH | 2005-07-27 |
| CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER (K050463) | Taidoc Technology Corporation | 2005-07-27 |
| MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION (K050651) | Medtronic Navigation, Inc. | 2005-07-27 |
| MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY (K051506) | Sterylab S.R.L. | 2005-07-27 |