| SBI HAND FIXATION SYSTEM (TM) (K050462) | Small Bone Innovations, LLC | 2005-04-26 |
| MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 (K043380) | Monebo Technologies, Inc. | 2005-04-26 |
| DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX (K042526) | Medical Action Industries, Inc. | 2005-04-25 |
| PROOF POSITIVE ELECTRONIC PREGNANCY TEST (K043231) | Mizuho USA, Inc. | 2005-04-25 |
| ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR (K050387) | Roche Diagnostics Corp. | 2005-04-25 |
| ARIOL HER-2/NEU FISH (K043519) | Applied Imaging Corp. | 2005-04-25 |
| STAT MEDICAL PEN NEEDLE (K042917) | Emergogroup, Inc. | 2005-04-22 |
| BABYPAC (K043495) | Smiths Medical International Ltd., Luton | 2005-04-22 |
| SAFEPICO (K043143) | Radiometer Medical Aps | 2005-04-22 |
| 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT (K050712) | Bicon, Inc. | 2005-04-22 |
| COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE (K050578) | Cook Ireland, Ltd. | 2005-04-22 |
| PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 (K050762) | Philips Medizin Systeme Boeblingen GmbH | 2005-04-22 |
| STERRAD NX STERILIZER (K042116) | Advanced Sterilization Products | 2005-04-22 |
| DYRACT EXTRA RESTORATIVE (K050880) | Dentsply Intl. | 2005-04-22 |
| ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K043228) | Bayer Healthcare, LLC | 2005-04-22 |
| OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) (K050423) | Roche Diagnostics | 2005-04-22 |
| 21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB (K050617) | Totoku Electric Co., Ltd. | 2005-04-22 |
| PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 (K050777) | Conmedcorp | 2005-04-22 |
| SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS (K050636) | Synthes (Usa) | 2005-04-21 |
| NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 (K050772) | Image-Guided Neurologics, Inc. | 2005-04-21 |
| MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H (K050576) | Good Biotech Corp. | 2005-04-21 |
| KAVO ERGOCOM/ERGOCAM (K050744) | Kavo America Corporation | 2005-04-21 |
| CAMCERAM TCP (K050357) | Cam Implants B.V. | 2005-04-21 |
| STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 (K050615) | Stryker Instruments | 2005-04-21 |
| TRIAL CABLE RETENTION CLIP (K050633) | Advanced Neuromodulation Systems | 2005-04-21 |
| ACTICOAT MOISTURE CONTROL DRESSING (K050030) | Smith & Nephew, Inc. | 2005-04-21 |
| QBRAIN (K050703) | Medis Medical Imaging Systems BV | 2005-04-21 |
| LANDLEX, MODEL S300X (K050792) | Cycling and Health Tech. Industry R&D Center | 2005-04-21 |
| 21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB (K050616) | Totoku Electric Co., Ltd. | 2005-04-21 |
| ISCIENCE SURGICAL VISCOINJECTOR (K050716) | Iscience Surgical Corporation | 2005-04-21 |
| AGFA CR50.0 (K050810) | Agfa Corp. | 2005-04-21 |
| MEDELA SINGLE USE SILC CUP, MODEL 077.0791 (K041579) | Medela AG | 2005-04-21 |
| MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 (K043531) | K-Jump Health Co., Ltd. | 2005-04-21 |
| R. POON MEDICAL PRODUCTS WHEELCHAIRS (K050691) | R. Poon Medical Products Co., Ltd. | 2005-04-21 |
| VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM (K050588) | Innovative Spinal Design, LLC | 2005-04-21 |
| EUROCHAIR (K050560) | Meyra, Inc. | 2005-04-21 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K050404) | Intuitive Surgical, Inc. | 2005-04-21 |
| IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X (K050751) | Agfa Corp. | 2005-04-21 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT (K050725) | Ev3 Corporation | 2005-04-20 |
| URISCAN OPTIMA II URINE ANALYZER (K050801) | Yd Diagnostics | 2005-04-20 |
| SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS (K050580) | Smith & Nephew Endoscopy, Inc. | 2005-04-20 |
| ALL-IN-ONE (K050647) | Bisco, Inc. | 2005-04-20 |
| SURPASSON P5 NEWTRON (K050895) | Satelec | 2005-04-20 |
| MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS (K050723) | Zimmer, Inc. | 2005-04-20 |
| GROOVY IMPLANTS (K050258) | Nobel Biocare AB | 2005-04-19 |
| MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 (K050165) | Cyden Limited | 2005-04-19 |
| FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT (K050695) | Daavlin Distributing Co. | 2005-04-19 |
| KOLIBRI SPINE (K042721) | Brainlab AG | 2005-04-19 |
| SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM (K050724) | C.R. Bard, Inc. | 2005-04-18 |
| ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL (K043083) | Wrightmedicaltechnologyinc | 2005-04-18 |
| DOLPHIN INFLATION DEVICE (K042449) | Sedat S.A. | 2005-04-18 |
| WAGNER SL REVISION STEM LATERAL (K043356) | Zimmer Austin, Inc. | 2005-04-18 |
| DECAPINOL ORAL RINSE (DEN050001) | Sinclair Pharmaceuticals Limited | 2005-04-18 |
| BARDPORT TITANIUM PORTS (K050310) | Bard Access Systems, Inc. | 2005-04-18 |
| HYPERTRANSIT INFUSION CATHETER (K043538) | Cordis Neurovascular, Inc. | 2005-04-18 |
| LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000 (K050707) | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005-04-18 |
| NOVEL VBR SPINAL SYSTEM (K050553) | Alphatec/Nexmed | 2005-04-18 |
| POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) (K050122) | Smart Glove Corp. Sdn Bhd | 2005-04-18 |
| PAXGENE BLOOD RNA SYSTEM (DEN050003) | Preanalytix GmbH | 2005-04-18 |
| REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG (K043339) | Xtremi-T, LLC | 2005-04-18 |
| ONTRAK TESTCARD 9 (K050321) | Varian, Inc. | 2005-04-18 |
| THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 (K050101) | Zimmer Trabecular | 2005-04-15 |
| ARTHERX CORKSCREW FT II SUTURE ANCHOR (K050358) | Arthrex, Inc. | 2005-04-15 |
| MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 (K050699) | Amedica Corp. | 2005-04-15 |
| MATRIX STRETCH RESISTANT (SR) COILS (K050700) | Boston Scientific Corp | 2005-04-15 |
| TOMAS PIN (K042965) | Dentaurum, Inc. | 2005-04-15 |
| SPIRIT, MODEL HAS (K050153) | Caire, Inc. | 2005-04-15 |
| P&P SAFETY SYRINGE (K043419) | Medexel Medical Mfg. Co., Ltd. | 2005-04-15 |
| FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE (K043500) | Innospine, Inc. | 2005-04-15 |
| PENTADEFLUE IV SOLUTION ADMINISTRATION SETS (K041495) | Pentaferte S.P.A | 2005-04-15 |
| SPECTRA-SP CO2 LASER SYSTEM (K050254) | Max Engineering , Ltd. | 2005-04-15 |
| PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS (K050506) | Lifecore Biomedical, Inc. | 2005-04-15 |
| HOME-AWAY SYSTEM, MODEL 1041 (K042944) | In-X Corporation | 2005-04-15 |
| SMARTDOP 45 VASCULAR DOPPLER (K050601) | Koven Technology, Inc. | 2005-04-15 |
| HARMONY PORT SYSTEM, MODEL 1907 SERIES (K050706) | Spinal Concepts, Inc. | 2005-04-15 |
| MICROFLO-SAFE SCALP VEIN SET (K043328) | Dks Loversan Industria Biomedica Spa | 2005-04-15 |
| VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (K042927) | Greiner Bio-One Vacuette North America | 2005-04-15 |
| ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM (K042018) | Simply Clean Air & Water, Inc. | 2005-04-15 |
| KERR VPS IMPRESSION MATERIAL (K050604) | Sybron Dental Specialties, Inc. | 2005-04-15 |
| STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K043250) | Stryker Leibinger | 2005-04-15 |
| VEINNOVATIONS INFILTRATION SYSTEM (K050474) | Veinnovations, LLC | 2005-04-14 |
| MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT (K050770) | Mckinley Medical, LLC | 2005-04-14 |
| OCULIGHT GL/GLX (K050562) | Iridex Corp | 2005-04-14 |
| THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (K050511) | Vascular Solutions, Inc. | 2005-04-14 |
| VACULINK, MODEL VCL 3000 (K043614) | Medevco, Inc. | 2005-04-14 |
| CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA (K050532) | Spi Gloves Sdn. Bhd. | 2005-04-14 |
| QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 (K050769) | Z-Medica Corporation | 2005-04-14 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML (K050555) | Becton, Dickinson & CO | 2005-04-14 |
| CUMULASE (K042495) | Halozyme Therapeutics, Inc. | 2005-04-14 |
| SYNGO BODY PERFUSION-CT (K050867) | Siemens AG | 2005-04-14 |
| AQUAFLEX 2 (TEFILCON) CONTACT LENS (K050743) | Unilens Corp., USA | 2005-04-13 |
| TELEREHAD 2004 (K050778) | Scottcare | 2005-04-13 |
| JSZ-MULTIPURPOSE SOLUTION (K050517) | Szabocsik and Associates | 2005-04-13 |
| ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM (K050433) | Zimmer Orthopaedic Surgical Products | 2005-04-13 |
| REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S (K050046) | Compex Technologies, Inc. | 2005-04-13 |
| MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K050181) | Medigloves , Ltd. | 2005-04-13 |
| RELIANT STENT GRAFT BALLOON CATHETER (K050038) | Medtronic Endovascular Innovations | 2005-04-13 |
| SIC PRO (K040757) | Sic Invent AG | 2005-04-13 |
| OSOM HCG COMBO TEST (K043385) | Genzyme Diagnostics | 2005-04-12 |
| EVADRI BLADDER CONTROL SYSTEMS (K050483) | Hollister, Inc. | 2005-04-12 |