| ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM (K042092) | Zeus Scientific, Inc. | 2005-04-12 |
| REPROCESSED HARMONIC SCALPELS (K050343) | Sterilmed, Inc. | 2005-04-12 |
| SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR (K043555) | Synthes (Usa) | 2005-04-12 |
| GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) (K050676) | Datex-Ohmeda, Inc. | 2005-04-12 |
| AURORA DS, DS APPLICATOR (K050796) | Syneron Medical, Ltd. | 2005-04-12 |
| STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A (K050831) | Stellartech Research Corp. | 2005-04-12 |
| LANX ANTERIOR CERVICAL PLATE SYSTEM (K050774) | Lanx, LLC | 2005-04-11 |
| OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER (K050490) | Medicrea | 2005-04-11 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K043053) | Medtronic Sofamor Danek | 2005-04-11 |
| STRYKER SPINE AVS PL PEEK SPACER (K050624) | Stryker Spine | 2005-04-11 |
| ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM (K050761) | Zimmer, Inc. | 2005-04-11 |
| TRANSPORT SERIES TRANSPORT CHAIR (K050281) | Access Point Medical, LLC | 2005-04-11 |
| ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER (K042565) | Ortho Development Corp. | 2005-04-11 |
| RUNABOUT WHEELCHAIR (K050280) | Access Point Medical, LLC | 2005-04-11 |
| EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE (K050675) | Depuy Spine, Inc. | 2005-04-11 |
| AXS-1 LITE WHEELCHAIR (K050279) | Access Point Medical, LLC | 2005-04-11 |
| PLIX (K050414) | Respironics, Inc. | 2005-04-11 |
| MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM (K050804) | Aesculap, Inc. | 2005-04-11 |
| SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) (K050607) | Synthes (Usa) | 2005-04-11 |
| CHARLOTTE SNAP-OFF SCREW (K050819) | Wrightmedicaltechnologyinc | 2005-04-11 |
| SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION (K050631) | Synthes (Usa) | 2005-04-11 |
| GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES (K050666) | Berkeley Advanced Biomaterials, Inc. | 2005-04-11 |
| GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR (K050193) | Louis M. Gerson Co., Inc. | 2005-04-11 |
| LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE (K050765) | N.S. Uni-Gloves Sdn. Bhd. | 2005-04-08 |
| DUREX PLAY TINGLING LUBRICANT (K042958) | Ssl Americas, Inc. | 2005-04-08 |
| ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE (K043529) | Roche Diagnostics Corp. | 2005-04-08 |
| FLXIS (K050692) | Philips Medical Systems North America Co. | 2005-04-08 |
| TRAXYLOC-1 SYSTEM (K050663) | Traxyz Medical, Inc. | 2005-04-08 |
| VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (K043253) | Vanguard Medical Concepts, Inc. | 2005-04-08 |
| MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING (K050704) | General Electric Co. | 2005-04-08 |
| ONE STEP HCG URINE PREGNANCY TEST (K043443) | Guangzhou Wondfo Biotech Co., Ltd. | 2005-04-08 |
| BLOOD GLUCOSE MONITORING SYSTEM (K043543) | American Healthcare, Inc. | 2005-04-08 |
| HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL (K050622) | Mri Devices Corporation | 2005-04-08 |
| MALE NATURAL RUBBER LATEX CONDOM (K050244) | Nrs Global Partners | 2005-04-08 |
| LUPINE LOOP (K050771) | Depuy Mitek, A Johnson & Johnson Company | 2005-04-08 |
| EASYGLUCO IGM-0002 G2 (K043512) | American Healthcare, Inc. | 2005-04-08 |
| BLOOD-PRESSURE METER, BPW120 (K050083) | Idt Technology Limited | 2005-04-08 |
| TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE (K041515) | Sutures India Private Limited | 2005-04-08 |
| SPOR-TEST PA BIOLOGICAL INDICATOR KIT (K050664) | Getinge USA, Inc. | 2005-04-07 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT (K050711) | Health & Life Co., Ltd. | 2005-04-07 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS (K050714) | Health & Life Co., Ltd. | 2005-04-07 |
| ZOLL E SERIES DEFIBRILLATOR (K042007) | Zoll Medical Corp | 2005-04-07 |
| PROWIN (K050376) | Medical Technologies International, Inc. | 2005-04-07 |
| ZYGOMA TIUNITE (K050641) | Nobel Biocare USA, LLC | 2005-04-07 |
| ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (K042411) | Axis-Shield , Ltd. | 2005-04-07 |
| BD POSIFLOW POSITIVE DISPLACEMENT VALVE (K050207) | Becton Dickinson Infusion Therapy Systems, Inc. | 2005-04-07 |
| SURGITRON RADIOLASE II (K042710) | Ellman Int'L, Inc. | 2005-04-07 |
| ANSPACH COUPLER (K050628) | The Anspach Effort, Inc. | 2005-04-07 |
| NBD HEAD SCREW (K050377) | New Business Development, LLC | 2005-04-07 |
| NVA-127-8-A NEUROVASCULAR ARRAY COIL (K050621) | Mri Devices Corporation | 2005-04-07 |
| ALTAIRE (K050602) | Hitachi Medical Systems America, Inc. | 2005-04-07 |
| 20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB) (K050485) | Totoku Electric Co., Ltd. | 2005-04-07 |
| POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) (K050598) | Smart Glove Corp. Sdn Bhd | 2005-04-07 |
| BICON ORTHODONTIC IMPLANT SYSTEM (K050408) | Bicon, Inc. | 2005-04-07 |
| HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM (K050225) | Cambridge Heart, Inc. | 2005-04-07 |
| MICROWARE 200 (K050740) | Microware, Inc. | 2005-04-06 |
| SPOTCHEM II CREATININE, AMYLASE & ALP TESTS (K050652) | Arkray, Inc. | 2005-04-06 |
| ENDOTINE RIBBON (K050611) | Coapt Systems, Inc. | 2005-04-06 |
| MODIFICATION TO BVBLUE (K050755) | Gryphus Diagnostics, LLC | 2005-04-06 |
| SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) (K050606) | Synthes (Usa) | 2005-04-06 |
| DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES (K043539) | Demetech Corp. | 2005-04-06 |
| LC BRACKET ADHESIVE SYSTEM (K050750) | Dentsply Intl. | 2005-04-06 |
| TEGRESS IMPLANT NEEDLE (K050688) | C.R. Bard, Inc. | 2005-04-06 |
| SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (K050648) | Advanced Medical Optics, Inc. | 2005-04-05 |
| OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N (K042505) | Omron Healthcare, Inc. | 2005-04-05 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM (K050587) | Health & Life Co., Ltd. | 2005-04-05 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 (K050742) | Philips Medical Systems | 2005-04-05 |
| ICC INSULIN SAFEPRO SAFETY SYRINGE (K050134) | Formosa Medical Devices, Inc. | 2005-04-05 |
| RELIEVA SINUS BALLOON DILATION CATHETER (K043527) | Exploramed Nc1, Inc. | 2005-04-05 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K050614) | Ge Medical Systems Information Technologies | 2005-04-05 |
| OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M (K042506) | Omron Healthcare, Inc. | 2005-04-05 |
| DEPOTONE (K050505) | Imprint Pharmaceuticals Limited | 2005-04-05 |
| BONE BLOCK FIXATION SET (K050515) | Straumann USA, Inc. | 2005-04-05 |
| HEALTH BUDDY APPLIANCE (K050567) | Health Hero Network, Inc. | 2005-04-05 |
| HL 200 ELECTRONIC STETHOSCOPE (K050169) | Health & Life Co., Ltd. | 2005-04-05 |
| VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 (K043503) | Visx, Incorporated | 2005-04-05 |
| INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE (K050131) | M.K. Meditech Co. , Ltd. | 2005-04-05 |
| DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM (K042470) | Ssl Americas, Inc. | 2005-04-05 |
| MICROLUX DL (K041614) | Addent, Inc. | 2005-04-04 |
| SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES (K050450) | Zibo Blue Intco Plastic & Rubber Products Co., Ltd. | 2005-04-04 |
| CIDEX OPA CONCENTRATE (K032959) | Advanced Sterilization Products | 2005-04-04 |
| AIDA WITH DICOM AND HL7 INTERFACE (K043324) | KARL STORZ Endoscopy-America, Inc. | 2005-04-04 |
| SURGICAL DESIGN CIRCUMCISION CLAMP (K043533) | Surgical Design, Inc. | 2005-04-01 |
| ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM (K050671) | Surgrx, Inc. | 2005-04-01 |
| CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS (K050548) | Surgical Specialties Corp | 2005-04-01 |
| TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES (K050488) | Prosurg, Inc. | 2005-04-01 |
| QMS VANCOMYCIN (K050419) | Seradyn, Inc. | 2005-04-01 |
| BLOOD HAND PUMP ADMINISTRATION SET (K050115) | Cardinal Health, Alaris Products | 2005-04-01 |
| MDA B.30 (K050513) | bioMerieux, Inc. | 2005-04-01 |
| CORDIS AMIIA .014 PTA BALLOON CATHETER (K050645) | Cordis Corp. | 2005-04-01 |
| THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 (K050701) | Bionix Development Corp. | 2005-04-01 |
| ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (K050510) | Shimadzu Medical Systems | 2005-04-01 |
| CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (K050172) | Cardiomedics, Inc. | 2005-03-31 |
| CUTERA SOLERA OPUS AESTHETIC PRODUCT (K050679) | Cutera, Inc. | 2005-03-31 |
| MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 (K050319) | Integra Lifesciences Corp. | 2005-03-31 |
| COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH (K043418) | Cook Urological, Inc. | 2005-03-31 |
| VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (K043594) | Vanguard Medical Concepts, Inc. | 2005-03-31 |
| NEOTHERMIA EN-BLOC BIOPSY SYSTEM (K050737) | Neothermia Corporation | 2005-03-31 |
| H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF (K050491) | Health & Life Co., Ltd. | 2005-03-31 |
| GRAFTSAVER (K043515) | Vescare, Inc. | 2005-03-31 |