| PORTRAIT FEMORAL COMPONENT (K010560) | Biomet, Inc. | 2001-03-20 |
| LACTOSORB 5.0 MM WASHER (K001581) | Biomet, Inc. | 2001-03-20 |
| ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION (K001535) | Ortho Tec, LLC | 2001-03-20 |
| WRISTWATCH BLOOD PRESSURE MONITOR A46 (K010498) | Rossmax Internationl , Ltd. | 2001-03-20 |
| NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (K010031) | Wescor, Inc. | 2001-03-20 |
| MODIFICATION TO ITI DENTAL IMPLANT SYSTEM (K003271) | Institut Straumann AG | 2001-03-20 |
| MODIFICATION TO LAP TOP VENTILATOR (LTV) (K010608) | Pulmonetic Systems, Inc. | 2001-03-20 |
| SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER (K010640) | Siemens Medical Solutions USA, Inc. | 2001-03-20 |
| MODIFICATION TO TRIDENT ALL POLY CUP (K010310) | Howmedica Osteonics Corp. | 2001-03-20 |
| PM 1800 CONSERVING DEVICE (K001412) | Precision Medical, Inc. | 2001-03-20 |
| RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (K010052) | Respironics, Inc. | 2001-03-19 |
| MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD (K003979) | Medtrade Products , Ltd. | 2001-03-19 |
| XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP (K010087) | Excel Tech. , Ltd. | 2001-03-19 |
| C1-INHIBITOR MICROTITER ASSAY DEVICE (K003747) | Baxter Healthcare Corp | 2001-03-19 |
| ACCU-CHEK INFORM METER (K003846) | Roche Diagnostics Corp. | 2001-03-19 |
| BAUMER CEMENTED HIP PROSTHESIS (K003975) | Baumer, S.A | 2001-03-19 |
| TRIFIX SPINAL FIXATION SYSTEM (K010535) | Endius, Inc. | 2001-03-19 |
| NEOLYNX SCREENING APPLICATION MANAGER (K003584) | Micromass, Inc. | 2001-03-19 |
| SUPER REVO SUTURE ANCHOR (K003984) | Linvatec Corp. | 2001-03-19 |
| WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120 (K002665) | K-Jump Health Co., Ltd. | 2001-03-19 |
| BAUMER MULLER HIP PROSTHESIS (K003976) | Baumer, S.A | 2001-03-19 |
| STERILE SUBDERMAL NEEDLE ELECTRODES (K010019) | Nicolet Biomedical, Inc. | 2001-03-19 |
| MICROWAVAE DELIVERY SYSTEM #MW2000 (K010589) | Mw Medical, Inc. | 2001-03-19 |
| NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS (K003910) | Zimmer, Inc. | 2001-03-19 |
| NPAC MULTI-USE THERMOMETER, MODEL TD400 (K010224) | Norm Pacific Automation Corp. | 2001-03-18 |
| 4 PORT, 4 WAY STOPCOCK (K010217) | George Loo, MD | 2001-03-18 |
| HINT AUDIOMETER, OR HINT (K003913) | Maico-Diagnostics | 2001-03-16 |
| INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 (K003953) | Ethicon Endo-Surgery, Inc. | 2001-03-16 |
| MD 30 COMPACT (K004014) | General Project | 2001-03-16 |
| E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS) (K003449) | Ulrich Alber GmbH & Co. | 2001-03-16 |
| MRI SAFE INSTRUMENTS (K003965) | Aesculap, Inc. | 2001-03-16 |
| BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) (K010223) | American Contact Lens, Inc. | 2001-03-16 |
| SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (K010287) | Scimedx Corp. | 2001-03-16 |
| VISTAKON (HEFILCON C) CONTACT LENSES (K010218) | Vistakon | 2001-03-16 |
| SPECULITE/ORALLITE (K003995) | Trylon Corp. | 2001-03-16 |
| PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM (K010445) | Cordis Corp. | 2001-03-16 |
| INDIGO LASEROPTIC TREATMENT SYSTEM (K003952) | Ethicon Endo-Surgery, Inc. | 2001-03-16 |
| DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 (K010206) | Dade Behring, Inc. | 2001-03-16 |
| SAFARI (K010606) | Ranger All Season Corp. | 2001-03-16 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 (K010266) | Biosite Incorporated | 2001-03-16 |
| ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI (K002706) | Roche Diagnostics Corp. | 2001-03-16 |
| REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP (K010084) | Excel Tech. , Ltd. | 2001-03-16 |
| COOK PRESSURE MONITORING CATHETER (K002254) | Cook, Inc. | 2001-03-16 |
| ACCUSONIC, MODEL AS-260 (K010609) | Metron Medical Australia, Pty, Ltd. | 2001-03-16 |
| MN-4 COARSE MANIPULATOR (K010298) | Narishige Co., Ltd. | 2001-03-16 |
| CBC-SF (K010409) | R&D Systems, Inc. | 2001-03-16 |
| INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM (K010351) | Inion , Ltd. | 2001-03-15 |
| RANDOX GLUCOSE (GOD/PAP) (K003346) | Randox Laboratories, Ltd. | 2001-03-15 |
| LASEREX INTEGRE, MODEL LP2532 (K003955) | Ellex Medical Pty, Ltd. | 2001-03-15 |
| DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES (K010463) | Datex-Ohmeda, Inc. | 2001-03-15 |
| SPIFE IFE CALIBRATOR AND CONTROL KIT (K010617) | Helena Laboratories | 2001-03-15 |
| MODIFICATION TO ACTICOAT FOAM DRESSING (K010447) | Westaim Biomedical, Inc. | 2001-03-15 |
| ULTRAPAK NEHA (K010070) | Ultradent Products, Inc. | 2001-03-15 |
| SURSHIELD WINGED INFUSION SET (K010103) | Terumo Medical Corp. | 2001-03-15 |
| EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) (K010085) | Excel Tech. , Ltd. | 2001-03-15 |
| MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 (K003344) | Medical Depot, Inc. | 2001-03-15 |
| IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM (K003899) | Mri Devices Corp. | 2001-03-15 |
| WISEBANDS SKIN CLOSURE DEVICE (K002315) | Wisebands , Ltd. | 2001-03-15 |
| PANASONIC TELE-HOMECARE SYSTEM (K004050) | Matsushita Electric Industrial Co., Ltd. | 2001-03-15 |
| OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER (K010591) | Olympus Optical Co., Ltd. | 2001-03-15 |
| NEMIO (K010631) | Toshiba America Medical Systems, In.C | 2001-03-15 |
| GALIX GBI -3S-LP (K992706) | Galix Biomedical Instrumentation, Inc. | 2001-03-15 |
| LORENZ FIDUCAIL SCREW (K010427) | Walter Lorenz Surgical, Inc. | 2001-03-15 |
| EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) (K010425) | Hdc Corp. | 2001-03-15 |
| N PROTEIN STANDARD UY CALIBRATOR (K003501) | Dade Behring, Inc. | 2001-03-15 |
| YORAMED, MODEL T-202 (K002297) | United Yoram Distributors, Inc. | 2001-03-15 |
| ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) (K003557) | ACON Laboratories, Inc. | 2001-03-15 |
| MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (K010523) | Binax, Inc. | 2001-03-15 |
| PLANMED SOPHIE, PLANMED SOPHIE CLASSIC (K010116) | Planmed OY | 2001-03-15 |
| SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (K003267) | Sigma Diagnostics, Inc. | 2001-03-15 |
| DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER (K003301) | CellaVision AB | 2001-03-15 |
| DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND (K010061) | Dade Behring, Inc. | 2001-03-14 |
| Y2000 POCKET RESCUE (K010191) | Cheen Houng Ent. Co. , Ltd. | 2001-03-14 |
| CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM (K010352) | Inion , Ltd. | 2001-03-14 |
| SMOOTH-FLO CIRCUIT (K010402) | Hudson Respiratory Care, Inc. | 2001-03-14 |
| INNOVO (K010359) | Novo Nordisk A/S | 2001-03-14 |
| 'ALL 2000' % OXYGEN ANALYZER (K002382) | Analytical Industries, Inc. | 2001-03-14 |
| BIOSORBFX AND BIOSORBPDX MESH (K010687) | Bionx Implants, Inc. | 2001-03-14 |
| O2/CO2 NASAL FILTERLINE (K010024) | Oridion Medical 1987 , Ltd. | 2001-03-14 |
| PRONEB ULTRA MODEL NUMBER 85B0100 (K002862) | Pari Holding Co. | 2001-03-13 |
| 3D-DOCTOR (K003746) | Able Software Corp. | 2001-03-13 |
| STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM (K010062) | Arplay Medical S.A. | 2001-03-13 |
| ALPHA DX SYSTEM (K010562) | First Medical, Inc. | 2001-03-13 |
| BEAM BLOCK TRAYS (K004015) | Arplay Medical S.A. | 2001-03-13 |
| OPTETRAK B-SERIES TOTAL KNEE SYSTEM (K010434) | Exactech, Inc. | 2001-03-13 |
| LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (K003614) | Coherent Star | 2001-03-13 |
| N LATEX CYSTATIN C (K003503) | Dade Behring, Inc. | 2001-03-13 |
| MODIFICATION TO EBI XFIX DFS RAIL SYSTEM (K010437) | Ebi, L.P. | 2001-03-13 |
| GRAMSORB SYNTHETIC ABSORBABLE SUTURE (K003017) | Gramsmed, LLC | 2001-03-13 |
| MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM (K001353) | Biomedical Ent., Inc. | 2001-03-13 |
| TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) (K003911) | Terray Corp. | 2001-03-13 |
| FUNCTIONAL BRAIN MAPPING OPTION FOR MRI (K003947) | GE Medical Systems | 2001-03-13 |
| SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) (K010373) | Sterling Medivations, Inc. | 2001-03-13 |
| ULTRASONIC NEBULIZER, MODEL NE-520 (K002153) | Medisana USA, Inc. | 2001-03-13 |
| ASPIRE COVERED STENT AND DELIVERY CATHETER (K003173) | Vascular Architects, Inc. | 2001-03-13 |
| ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 (K010428) | Beckman Coulter, Inc. | 2001-03-13 |
| 7230 ULTRASOUND IMAGING SYSTEM WITH TEI (K010405) | Biosound Esaote, Inc. | 2001-03-13 |
| MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM (K001354) | Biomedical Ent., Inc. | 2001-03-13 |
| PHILIPS BV PULSERA/ENDURA (K010435) | Philips Medical Systems, Inc. | 2001-03-12 |
| FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM (K003837) | Ge Oec Medical Systems | 2001-03-12 |