| MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE (K013556) | Tyco Healthcare | 2001-12-31 |
| STRYKER PAINPUMP (K014091) | Stryker Corp. | 2001-12-31 |
| REMEDY MODEL 2Z12 (K012029) | Apollo Corp. | 2001-12-31 |
| MSI BIPOLAR SHEATH (K011202) | Medical Scientific, Inc. | 2001-12-31 |
| AUROPAL, ORDER-NO.: 2101 (K012839) | Wieland Edelmetalle GmbH & Co. | 2001-12-31 |
| POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) (K013942) | Wrp Specialty Products Sdn. Bhd. | 2001-12-31 |
| SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (K013721) | CIVCO Medical Instruments Co., Inc. | 2001-12-28 |
| MAGNETOM TRIO SYSTEM (K013586) | Siemens Medical Systems, Inc. | 2001-12-28 |
| BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY (K012183) | Bayer Diagnostics Corp. | 2001-12-27 |
| KIMSTIM AURICULAR ELECTRODE (K011691) | Kim Institute For Rehabilitation Medicine, P.C. | 2001-12-27 |
| MODIFICATION TO TSRH SPINAL SYSTEM (K014076) | Medtronic Sofamor Danek, Inc. | 2001-12-27 |
| PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS (K013991) | Zimmer, Inc. | 2001-12-27 |
| BIOTEQUE VAGINAL PESSARIES (K013289) | Bioteque America, Inc. | 2001-12-27 |
| LONG TROCHANTERIC NAIL SYSTEM (K013563) | DePuy Orthopaedics, Inc. | 2001-12-27 |
| AVALON CUP SYSTEM (K011887) | Orthopedic Source, Inc. | 2001-12-27 |
| D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER (K013915) | Dideco S.P.A. | 2001-12-27 |
| VICTORCH MEDITEK'S HCG TEST CARD (K013678) | Victorch Meditek, Inc. | 2001-12-27 |
| FOTONA DUALIS, FOTONA DUALIS PLUS (K011939) | Fotona D.D. | 2001-12-27 |
| VICTORCH HCG TEST STRIP (K013702) | Victorch Meditek, Inc. | 2001-12-27 |
| SPINAL MESH SYSTEM (K011406) | Medtronic Sofamor Danek, Inc. | 2001-12-27 |
| SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS (K013649) | Sauflon Pharmaceuticals, Ltd. | 2001-12-26 |
| INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE (K013225) | Medafor, Inc. | 2001-12-26 |
| OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES (K013445) | Florida Optical Engineering, Inc. | 2001-12-26 |
| CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M (K011589) | Bypass , Ltd. | 2001-12-26 |
| SOLO-CARE PLUS MULTIPURPOSE SOLUTION (K012731) | Ciba Vision Corporation | 2001-12-26 |
| XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT (K013591) | Olympus Optical Co., Ltd. | 2001-12-26 |
| SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (K013549) | Sigma Diagnostics, Inc. | 2001-12-26 |
| ABUSCREEN ONLINE OPIATES 300 / 2000 (K013482) | Roche Diagnostics Corp. | 2001-12-21 |
| MODIFICATION TO: INJECTABLE MIMIX (K012569) | Biomet, Inc. | 2001-12-21 |
| ULTRA -THIN SDS BALLOON DILATATION CATHETER (K011889) | Boston Scientific Corp | 2001-12-21 |
| GLO-SPEC (K013817) | Sol Weiss MD, Inc. | 2001-12-21 |
| INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE (K013800) | Becton Dickinson Infusion Therapy Systems, Inc. | 2001-12-21 |
| MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL (K013995) | Medical Analysis Systems, Inc. | 2001-12-21 |
| MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (K013527) | Synthes (Usa) | 2001-12-21 |
| VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE (K011832) | Vanguard Medical Concepts, Inc. | 2001-12-21 |
| DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (K013628) | Diamedix Corp. | 2001-12-21 |
| NORMATEC PCD (K013436) | Normatec, Inc. | 2001-12-21 |
| ACS 180 HOMOCYSTEINE ASSAY (K013606) | Bayer Diagnostics Corp. | 2001-12-21 |
| STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE (K013850) | Diamond Diagnostics, Inc. | 2001-12-21 |
| MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE (K013193) | Biolitec, Inc. | 2001-12-21 |
| UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K013900) | Ortho-Clinical Diagnostics | 2001-12-21 |
| SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466) | Helena Laboratories | 2001-12-21 |
| DIGIPAN / DPI (K012514) | Trophy Radiologie | 2001-12-21 |
| GELCLAIR CONCENTRATED ORAL GEL (K013056) | Sinclair Pharmaceuticals, Ltd. | 2001-12-21 |
| BIOSCANNER PLUS (K014099) | Polymer Technology Systems, Inc. | 2001-12-21 |
| WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 (K013652) | Wiener Laboratories Saic | 2001-12-21 |
| LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) (K011960) | Lares Research, Inc. | 2001-12-21 |
| AST (SGOT) (K013698) | Jas Diagnostics, Inc. | 2001-12-21 |
| VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX (K011702) | Vertis Neuroscience, Inc. | 2001-12-21 |
| ENTEGRA PE PERSONAL DIGITAL ASSISTANT (K014058) | General Electric Medical Systems | 2001-12-21 |
| CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K013568) | Bayer Corp. | 2001-12-21 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES (K013925) | Trek Diagnostic Systems, Inc. | 2001-12-21 |
| WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA (K011953) | Wiener Laboratories Saic | 2001-12-21 |
| FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II (K013218) | Fujifilm Medical System U.S.A., Inc. | 2001-12-20 |
| GLUSITE, MODEL GLU002 (K013446) | Glustitch, Inc. | 2001-12-20 |
| SIGN IM NAIL (K013132) | Surgical Implant Generation Network (Sign) | 2001-12-20 |
| PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL (K013172) | Porges S.A. | 2001-12-20 |
| NORIAN SRS BONE VOID FILLER (K011897) | Synthes (Usa) | 2001-12-20 |
| OXYLOG 1000, MODEL 2M86840 (K010793) | Drager Medizintechnik GmbH | 2001-12-20 |
| EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (K013226) | Evenflo Company, Inc. | 2001-12-20 |
| FRIALIT-2 ESTHETICBASE ABUTMENT (K013438) | Friadent GmbH | 2001-12-20 |
| LORENZ LACTOSORB PANELS AND FASTENERS (K011139) | Biomet, Inc. | 2001-12-20 |
| FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE (K013273) | Fukuda Denshi USA, Inc. | 2001-12-20 |
| BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM (K012323) | Respironics, Inc. | 2001-12-20 |
| HAND-CARRIED ULTRASOUND SYSTEM (K014116) | Sonosite,Inc. | 2001-12-20 |
| INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND (K013424) | Hand Innovations, Inc. | 2001-12-20 |
| GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES (K012660) | Gimmi GmbH | 2001-12-20 |
| MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (K013901) | Cardiofocus, Inc. | 2001-12-20 |
| CSIST DICOM GATEWAY/IMAGE MANAGER (K012327) | Csist | 2001-12-20 |
| NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM (K013419) | Nicolet Biomedical | 2001-12-20 |
| AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K013512) | Ciba Vision Corporation | 2001-12-20 |
| FILTERFLO H (K011212) | Arc Medical, Inc. | 2001-12-20 |
| VENTLAB HYPERINFLATION BAG SYSTEM (K013308) | Ventlab Corp. | 2001-12-20 |
| GELBISH VASCULAR DILATOR (K012256) | Vascumetrix, LLC | 2001-12-20 |
| RT-PLUS KNEE ADDITIONAL COMPONENTS (K013340) | Plus Orthopedics | 2001-12-20 |
| 3D LINE STEROTACTIC HARDWARE ACCESSORIES (K011255) | 3D Line USA, Inc. | 2001-12-20 |
| TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING (K013475) | Howmedica Osteonics Corp. | 2001-12-20 |
| MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (K013916) | Cook, Inc. | 2001-12-20 |
| BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K013377) | Ocular Sciences Puerto Rico, Inc. | 2001-12-20 |
| SAUFLON MULTI LENS CARE SYSTEM (K010559) | Sauflon Pharmaceuticals, Ltd. | 2001-12-20 |
| MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM (K013449) | Disc-O-Tech Medical Technologies, Ltd. | 2001-12-19 |
| MEDPOR COATED TEAR DRAIN (K012108) | Porex Surgical, Inc. | 2001-12-19 |
| DIGICAP (K012199) | Humana USA, Inc. | 2001-12-19 |
| SYNTHES LCP DISTAL TIBIA PLATES (K013248) | Synthes (Usa) | 2001-12-19 |
| ANISEIKONIA INSPECTOR (K013110) | Optical Diagnostics, Inc. | 2001-12-19 |
| GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE (K013346) | W. L. Gore & Associates, Inc. | 2001-12-19 |
| MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM (K013829) | Medtronic Sofamor Danek, Inc. | 2001-12-19 |
| XIA SPINAL SYSTEM (K013823) | Howmedica Osteonics Corp. | 2001-12-19 |
| AUTO SUTURE SURGICAL STAPLES (K013860) | United States Surgical, A Division of Tyco Healthc | 2001-12-19 |
| MICROGYN PLUS STIMULATION DEVICE (K013141) | Hollister, Inc. | 2001-12-19 |
| POLARUS CAP SCREW (K013616) | Acu Med, Inc. | 2001-12-19 |
| ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER (K013989) | Smith & Nephew, Inc. | 2001-12-19 |
| BLUE LATEX EXAMINATION GLOVES, POWDER FREE (K013320) | Arista Latindo Industrial Ltd. P.T | 2001-12-19 |
| PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM (K013798) | Institut Straumann AG | 2001-12-19 |
| MULTITAK SUTURE SNAP SYSTEM (K013177) | Bonutti Research, Inc. | 2001-12-19 |
| GENERATION 4 BONE CEMENT (K993836) | Biomet, Inc. | 2001-12-19 |
| AUROFLUID PLUS (K013505) | Metalor Technologies USA | 2001-12-19 |
| PRE-LOADED ULTRAFIX RC (K013553) | Linvatec Corp. | 2001-12-19 |
| CODMAN SLIM-LOC SYSTEM (K013877) | Codman & Shurtleff, Inc. | 2001-12-19 |