| GEBAUER'S INSTANT ICE (K021726) | Gebauer Co. | 2002-12-12 |
| INTRAUTERINE DELIVERY SYSTEM - INJECTOR (K023051) | Prosurg, Inc. | 2002-12-12 |
| REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH (K023328) | Center For Biomaterials and Advanced Technologies | 2002-12-12 |
| OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC (K021682) | Omron Healthcare, Inc. | 2002-12-12 |
| ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 (K023147) | Bortec Biomedical, Ltd. | 2002-12-12 |
| METHADONE ENZYME IMMUNOASSAY (K023317) | Lin-Zhi International, Inc. | 2002-12-12 |
| UNIDUS MALE LATEX CONDOM (K023059) | Unidus Corp. | 2002-12-12 |
| ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D (K023886) | Erbe USA, Inc. | 2002-12-12 |
| SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) (K023957) | Sonosite,Inc. | 2002-12-12 |
| K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) (K023770) | Kinetikos Medical, Inc. | 2002-12-12 |
| AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE (K013562) | Baxter Healthcare Corp | 2002-12-12 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K023180) | Vanguard Medical Concepts, Inc. | 2002-12-12 |
| CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER (K023880) | ETHICON, Inc. | 2002-12-11 |
| BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 (K023330) | Diagnostic Chemicals , Ltd. | 2002-12-11 |
| W.O.M. LASER U100 (K023041) | W.O.M. World of Medicine AG | 2002-12-11 |
| SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE (K023923) | Senorx, Inc. | 2002-12-11 |
| ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM (K023299) | Alphatec Mfg., Inc. | 2002-12-11 |
| GE PHOTON ENERGY RECOVERY (PER) OPTION (K023932) | Ge Medical Systems F.I. Haifa | 2002-12-11 |
| ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 (K023777) | Arthronet Medical, Inc. | 2002-12-11 |
| MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803) | Biotronik, Inc. | 2002-12-11 |
| COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER (K023379) | Cooper Surgical | 2002-12-11 |
| SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (K023232) | Smartpractice | 2002-12-11 |
| KSEA DEPLOYABLE CARDIOVASCULAR CLAMP (K014277) | KARL STORZ Endoscopy-America, Inc. | 2002-12-11 |
| NXSTAGE CARTRIDGE EXPRESS (K014152) | Nxstage Medical, Inc. | 2002-12-11 |
| ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY (K023597) | Beckman Coulter, Inc. | 2002-12-11 |
| PRESS-FIT HEAD RESURFACING DEVICE (K023188) | Biomet Orthopedics, Inc. | 2002-12-11 |
| BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (K021039) | Depuyacromed | 2002-12-11 |
| PORTADUR P2 (K023395) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-11 |
| HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS (K022928) | Hudson Diagnostic Imaging, LLC | 2002-12-11 |
| MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL (K023928) | Medical Analysis Systems, Inc. | 2002-12-11 |
| T2 SUPRACONDYLAR NAIL SYSTEM (K023267) | Howmedica Osteonics Corp. | 2002-12-11 |
| ACUBEAM, SUPER NOVA, DIO (K022888) | Light Force Therapy, Inc. | 2002-12-11 |
| SNORE-AID MAX (K022284) | Dental Imagineers, LLC | 2002-12-10 |
| CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K023732) | Ciba Vision Corporation | 2002-12-10 |
| BD DIRECTIGEN EZ RSV KIT (K022133) | Becton, Dickinson & CO | 2002-12-10 |
| VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 (K023019) | Vomed Volzer Medizintechnik GmbH & Co. | 2002-12-10 |
| SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X (K020085) | Sintea Biotech, Inc. | 2002-12-10 |
| VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 (K023875) | Ortho-Clinical Diagnostics, Inc. | 2002-12-10 |
| BIOPORTA G (K023391) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-10 |
| THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 (K022377) | Implex Corp. | 2002-12-10 |
| VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 (K023469) | Victus, Inc. | 2002-12-10 |
| SMARTSTEP SYSTEM (K023161) | Andante Medical Device, Ltd. | 2002-12-10 |
| OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) (K023077) | Ocu-Ease Optical Products, Inc. | 2002-12-10 |
| CD HORIZON SPINAL SYSTEM (K014296) | Medtronic Sofamor Danek | 2002-12-10 |
| VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K023876) | Ortho-Clinical Diagnostics, Inc. | 2002-12-10 |
| DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER (K023786) | DePuy Orthopaedics, Inc. | 2002-12-10 |
| MODIFICATION TO VIABAHN ENDOPROSTHESIS (K023811) | W. L. Gore & Associates, Inc. | 2002-12-10 |
| AGILTRAC .035 PERIPHERAL DILATATION CATHETER (K023320) | Guidant Corp. | 2002-12-10 |
| INSTANT-VIEW TCA URINE TEST (K022693) | Alfa Scientific Designs, Inc. | 2002-12-09 |
| AAP CANNULATED SCREWS (K021233) | Aap Implantate AG | 2002-12-09 |
| SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS (K021798) | Smith & Nephew, Inc. | 2002-12-09 |
| IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL (K023304) | Diagnostic Products Corp. | 2002-12-09 |
| ACCESS TOTAL T4 ASSAY (K023369) | Beckman Coulter, Inc. | 2002-12-09 |
| WIENER LAB GOT (AST) UV AA LIQUIDA (K023551) | Wiener Laboratories Saic | 2002-12-09 |
| FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN (K023362) | Fisher Diagnostics | 2002-12-09 |
| AMSINO TRACHEOSTOMY CARE TRAY (K023276) | Amsino International, Inc. | 2002-12-09 |
| WIENER LAB AMILASA 405 AA LIQUIDA (K023549) | Wiener Laboratories Saic | 2002-12-09 |
| ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT (K023098) | Mckinley Infuser | 2002-12-09 |
| WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (K023550) | Wiener Laboratories Saic | 2002-12-09 |
| SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V (K022313) | Power Medical Interventions, Inc. | 2002-12-09 |
| SPECTRUM CERVICAL SPINAL SYSTEM (K022997) | Spinal Innovations, LLC | 2002-12-06 |
| FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM (K021548) | Fotona D.D. | 2002-12-06 |
| AGC SPECIAL ALLOY (K023392) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 |
| ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (K023891) | Tosoh Medics, Inc. | 2002-12-06 |
| MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY (K023846) | Rita Medical Systems | 2002-12-06 |
| VITAL STIM (K023347) | Chattanooga Group | 2002-12-06 |
| BECTON DICKINSON DIABETES SOFTWARE (K023219) | Becton, Dickinson & CO | 2002-12-06 |
| PORTA GEO TI (K023389) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 |
| LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (K023661) | Cliniqa Corporation | 2002-12-06 |
| POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G) (K023577) | Yty Industry (Manjung) Sdn Bhd | 2002-12-06 |
| O.B. TAMPONS (K023789) | Mcneil-Ppc, Inc. | 2002-12-06 |
| ONLINE DAT II COCAINE II (K023281) | Roche Diagnostics Corp. | 2002-12-06 |
| ASCENDENT ACETABULAR SYSTEM (K022985) | Sulzer Orthopedics, Inc. | 2002-12-05 |
| CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 (K023757) | Endocare, Inc. | 2002-12-05 |
| SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP (K023716) | Spsmedical Supply Corp. | 2002-12-05 |
| DISTAL RADIUS FRACTURE REPAIR SYSTEM (K023007) | Hand Innovations, Inc. | 2002-12-05 |
| REPIPHYSIS LIMB SALVAGE SYSTEM (K021489) | Wrightmedicaltechnologyinc | 2002-12-04 |
| M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY (K023871) | Philips Medical Systems | 2002-12-04 |
| NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE (K023016) | Nicore Equipment & Leasing, Inc. | 2002-12-04 |
| TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (K022963) | Transonic Systems, Inc. | 2002-12-04 |
| GIZMO (K023574) | Freedom Designs, Inc. | 2002-12-04 |
| PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE (K023700) | Precision Vascular Systems, Inc. | 2002-12-04 |
| I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE (K023242) | Implant Sciences Corp. | 2002-12-04 |
| INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM (K022048) | Interpore Cross Intl. | 2002-12-04 |
| PEDIATRIC ARTERIAL CANNULA (K023251) | Polystan A/S | 2002-12-04 |
| MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K023810) | Bioplate, Inc. | 2002-12-04 |
| QUICKSET MIMIX BONE VOID FILLER (K023718) | Walter Lorenz Surgical, Inc. | 2002-12-04 |
| STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE (K023108) | Atlantic Products, Inc. | 2002-12-03 |
| ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 (K022176) | Orion Diagnostica, Div. Orion Corp. | 2002-12-03 |
| MODIFICATION TO ENVOY PATIENT MONITOR (K023798) | Mennen Medical , Ltd. | 2002-12-03 |
| IMTEC SENDAX MDI ORTHO6 AND ORTHO8 (K023067) | Imtec Corp. | 2002-12-03 |
| DAUM-LECTRIC MRI DRILLING MACHINE (K021098) | Mri Devices Daum GmbH | 2002-12-03 |
| T-WAVE ALTERMANS (TWA) ALGORITHM OPTION (K023380) | General Electric Medical Systems Information Techn | 2002-12-03 |
| NEWCOR (K020440) | Siemens Medical Systems, Inc. | 2002-12-03 |
| SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM (K022640) | Bacchus Vascular, Inc. | 2002-12-02 |
| MODEL AMI1200 C-ARM (K022911) | Integrity Practice Management, Inc. | 2002-12-02 |
| KSEA SPINOSCOPE (K023187) | Karl Storz Endoscopy | 2002-12-02 |
| J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT (K022518) | Roc Chinese-European Industrial Research Society | 2002-12-02 |
| WRIST IMPLANT (K021859) | Avanta Orthopaedics, Inc. | 2002-12-02 |
| SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER (K023035) | Ivoclar Vivadent, Inc. | 2002-12-02 |