| MODIFICATION TO EN-BLOC BIOPSY SYSTEM (K033427) | Neothermia Corp. | 2003-11-10 |
| BLOOD PRESSURE MONITOR, MODEL M100 (K032308) | Meditek Technology, Inc. | 2003-11-10 |
| POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 (K032607) | Linvatec Corp. | 2003-11-10 |
| PROFILE -ER (K033334) | Medtox Diagnostics, Inc. | 2003-11-10 |
| STAR (LUNAR SERIES) MONITORING SYSTEM (K032867) | Larsen & Toubro Limited | 2003-11-10 |
| SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION (K032475) | Siemens Medical Solutions USA, Inc. | 2003-11-10 |
| SUMMIT STAIRWAY LIFT (K032880) | Summit Lifts, Inc. | 2003-11-10 |
| WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR (K033032) | Wu'S Tech Co., Ltd. | 2003-11-10 |
| RELIANT LASER SYSTEM (K031795) | Reliant Technologies, Inc. | 2003-11-10 |
| MEDICHEART, MODEL RELEASE 1 (K032823) | Medicsight | 2003-11-10 |
| DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (K032697) | Dade Behring, Inc. | 2003-11-07 |
| PANAVIA F 2.0 (K032455) | Kuraray Medical, Inc. | 2003-11-07 |
| ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA (K032647) | Wrp Asia Pacific Sdn. Bhd. | 2003-11-07 |
| DGH 55 HANDHELD PACHYMETER (PACHMATE) (K033385) | Dgh Technology, Inc. | 2003-11-07 |
| CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE (K033061) | Diamond Diagnostics, Inc. | 2003-11-07 |
| PROCLEAR COMPATIBLES MULTIFOCAL (K032873) | CooperVision, Inc. | 2003-11-07 |
| 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 (K033430) | Implant Innovations, Inc. | 2003-11-07 |
| DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE (K032473) | Stryker Instruments | 2003-11-07 |
| DYNALOK CLASSIC SPINAL SYSTEM (K033271) | Medtronic Sofamor Danek | 2003-11-06 |
| AMBIT INTERMITTENT AMBULATORY INFUSION PUMP (K033425) | Sorenson Medical, Inc. | 2003-11-06 |
| VITERION 100 TELEHEALTH MONITOR (K030419) | Viterion Telehealthcare, LLC | 2003-11-06 |
| LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K033374) | Siemens AG Medical Solutions | 2003-11-06 |
| LIFEPAK 12, 20, 500, CR PLUS (K033275) | Medtronic Physio-Control Corp. | 2003-11-06 |
| APEXPRO FH TELEMETRY SYSTEM (K033365) | Ge Medical Systems Information Technologies | 2003-11-06 |
| KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K030359) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2003-11-06 |
| BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K033245) | C.R. Bard, Inc. | 2003-11-06 |
| AMBIT CONTINUOUS AMBULATORY INFUSION PUMP (K033325) | Sorenson Medical, Inc. | 2003-11-06 |
| MULTILINK (K032470) | Ivoclar Vivadent, Inc. | 2003-11-05 |
| INVISIJECT RESUSABLE AUTO-INJECTOR (K032425) | Biogen | 2003-11-05 |
| VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS (K033034) | Zimmer, Inc. | 2003-11-05 |
| TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 (K033367) | Sonosite,Inc. | 2003-11-05 |
| VIATRONIX V3D VASCULAR, REVISION 1.0 (K033361) | Viatronix, Inc. | 2003-11-05 |
| HOFFMANN II PELVIC CLAMP (K033145) | Howmedica Osteonics Corp. | 2003-11-05 |
| VITOSS-FILLED CARTRIDGE (K032130) | Orthovita, Inc. | 2003-11-05 |
| ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (K032439) | Zoll Medical Corp | 2003-11-05 |
| MEDIC COLON MODEL, RELEASE 1 (K033102) | Medicsight | 2003-11-05 |
| SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM (K033071) | Synthes (Usa) | 2003-11-05 |
| PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE (K031073) | Novabone Products, LLC | 2003-11-05 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS (K033300) | Ortho-Clinical Diagnostics, Inc. | 2003-11-05 |
| MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM (K033247) | Medrad, Inc. | 2003-11-05 |
| HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER (K033224) | Hologic, Inc. | 2003-11-05 |
| SELECTIVA SB GUIDEWIRE (K033321) | Neometrics, Inc. | 2003-11-05 |
| LACTOSORB TIBIAL L-15 SCREW AND WASHER (K033233) | Biomet, Inc. | 2003-11-05 |
| SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE (K033416) | Medtronic Perfusion Systems | 2003-11-05 |
| WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS (K033112) | Hand Biomechanics Lab, Inc. | 2003-11-05 |
| SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES (K033158) | Synthes (Usa) | 2003-11-05 |
| ECHOCONNEX COMMUNICATOR (K033093) | Connexmd | 2003-11-05 |
| GIARDIA II (K033274) | Techlab, Inc. | 2003-11-04 |
| BISCEM GI (K032597) | Bisco, Inc. | 2003-11-04 |
| HYDRAGEL CSF ISOFOCUSING KITS (K033277) | Morax | 2003-11-04 |
| THERATEARS CONTACT LENS COMFORT DROPS (K032481) | Advanced Vision Research, Inc. | 2003-11-04 |
| COLIBRI DISPOSABLE VITRECTOMY CUTTER (K033390) | Microworld Medical Instruments, Inc. | 2003-11-04 |
| VITEK 2 GRAM NEGATIVE GATIFLOXACIN (K032788) | bioMerieux, Inc. | 2003-11-04 |
| SPI EASY DENTAL IMPLANT PROTECTIVE CAP (K033346) | Thommen Medical AG | 2003-11-03 |
| ATAC HEMOGLOBIN A1C REAGENT KIT (K031042) | Clinical Data, Inc. | 2003-11-03 |
| EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE (K031946) | Edwards Lifesciences, LLC | 2003-11-03 |
| GUTTAFLOW (K032662) | Coltene/Whaledent GmbH & Co. KG | 2003-11-03 |
| BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) (K032764) | Lin-Zhi International, Inc. | 2003-11-03 |
| CRYOCHECK WEAK LUPUS POSITIVE CONTROL (K032804) | Precision Biologic | 2003-11-03 |
| OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM (K031708) | Osteomed LP | 2003-11-03 |
| PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR (K033130) | Osypka Medical, Inc. | 2003-10-31 |
| SPINERX-LDM (K031862) | Spinerx Technology | 2003-10-31 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS (K032993) | Ortho-Clinical Diagnostics, Inc. | 2003-10-31 |
| IONOFIL COLOR AC (K033068) | Voco GmbH | 2003-10-31 |
| BONE CEMENT RADIO-OPACIFIER (K032388) | Cardinalhealth | 2003-10-31 |
| MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES (K033264) | Medtronic Perfusion Systems | 2003-10-31 |
| MERCATOR HEALTHCARE MALE LATEX CONDOM (K031369) | Mercator Healthcare , Ltd. | 2003-10-31 |
| DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 (K032564) | Dade Behring, Inc. | 2003-10-31 |
| ZOLL M SERIES NIBP OPTION (K032363) | Zoll Medical Corp | 2003-10-31 |
| DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS (K013452) | Danmar Products, Inc. | 2003-10-31 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS (K033127) | Ortho-Clinical Diagnostics | 2003-10-31 |
| MODIFICATION TO GLOBALCARDIO (K033037) | Cardiocomm Solutions, Inc. | 2003-10-31 |
| GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET (K032426) | Cook, Inc. | 2003-10-31 |
| DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 (K032573) | Dade Behring, Inc. | 2003-10-31 |
| PHERON PTA CATHETER (K033217) | Biotronik, Inc. | 2003-10-31 |
| FUKUDA DENSHI MODEL FF SONIC UF-750XT (K033209) | Fukuda Denshi USA, Inc. | 2003-10-31 |
| PLUS PIVOT LINK UNIVERSAL SYSTEM (K032398) | Spine Vision, Inc. | 2003-10-31 |
| VITEK 2 GRAM POSITIVE LINEZOLID (K032766) | bioMerieux, Inc. | 2003-10-31 |
| K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT (K033263) | Track Corporation | 2003-10-31 |
| NIPRO DISPOSABLE SYRINGES (K030683) | Nipro Medical Corp. | 2003-10-31 |
| CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD (K031963) | Wrightmedicaltechnologyinc | 2003-10-31 |
| SUN-RAIN ULTRASONIC THERAPY, SU-100 (K024013) | Sun-Rain System Corp. | 2003-10-31 |
| KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K030358) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2003-10-31 |
| AUDICOR UPGRADE SYSTEM (K032145) | Inovise Medical, Inc. | 2003-10-31 |
| JABES ELECTRONIC STETHOSCOPE (K031446) | Gs Technology Co., Ltd. | 2003-10-31 |
| HEDROCEL VERTEBRAL BODY REPLACEMENT (K032527) | Implex Corp. | 2003-10-31 |
| VITEK GRAM NEGATIVE GATIFLOXACIN (K032711) | bioMerieux, Inc. | 2003-10-31 |
| VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN (K032738) | bioMerieux, Inc. | 2003-10-31 |
| INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM (K033305) | Draeger Medical Systems, Inc. | 2003-10-31 |
| LIFESTENT SDS BILIARY ENDOPROSTHESIS (K033212) | Orbus Medical Technologies | 2003-10-30 |
| RATIONAL IMAGING PACS (K031473) | Intuitive Imaging Informatics, LLC | 2003-10-30 |
| A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS (K032499) | A&D Engineering, Inc. | 2003-10-30 |
| MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS (K032731) | Turbo Wheelchair Co., Inc. | 2003-10-30 |
| FERTELL FEMALE FERTILITY TEST (K032002) | Genosis, Inc. | 2003-10-30 |
| MECHANICAL WHEEHCHAIR (K033141) | Pacific Medical Suppliers, Inc. | 2003-10-30 |
| ARTHROCARE ENT PLASMA WANDS (K033257) | Arthrocare Corp. | 2003-10-30 |
| PROFUSION BONE VOID FILLER KIT (K031838) | Biogeneration | 2003-10-30 |
| ENDOHELIX ENDARTERECTOMY DEVICE (K032105) | Endarx, Inc. | 2003-10-30 |
| INION CPS BABY 1.5 BIOABSORBABLE SYSTEM (K033194) | Inion , Ltd. | 2003-10-30 |
| DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A (K032798) | Dade Behring, Inc. | 2003-10-30 |