| FIRST SIGN DRUG OF ABUSE SCREENING TEST (K032575) | W.H.P.M., Inc. | 2004-05-19 |
| ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE (K040445) | ACON Laboratories, Inc. | 2004-05-19 |
| S-SCORT...JR QUICKDRAW, MODEL 2400 (K041154) | Sscor | 2004-05-18 |
| VAXCEL PLUS CHRONIC DIALYSIS CATHETER (K040736) | Boston Scientific Corp | 2004-05-18 |
| MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE (K032517) | Medsafe Technologies, LLC | 2004-05-18 |
| ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT (K040013) | Possis Medical, Inc. | 2004-05-18 |
| MONODERM (K040477) | Surgical Specialties Corp | 2004-05-18 |
| GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM (K031357) | Possis Medical, Inc. | 2004-05-18 |
| MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 (K033566) | Rapid Diagnostics, Inc. | 2004-05-17 |
| AMS PERIGEE SYSTEM (K040623) | American Medical Systems, Inc. | 2004-05-17 |
| MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS (K041058) | Misonix, Inc. | 2004-05-17 |
| MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 (K041228) | Mytech Technology Co., Ltd. | 2004-05-17 |
| LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS (K040927) | Cliniqa Corporation | 2004-05-17 |
| AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST (K040464) | Amedica Biotech, Inc. | 2004-05-17 |
| COONRAD/MORREY ELBOW CEMENT RESTRICTOR (K040389) | Zimmer, Inc. | 2004-05-17 |
| SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS (K040870) | Shimadzu Corp. | 2004-05-17 |
| RESTORE WOUND CLEANSER (K040779) | Hollister, Inc. | 2004-05-17 |
| SIEMENS ENHANCED IMAGING SYSTEM (K041166) | Siemens Medical Solutions USA, Inc. | 2004-05-17 |
| NEXT GENERATION SALEM SUMP (K040388) | Kendall | 2004-05-17 |
| LAKE REGION HYDROPHILIC GUIDEWIRE (K040825) | Lake Region Mfg., Inc. | 2004-05-17 |
| CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) (K033869) | Coloplast Corp. | 2004-05-17 |
| RAMP TROPONIN I ASSAY (K033745) | Response Biomedical Corp. | 2004-05-17 |
| ELECSYS TROPONIN T STAT TEST (K040733) | Roche Diagnostics Corp. | 2004-05-17 |
| WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 (K040918) | Wako Chemicals USA, Inc. | 2004-05-17 |
| VUE 100 ULTRASOUND IMAGING SYSTEM (K040652) | Mobilsonic, Inc. | 2004-05-17 |
| STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM (K040390) | Stryker Endoscopy | 2004-05-17 |
| URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM (K041176) | Sofradim Production | 2004-05-17 |
| MULTICORE HB; MULTICORE FLOW (K040795) | Ivoclar Vivadent, Inc. | 2004-05-17 |
| RAMP CK-MB ASSAY (K033747) | Response Biomedical Corp. | 2004-05-17 |
| LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER (K030425) | Walter Lorenz Surgical, Inc. | 2004-05-14 |
| STEP-TIP CHRONIC HEMODIALYSIS CATHETER (K040666) | Arrow International, Inc. | 2004-05-14 |
| MYDON C (K040384) | Wavelight Laser Technologie AG | 2004-05-14 |
| VARELISA HISTONE ANTIBODIES, MODEL 16496 (K040810) | Pharmacia Deutschland GmbH | 2004-05-14 |
| BITESTRIP (K030869) | S.L.P. , Ltd. | 2004-05-14 |
| KMC-950 C-ARM MOBILE SYSTEM (K032761) | United Radiology Systems, Inc. | 2004-05-14 |
| BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS (K040504) | C.R. Bard, Inc. | 2004-05-14 |
| MODIFICATION TO E-SCAN XQ MRI SYSTEM (K041145) | Esaote, S.p.A. | 2004-05-14 |
| NEWTOM 3G QR-DVT 9000 (K041137) | Aperio Services, LLC | 2004-05-14 |
| BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 (K041071) | Becton, Dickinson & CO | 2004-05-14 |
| CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL (K041028) | Crown Delta Corp. | 2004-05-14 |
| DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D (K041027) | Toshibamedical Systems Corporation | 2004-05-14 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML (K040716) | Becton, Dickinson & CO | 2004-05-14 |
| AEQUALIS REVERSED SHOULDER PROSTHESIS (K030941) | Tornier | 2004-05-14 |
| TABLE TILT DEVICE (K033316) | Brainlab AG | 2004-05-14 |
| ENERTRON CPR JACK (K024215) | Enertron Engineering Co. | 2004-05-14 |
| BILIRUBIN ASSAY ON THE OMNI S ANALYZER (K040174) | Roche Diagnostics Corp. | 2004-05-14 |
| MINI GAMMA CAMERA, MODEL MGC-500 (K040587) | Acrorad Co., Ltd. | 2004-05-14 |
| TORSO ARRAY COIL, MODEL 558GE-64 (K041185) | Igc-Medical Advances, Inc. | 2004-05-14 |
| ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) (K040017) | Aesculap, Inc. | 2004-05-14 |
| POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) (K040406) | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 2004-05-14 |
| INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL (K033957) | Draeger Medical Systems, Inc. | 2004-05-14 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K040962) | Medtronic Sofamor Danek | 2004-05-14 |
| INOGEN ONE OXYGEN CONCENTRATOR (K032818) | Inogen, Inc. | 2004-05-13 |
| POLARIS 2004 CAPNOGRAPH (K040011) | Oridion , Ltd. | 2004-05-13 |
| COOL TEMP NATURAL (K041098) | Coltene AG | 2004-05-13 |
| VARELISA SSDNA ANTIBODIES, MODEL 14896 (K040811) | Pharmacia Deutschland GmbH | 2004-05-13 |
| CLEAR-THERM MICRO HME, MODEL 1441 (K032322) | Intersurgical, Inc. | 2004-05-13 |
| SUCTION COAGULATOR (K033003) | Modern Medical Equipment Mfg., Ltd. | 2004-05-13 |
| BIOKNOTLESS RC ANCHOR (K041064) | Depuy Mitek | 2004-05-13 |
| AIR SAFETY HEPA AND NON-HEPA FILTERS (K033008) | Air Safety, Ltd. | 2004-05-13 |
| INOGEN SATELLITE CONSERVER (K033197) | Medical Electronic Devices, Inc. | 2004-05-13 |
| KLS MARTIN HAND PLATING SYSTEM (K040598) | KLS-Martin L.P. | 2004-05-13 |
| MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS (K040990) | Walter Lorenz Surgical, Inc. | 2004-05-13 |
| COLOR LCD MONITOR, MODEL RADIFORCE R12 (K040982) | Eizo Nanao Corporation | 2004-05-13 |
| APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR (K041131) | Apple Medical Corp. | 2004-05-13 |
| LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE (K032965) | Modern Medical Equipment Mfg., Ltd. | 2004-05-13 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN (K040955) | Philips Medical Systems, Inc. | 2004-05-12 |
| ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K033990) | Alveolus, Inc. | 2004-05-12 |
| REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 (K040165) | St Jude Medical | 2004-05-12 |
| AESKULISA CARDIOLIPIN AGM (K040463) | Aesku, Inc. | 2004-05-12 |
| IMPAX OT3000 ORTHOPEDIC WORKSTATION (K040344) | Agfa Corp. | 2004-05-12 |
| SKY BONE EXPANDER SYSTEM (SKY SYSTEM) (K040939) | Disc-O-Tech Medical Technologies, Ltd. | 2004-05-12 |
| HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 (K040381) | Arthrex, Inc. | 2004-05-12 |
| VERICOR (K031327) | Cvp Diagnostics, Inc. | 2004-05-12 |
| RANDOX AMPHETAMINE CLASS ASSAY (K040350) | Randox Laboratories, Ltd. | 2004-05-12 |
| INFINITY GAMMA (K041087) | Draeger Medical Systems, Inc. | 2004-05-12 |
| MODIFICATION TO INFINITY EXPLORER (K040945) | Draeger Medical Systems, Inc. | 2004-05-12 |
| KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT (K041072) | Invacare Corporation | 2004-05-12 |
| 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 (K041056) | Mesure Technology Co., Ltd. | 2004-05-12 |
| TRIFLANGE II ACETABULAR CUP SYSTEM (K040383) | DePuy Orthopaedics, Inc. | 2004-05-12 |
| CHAD THERAPEUTICS SAGE (K033364) | Chad Therapeutics, Inc. | 2004-05-11 |
| EXACTRAC 4.0 AND EXACTRAC X-RAY 6D (K040585) | Brainlab AG | 2004-05-11 |
| LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 (K040424) | Clarus Medical, LLC | 2004-05-11 |
| NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND (K040208) | Tz Medical, Inc. | 2004-05-11 |
| STANDARD IMAGING E.IMRT CALCULATOR (K040688) | Standard Imaging, Inc. | 2004-05-11 |
| DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT (K032016) | Wrp Specialty Products Sdn. Bhd. | 2004-05-11 |
| FOX PLUS PTA CATHETER (K040954) | Abbott Laboratories, Inc. | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (K040451) | Pharmacia Deutschland GmbH | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (K040449) | Pharmacia Deutschland GmbH | 2004-05-11 |
| CRADLE PACS (K033912) | Cradle Technology Corp. | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (K040450) | Pharmacia Deutschland GmbH | 2004-05-11 |
| VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 (K040452) | Pharmacia Deutschland GmbH | 2004-05-11 |
| BIOTOP DJT-A SAFETY SYRINGE (K032747) | Biotop Technology Co., Ltd. | 2004-05-11 |
| Y2K2 ENTERNAL FEEDING MANAGER (K030413) | Moss Medical Products | 2004-05-11 |
| SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS (K040602) | Design Standards Corp. | 2004-05-10 |
| MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS (K041032) | Orbus Medical Technologies | 2004-05-10 |
| QUANTEX FERRITIN (K040879) | Instrumentation Laboratory CO | 2004-05-10 |
| ENDOTINE TRANSBLEPH DEVICE (K040740) | Coapt Systems, Inc. | 2004-05-10 |
| VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES (K041135) | Depuy Mitek, A Johnson & Johnson Company | 2004-05-10 |
| COLLAGEN WOUND DRESSING - ORAL (K040403) | Collagen Matrix, Inc. | 2004-05-10 |