| SMART 2940 D ER: YAG LASER (K031317) | Cynosure, Inc. | 2003-05-22 |
| MODIFICATION TO FOSSA URETERAL STONE SWEEPER (K031292) | Fossa Medical, Inc. | 2003-05-22 |
| EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, (K031518) | Medtronic Vascular | 2003-05-22 |
| SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM (K030623) | Smith & Nephew, Inc. | 2003-05-22 |
| DRI COTININE EIA ASSAY (K030649) | Microgenics Corp. | 2003-05-22 |
| THERMACOOL TC SYSTEM (K031046) | Thermage, Inc. | 2003-05-22 |
| DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 (K031379) | Smith & Nephew, Inc. | 2003-05-22 |
| EASYCUP (K023823) | Zer Hitech | 2003-05-22 |
| HLS UNI EVOLUTION PROSTHESIS (K022211) | Tornier | 2003-05-22 |
| AVITA BF1 (VITALIO) BODY FAT ANALYZER (K020738) | Avita Corporation | 2003-05-22 |
| TEXAS T - PLATE (K031334) | Biomet, Inc. | 2003-05-22 |
| DIGNITY OPHTHALMIC SURGICAL SYSTEM (K031404) | Phacor Inc., A Santen Company | 2003-05-22 |
| MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM (K031388) | Hypoguard USA, Inc. | 2003-05-22 |
| CEMEX SYSTEM FAST (K031430) | Exactech, Inc. | 2003-05-22 |
| CODMAN ISOCOOL BIPOLAR FORCEPS (K023566) | Codman & Shurtleff, Inc. | 2003-05-22 |
| AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 (K031469) | Toshiba America Medical Systems, In.C | 2003-05-22 |
| MODEL 5071 MYOCARDIAL PACING LEAD (K031274) | Medtronic Vascular | 2003-05-22 |
| COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING (K030845) | Roche Diagnostics Corp. | 2003-05-22 |
| DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE (K030812) | Datex-Ohmeda | 2003-05-21 |
| VARISEED 7.1 (K030534) | Varian Medical Systems | 2003-05-21 |
| ACMI VISTA CTR BIPOLAR LOOP ELECTRODE (K031001) | Acmi Corporation | 2003-05-21 |
| RADIOMED SOFT TISSUE MARKER (K031206) | Radiomed Corp. | 2003-05-21 |
| MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY (K030558) | Proxima Therapeutics, Inc. | 2003-05-21 |
| ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II (K030576) | The Anspach Effort, Inc. | 2003-05-21 |
| TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828) | Beckman Coulter, Inc. | 2003-05-21 |
| RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM (K030544) | Sigma Vision, Inc. | 2003-05-21 |
| PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE (K030617) | Boston Scientific Scimed, Inc. | 2003-05-21 |
| MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS (K030589) | NuMED, Inc. | 2003-05-21 |
| COOL TOUCH 3 (K031184) | New Star Lasers, Inc. | 2003-05-21 |
| CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G (K031447) | Canon, Inc. | 2003-05-21 |
| FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE (K031020) | Pt. Mandiri Inti Buana | 2003-05-21 |
| EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS (K031081) | Gyrus Medical, Inc. | 2003-05-21 |
| SPIN DOWN RAPIDFLAP (K031034) | Walter Lorenz Surgical, Inc. | 2003-05-21 |
| EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE (K031079) | Gyrus Medical, Inc. | 2003-05-21 |
| MYTHOS 500 (K030805) | Msq (M2) , Ltd. | 2003-05-21 |
| EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK (K031082) | Gyrus Medical, Inc. | 2003-05-21 |
| AMERITEK SURE-POINT TRACKER SYSTEM (K030518) | Amertek Medical, Inc. | 2003-05-20 |
| SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 (K031053) | Selectivemed Components, Inc. | 2003-05-20 |
| IS-1 HEMOSTASIS VALVE, MODEL 6799 (K031398) | Guidant Corp. | 2003-05-20 |
| BODY CLOCK TENS N' TONE (K022849) | Body Clock Health Care, Ltd. | 2003-05-20 |
| FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES (K030497) | Fresenius Medical Care | 2003-05-20 |
| C.T.M. MOBILITY SCOOTER, MODEL HS-120 (K031272) | C.T.M. Homecare Product, Inc. | 2003-05-20 |
| OSSATURA BCP BONE VOID FILLER (K030131) | Isotis NV | 2003-05-20 |
| ROSS EMBRACE ENTERAL PUMP (K031407) | Ross Product Div. Abbott Laboratories | 2003-05-20 |
| HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 (K022998) | Home Care Technology Co., Ltd. | 2003-05-20 |
| COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 (K030355) | Comfort Orthopedic Co., Ltd. | 2003-05-20 |
| LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS (K030527) | Lumenis | 2003-05-20 |
| T.E.A.R. TECH3 MODEL #44TT03 (K030507) | Vision Quest Industries, Inc. | 2003-05-20 |
| COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 (K030356) | Comfort Orthopedic Co., Ltd. | 2003-05-20 |
| DISPOSABLE POWDERED VINYL EXAM GLOVES (K031134) | Elite International, Inc. | 2003-05-20 |
| EVERSTICK POST (K030820) | Stick Tech , Ltd. | 2003-05-20 |
| CALLOS (K030554) | Skeletal Kinetics, LLC | 2003-05-20 |
| 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 (K030502) | Medcomp | 2003-05-20 |
| SR-130 (K030494) | Source-Ray, Inc. | 2003-05-20 |
| DEPILASE TRIO LASE LASER SYSTEM (K030508) | Depilase Group , Ltd. | 2003-05-20 |
| HEMOSIL FACTOR X DEFICIENT PLASMA (K031122) | Instrumentation Laboratory CO | 2003-05-19 |
| DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 (K030952) | Dolphin Medical, Inc. | 2003-05-19 |
| MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD (K031285) | Megadyne Medical Products, Inc. | 2003-05-19 |
| ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH (K030631) | Prosurg, Inc. | 2003-05-19 |
| INTERPORE CROSS CEMENT RESTRICTOR (K023908) | Interpore Cross Intl. | 2003-05-16 |
| EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS (K031078) | Gyrus Medical, Inc. | 2003-05-16 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML (K030986) | Becton, Dickinson & CO | 2003-05-16 |
| MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218) | Tornier | 2003-05-16 |
| EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS (K031080) | Gyrus Medical, Inc. | 2003-05-16 |
| CD HORIZON SPINAL SYSTEM (K030932) | Medtronic Sofamor Danek, Inc. | 2003-05-16 |
| MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210) | Metronic, Inc. | 2003-05-16 |
| PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (K023857) | Bio-Rad | 2003-05-16 |
| PEAK MOTUS (K030714) | Peak Performance Technologies, Inc. | 2003-05-16 |
| PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 (K030925) | Ethicon Endo-Surgery, Inc. | 2003-05-15 |
| TPSA FLEX REAGENT CARTRIDGE (K031343) | Dade Behring, Inc. | 2003-05-15 |
| SURGISIS NERVE CUFF (K031069) | Cook Biotech, Inc. | 2003-05-15 |
| MODIFICATION TO HORIZON SPINAL SYSTEM (K030840) | Medtronic Sofamor Danek, Inc. | 2003-05-15 |
| BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM (K031295) | C.R. Bard, Inc. | 2003-05-15 |
| TENO FIX (K023594) | Ortheon Medical, LLC | 2003-05-15 |
| ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K030947) | Alveolus, Inc. | 2003-05-15 |
| BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH (K031332) | C.R. Bard, Inc. | 2003-05-15 |
| COLLAGEN TOPICAL WOUND DRESSING (K030921) | Collagen Matrix, Inc. | 2003-05-15 |
| MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM (K022506) | Widemed, Ltd. | 2003-05-15 |
| DEPILASE TWIN YAG LASER SYSTEM (K030510) | Depilase Group , Ltd. | 2003-05-14 |
| MATRIX STRETCH RESISTANT DETACHABLE COIL (K031168) | Boston Scientific, Target | 2003-05-14 |
| IBC FLOPUMP WITH GBS COATING (K031300) | Gish Biomedical, Inc. | 2003-05-14 |
| AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER (K030748) | Clearlab Pte , Ltd. | 2003-05-14 |
| COZART EIA COTININE URINE KIT (K021944) | Cozart Bioscience , Ltd. | 2003-05-14 |
| GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM (K030512) | Guidant Corp. | 2003-05-14 |
| L600 HAIR REMOVAL (K030480) | A&M Technology | 2003-05-14 |
| HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG (K030549) | Guidcorp | 2003-05-14 |
| CODMAN BACTISEAL BARIUM STRIPED CATHETERS (K031123) | Codman & Shurtleff, Inc. | 2003-05-14 |
| GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 (K030917) | Collins Medical, Inc. | 2003-05-14 |
| OLYMPIC CFM 6000 (K031149) | Olympic Medical Corp. | 2003-05-14 |
| JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (K031277) | Jomed, Inc. | 2003-05-14 |
| CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 (K031086) | Integra Neurosciences | 2003-05-14 |
| COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR (K023733) | Ingenjorsfirman Bjorn Bergdahl AB | 2003-05-14 |
| CAPIOX CARDIOTOMY RESERVOIR (K030505) | Terumo Cardiovascular Systems Corp. | 2003-05-14 |
| SYREX PRE-FILLED SYRINGE (K023740) | Excelsior Medical Corp. | 2003-05-13 |
| MAHURKAR OPLUS CATHETER, MODEL 13.5 FR (K030209) | The Kendall Company | 2003-05-13 |
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 (K031333) | Philips Medical Systems North America, Inc. | 2003-05-13 |
| DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 (K022834) | Ge Medical Systems Information Technologies | 2003-05-13 |
| MODIFICATION TO EASYS TRANSVERSE CONNECTION (K031290) | Scient'X USA, Inc. | 2003-05-13 |
| EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE (K031037) | Medtronic Perfusion Systems | 2003-05-13 |
| ADVANTAGE WORKSTATION PASTING 1.1 (K031396) | GE Medical Systems | 2003-05-13 |