| CLEARFIL PHOTO CORE (K012705) | Kuraray Medical, Inc. | 2001-09-11 |
| CHURCHILL MEDICAL SYSTEMS STOPCOCK (K012157) | Churchill Medical Systems, Inc. | 2001-09-11 |
| POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100 (K012902) | C.R. Bard, Inc. | 2001-09-10 |
| TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER (K011044) | Shen Wei (Usa), Inc. | 2001-09-10 |
| CLEARFIL ST OPAQUER (K012704) | Kuraray Medical, Inc. | 2001-09-10 |
| CLEARFIL CORE NEW BOND (K012703) | Kuraray Medical, Inc. | 2001-09-10 |
| SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC (K012229) | National Custom Ent., Inc. | 2001-09-10 |
| KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (K011841) | Karl Storz Endoscopy | 2001-09-10 |
| PRESSURE ACTIVATED CHECK VALVE (K011888) | Churchill Medical Systems, Inc. | 2001-09-10 |
| AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER (K012136) | Avita Corporation | 2001-09-10 |
| MODIFICATION TO CLEARFIL SE BOND (K012442) | Kuraray Medical, Inc. | 2001-09-10 |
| PALOMAR DERMALUX PULSED LIGHT SYSTEM (K010618) | Palomar | 2001-09-10 |
| CG-2211 SELFCHECK ECG TRANSMITTER (K012223) | Card Guard Scientific Survival , Ltd. | 2001-09-10 |
| AQUANET, MODEL EC 2000 (K000031) | Prime Pacific Health Innovations Corporation | 2001-09-10 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K011806) | Sulzer Intratherapeutics, Inc. | 2001-09-07 |
| CYNOSURE ACCLAIM DERMATOLOGY LASER (K011828) | Cynosure, Inc. | 2001-09-07 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM (K012590) | Cordis Corp. | 2001-09-07 |
| PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 (K010750) | Fisher Diagnostics | 2001-09-07 |
| MPF ACETABULAR CUP (K011836) | Plus Orthopedics | 2001-09-07 |
| MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM (K012836) | GE Medical Systems | 2001-09-07 |
| IMAGER II ANGIOGRAPHIC CATHETER (K011664) | Boston Scientific/Medi-Tech | 2001-09-07 |
| ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 (K012208) | Beckman Coulter, Inc. | 2001-09-07 |
| ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (K011810) | Depuy, Inc. | 2001-09-07 |
| MINI MULTILEAF COLLIMATOR, MODEL KMI (K011816) | Mrc Systems GmbH | 2001-09-07 |
| PANAVIA F (K012441) | Kuraray Medical, Inc. | 2001-09-06 |
| JAS CARBON DIOXIDE LIQUID REAGENT (K012332) | Jas Diagnostics, Inc. | 2001-09-06 |
| JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (K002352) | Jms Co., Ltd. | 2001-09-06 |
| MODIFICATION TO THE I.C.O.S SCREW (K011821) | New Deal, S.A. | 2001-09-06 |
| NEUROTHERM, MODEL JK4 (K011387) | Eurolink, LLC | 2001-09-06 |
| LIVER TAMPONADE BALLOON (K010450) | Cook, Inc. | 2001-09-06 |
| 3.25MM SPLINE TWIST IMPLANT (K012055) | Sulzer Dental, Inc. | 2001-09-06 |
| SYNTHES LCP PROXIMAL HUMERUS PLATES (K011815) | Synthes (Usa) | 2001-09-06 |
| LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (K012656) | Bio-Rad | 2001-09-06 |
| VECTORVISION KNEE (K010612) | Brainlab AG | 2001-09-06 |
| STERILE EMG ELECTRODES (K011818) | Nicolet Biomedical, Inc. | 2001-09-06 |
| NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) (K011128) | Nichols Institute Diagnostics | 2001-09-06 |
| OPTIBOND SOLO PLUS 3 (K011908) | Kerr Dental Materials Center | 2001-09-06 |
| MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM (K012564) | Brainlab AG | 2001-09-06 |
| LC TEMPORARY FILLING (K012360) | Parkell, Inc. | 2001-09-06 |
| BIOREHAB SYSTEM (K011823) | Nicolet Biomedical, Inc. | 2001-09-06 |
| DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE (K011361) | Catheffects, LLC | 2001-09-06 |
| MODIFICATION TO THE TAC' PIN (K011875) | New Deal, S.A. | 2001-09-06 |
| LEAD-LOK REUSABLE TENS/ NMES ELECTRODES (K010431) | Lead-Lok, Inc. | 2001-09-06 |
| MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT (K012584) | Bd | 2001-09-06 |
| GE VISION NUCLEAR MEDICINE WORKSTATION (K012568) | General Electric Co. | 2001-09-06 |
| UROSCOPE, ARTES MEDICAL, USA (K003988) | Artes Medical USA, Inc. | 2001-09-06 |
| VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER (K012050) | Guidant Corp. | 2001-09-06 |
| VERASTEP (K012539) | United States Surgical, A Division of Tyco Healthc | 2001-09-06 |
| AMS SOFT-TISSUE APPROXIMATION SYSTEM (K012342) | American Medical Systems, Inc. | 2001-09-05 |
| CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC (K012573) | Getinge/Castle, Inc. | 2001-09-05 |
| JMS APHERESIS NEEDLE SET ACCORDION TYPE (K002394) | Jms Co., Ltd. | 2001-09-05 |
| MICROCRUISER PLUS INTRODUCER SET (K011790) | Medical Device Technologies, Inc. | 2001-09-05 |
| MHS 5000 (K011981) | Micro Health Systems, Inc. | 2001-09-05 |
| BRITESMILE BARRIER MATERIAL (K010935) | Britesmile, Inc. | 2001-09-05 |
| A-WEAR (K012180) | Bisco, Inc. | 2001-09-05 |
| OMNIDOS (K011763) | Scanditronix Medical AB | 2001-09-05 |
| R120 MODULAR TOTAL HIP SYSTEM (K011774) | Osteoimplant Technology, Inc. | 2001-09-05 |
| DENTORIUM CONVERTIBLE ACRYLIC (K011820) | Nats Corp. | 2001-09-05 |
| MODIFICATION TO PANAVIA 21 (K012438) | Kuraray Medical, Inc. | 2001-09-05 |
| MODIFICATION TO CLEARFIL LINER BOND 2V (K012440) | Kuraray Medical, Inc. | 2001-09-05 |
| EXTRUDE MODIFIED (K012405) | Sybron Dental Specialties, Inc. | 2001-09-04 |
| DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 (K012392) | Pace Medical | 2001-09-04 |
| PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS (K003548) | Padpro, LLC | 2001-09-04 |
| NEXAN SYSTEM, MODEL NX-301 (K010424) | Nexan, Ltd. | 2001-09-04 |
| ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS (K011868) | Debio Tech SA | 2001-09-04 |
| MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET (K012541) | Branan Medical Corp. | 2001-09-04 |
| MODIFICATION TO CLEARFIL PHOTO BOND (K012432) | Kuraray Medical, Inc. | 2001-09-04 |
| ACCU-SPACE ABSORBABLE SEEDING SPACERS (K010621) | Cp Medical | 2001-09-04 |
| ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL (K012799) | Senorx, Inc. | 2001-09-04 |
| DC - CRISTAL (K011674) | Austenal, Inc. | 2001-09-04 |
| TOKUYAMA M-BOND (K011854) | Tokuyama America, Inc. | 2001-09-04 |
| MODIFICATION TO N/T PROTEIN CONTROL SL (K012468) | Dade Behring, Inc. | 2001-09-04 |
| NOVEL PRINT CYAN ALGINATES (K011785) | Manufacturera Dental Continental | 2001-09-04 |
| VENTVIEW, MODEL 8414095 (K012177) | Drager Medizintechnik GmbH | 2001-09-04 |
| MODIFICATION TO ALLOY PRIMER (K012436) | Kuraray Medical, Inc. | 2001-09-04 |
| EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) (K012663) | Sedecal USA, Inc. | 2001-08-31 |
| MBI PD-103 SL; MBI PD-103 SH (K011427) | Mills Biopharmaceuticals, Inc. | 2001-08-31 |
| TENS CARE, MODEL XL-Y3 (K011543) | Tenscare, Ltd. | 2001-08-31 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB (K012292) | The Binding Site, Ltd. | 2001-08-31 |
| INTERCEPT-URETHRAL MICROCOIL (K011781) | Surgi-Vision, Inc. | 2001-08-31 |
| COALESCENT SURGICAL U-CLIP (K012317) | Coalescent Surgical | 2001-08-31 |
| OLYMPUS SUCTION PUMP, MODEL KV-5 (K011725) | Keymed (Medical & Industrial Equipment), Ltd. | 2001-08-31 |
| STRYKER PLATING SYSTEM BASIC FRAGMENT SET (K012162) | Howmedica Osteonics Corp. | 2001-08-31 |
| MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 (K011912) | Axya Medical, Inc. | 2001-08-31 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T (K012296) | The Binding Site, Ltd. | 2001-08-31 |
| AA-1 SYSTEM (K012530) | Neurovision, Inc. | 2001-08-31 |
| STRYKER NAVIGATION SYSTEM-KNEE MODULE (K010204) | Stryker Corp. | 2001-08-31 |
| DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) (K011873) | Dornier | 2001-08-31 |
| MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 (K012476) | Applied Medical Technology, Inc. | 2001-08-31 |
| THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) (K012507) | Implex Corp. | 2001-08-30 |
| OPTIBOND 2 (K012322) | Sybron Dental Specialties, Inc. | 2001-08-30 |
| ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 (K012169) | Intra Luminal Therapeutics, Inc. | 2001-08-30 |
| MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 (K012489) | Appriva Medical, Inc. | 2001-08-30 |
| MICRO TARGETING DRIVE SYSTEM (K011775) | FHC, Inc. | 2001-08-30 |
| MODIFICATION TO:ENDIUS BIPOLAR SHEATH (K012488) | Endius, Inc. | 2001-08-30 |
| EXEL I.V. ADMINISTRATION SET (K010404) | Exelint Intl. Co. | 2001-08-30 |
| LIQUISPX LIQUID LIPID CONTROL (K012855) | Clinical Controls Division | 2001-08-30 |
| SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 (K011729) | Dni Nevada, Inc. | 2001-08-30 |
| SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 (K003804) | Niko Medical Products | 2001-08-30 |
| THE UNI-CLIP STAPLE (K011716) | New Deal, S.A. | 2001-08-30 |