| CBS STRAW (K002595) | Cryo Bio System | 2000-11-17 |
| CN ACQUISITION STATION (K002597) | Cardionow, Inc. | 2000-11-17 |
| GALAXY (K003007) | Sterngold | 2000-11-17 |
| VAGINAL APPLICATOR SHIELDED (K001544) | Mick Radio-Nuclear Instruments, Inc. | 2000-11-17 |
| TISSUE SPECTROSCOPE (K992529) | Vital Medical , Ltd. | 2000-11-17 |
| VIATRONIX VISUALIZATION SYSTEM (VVS) (K002780) | Viatronix, Inc. | 2000-11-17 |
| NUMALINK (K002724) | Numa, Inc. | 2000-11-17 |
| DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA (K003132) | Wrp Specialty Products Sdn. Bhd. | 2000-11-17 |
| MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM (K002840) | The Phantom Laboratory, Inc. | 2000-11-17 |
| CT CORD IQ OPTION 1.0 (K003408) | GE Medical Systems | 2000-11-17 |
| DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A (K002692) | Hmi Industries, Inc. | 2000-11-17 |
| BIOSENSORS CENTRAL VENOUS CATHETER KITS (K002786) | Sunscope Intl., Inc. | 2000-11-17 |
| RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER (K003335) | Hill-Rom Air-Shields | 2000-11-17 |
| INVAC (K002608) | Duncan Hynd Associates, Ltd. | 2000-11-16 |
| HRH-63 HEAD ARRAY COIL (K002774) | Mri Devices Corp. | 2000-11-16 |
| CREATININE PLUS (K003261) | Roche Diagnostics Corp. | 2000-11-16 |
| SSW-STERILE SOLUTION WARMER (K002859) | Kmi Kolster Methods, Inc. | 2000-11-16 |
| BEHRING COAGULATION SYSTEM, MODEL BCS (K002080) | Dade Behring, Inc. | 2000-11-16 |
| ALLEGRO TB, ALLEGRO N (K003434) | Adac Laboratories | 2000-11-16 |
| FRONT-LOAD POLYPROPYLENE SYRINGE (K001663) | Medrad, Inc. | 2000-11-16 |
| HERACERAM (K002993) | J.F. Jelenko & Co., Inc. | 2000-11-16 |
| SILENT NIGHT V (K000253) | Sleep Solutions, Inc. | 2000-11-16 |
| SURESMILE SYSTEM (K002620) | Orametrix, Inc. | 2000-11-16 |
| MODIFICATION TO RAPID DRUG SCREEN 9-PANEL (K002447) | American Bio Medica Corp. | 2000-11-16 |
| ECAT ACCEL PET SCANNER (K002584) | Cti Pet Systems, Inc. | 2000-11-16 |
| MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 (K002572) | Medtronic PS Medical | 2000-11-16 |
| NEWGEN SYSTEM (K002619) | Stryker Instruments | 2000-11-16 |
| MULITPLE MALE LATX CONDOM (K002571) | Pleasure Latex Products Sdn. Bhd. | 2000-11-16 |
| SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (K003399) | Sonosite,Inc. | 2000-11-16 |
| SYNTHES 1.5MM TI BROW LIFT SCREW (K002935) | Synthes (Usa) | 2000-11-16 |
| ADVANCED UROSCIENCE INNERSHEATH (K002573) | Advanced Uroscience, Inc. | 2000-11-16 |
| SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 (K002843) | Sultan Chemists, Inc. | 2000-11-15 |
| SOLOBOND PLUS (K003153) | Voco GmbH | 2000-11-15 |
| LITWIN CRUICATE ANCHOR (K002600) | Instrument Makar, Inc. | 2000-11-15 |
| 35/CD CINECONVERTER (K001841) | Tagarno A/S | 2000-11-15 |
| INTER-OP DURASUL ACETABULAR INSERTS (4MM) (K002575) | Sulzer Orthopedics, Inc. | 2000-11-15 |
| PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 (K001685) | Baxter Healthcare Corp | 2000-11-15 |
| WELCH ALLYN SPOT CHECK DEVICE (K002530) | Welch Allyn, Inc. | 2000-11-14 |
| VBMAX (K000654) | A-M Systems, Inc. | 2000-11-14 |
| MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 (K003308) | Microlife Corp. | 2000-11-14 |
| NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K002677) | Nuvasive, Inc. | 2000-11-13 |
| TISSUELINK MONOPOLAR FLOATING BALL' (K002680) | Tissuelink Medical, Inc. | 2000-11-13 |
| ROVERS SPATULA (K002520) | Rovers Medical Devices B.V. | 2000-11-13 |
| AMT SPINAL SYSTEM (K002059) | Micron Precision Engineering, Inc. | 2000-11-13 |
| MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 (K002023) | Medmira Laboratories, Inc. | 2000-11-13 |
| SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS (K001993) | Abbott Laboratories | 2000-11-13 |
| HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE (K002552) | Howmedica Osteonics Corp. | 2000-11-13 |
| PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI (K001177) | Enteric Products, Inc. | 2000-11-13 |
| SPARTAN MTS (K002521) | Spartan Marketing Group | 2000-11-13 |
| SURGICAL SYSTEM WITH CRYOGUIDE (K002615) | Endocare, Inc. | 2000-11-13 |
| ALLON 2001 MODIFIED (K003349) | Mtre Advanced Technology , Ltd. | 2000-11-13 |
| NEXTSTITCH CARDIOVASCULAR VALVE SUTURE (K001440) | Genzyme Surgical Product (Genzyme Biosurgery) | 2000-11-13 |
| PRECIMED TRAUMA SYSTEM (K002486) | Patrick Berdoz | 2000-11-09 |
| SAMSUNG 10DR IMPLANT SYSTEM (K002062) | Samsung Sds Co., Ltd. | 2000-11-09 |
| KENDRO HERACELL CO2 INCUBATOR (K002805) | Kendro Laboratory Products, L.P. | 2000-11-09 |
| REPLACE TPS COATED IMPLANTS (K002475) | Nobel Biocare Uas, Inc. | 2000-11-09 |
| FETALGARD LITE (K002503) | Analogic Corp. | 2000-11-09 |
| 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS (K002357) | Pie Medical | 2000-11-09 |
| ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 (K002687) | Zynergy Cardiovascular, Inc. | 2000-11-09 |
| FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO (K002720) | Tillotson Healthcare Corp. | 2000-11-09 |
| CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) (K002693) | Cbs Intl. B.V. | 2000-11-09 |
| SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM (K003179) | Siemens Medical Solutions USA, Inc. | 2000-11-09 |
| LUMBOPERITONEAL SHUNT SYSTEM (K002476) | Phoenix Biomedical Corp. | 2000-11-09 |
| CERAM-PRIME (K002502) | S & C Polymer GmbH | 2000-11-08 |
| QWH-149 WRIST ARRAY COIL (K003331) | Mri Devices Corp. | 2000-11-08 |
| PCCR DIGITAL IMAGING DEVICE (K003256) | Orex Computed Radiography, Ltd. | 2000-11-08 |
| STELLAR (K002463) | Skytron, Div. the Kmw Group, Inc. | 2000-11-08 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K003167) | Masimo Corp. | 2000-11-08 |
| WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES (K002473) | Nihon Kohden America, Inc. | 2000-11-08 |
| PERSONAL ECG TRANSMITTER, MODEL CG-6550 (K003220) | Card Guard Scientific Survival , Ltd. | 2000-11-08 |
| PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING (K002707) | Precision Vascular Systems, Inc. | 2000-11-08 |
| OBC-149 BREAST ARRAY COIL (K003340) | Mri Devices Corp. | 2000-11-08 |
| PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH (K002459) | Agilent Technologies, Inc. | 2000-11-08 |
| CARESIDE CHOLINESTERASE (K002792) | Careside, Inc. | 2000-11-08 |
| BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE (K002499) | Brentwood Medical Technology Corp. | 2000-11-08 |
| ETEST LINEZOLID (K002139) | Ab Biodisk | 2000-11-08 |
| FREEDOM AUTOMATIC FILM PROCESSOR (K002640) | J. Morita USA, Inc. | 2000-11-08 |
| SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K003315) | Mallinckrodt, Inc. | 2000-11-08 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K003244) | Masimo Corp. | 2000-11-08 |
| OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (K002966) | Ocu-Ease Optical Products, Inc. | 2000-11-08 |
| IRIS RETRACTING PHACOEMULSIFICATION SLEEVE (K002812) | Michael Reynard, M.D. | 2000-11-08 |
| ETHIBOND EXCEL VALVE LOOP SUTURE (K003070) | ETHICON, Inc. | 2000-11-07 |
| MULTIPLE-VINYL EXAM GLOVE, POWDERED (K003133) | Excellence Ent. Co., Ltd. | 2000-11-07 |
| R & D 3K RETIC (K003208) | R&D Systems, Inc. | 2000-11-07 |
| IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ (K003181) | Implex Corp. | 2000-11-07 |
| KM-10 TENS ELECTRODE (K000870) | Katecho, Inc. | 2000-11-07 |
| DUPLOGRIP (K003193) | Baxter Healthcare Corp | 2000-11-07 |
| CNS-9300 SERIES CENTRAL STATION (K001433) | Nihon Kohden America, Inc. | 2000-11-07 |
| BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (K003204) | Intracel Corp. | 2000-11-07 |
| MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (K003087) | Sporicidin Intl. | 2000-11-07 |
| VIPON TAMPON (K992493) | Another Way Products, LLC | 2000-11-06 |
| WILLI GELLER CREATION AND LF PORCELAIN (K002904) | Jensen Industries, Inc. | 2000-11-06 |
| FRIENDLY LIGHT ER:YAG PULSED LASER (K000023) | Innotech USA, Inc. | 2000-11-06 |
| BIOMET SCK KNEE SYSTEM (K003296) | Biomet, Inc. | 2000-11-06 |
| MODEL K7 EVALUATION DEVICE (K003287) | Myotronics-Noromed, Inc. | 2000-11-06 |
| PE.R.I. II KNEE FRACTURE SYSTEM (K003235) | DePuy Orthopaedics, Inc. | 2000-11-06 |
| VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 (K002990) | Vascular Technology Incorporated | 2000-11-06 |
| MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K003222) | Computer Motion, Inc. | 2000-11-03 |
| ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM (K001044) | Acme Spine, LLC | 2000-11-03 |
| BIOMET LATERAL TROCH PLATE (K003294) | Biomet, Inc. | 2000-11-03 |