| A-22 HEMODIALYZER (K992563) | Althin Medical AB | 2000-01-18 |
| RHIGENE ANA ELISA TEST SYSTEM (K994071) | Rhigene, Inc. | 2000-01-18 |
| CYNOSURE PHOTOGENICA SPIR (K994437) | Cynosure, Inc. | 2000-01-18 |
| PHASED ARRAY KNEE AND FOOT COIL (K994040) | Usa Instruments, Inc. | 2000-01-18 |
| STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX (K993239) | Stryker Corp. | 2000-01-18 |
| LITESABER 2000 (K993942) | Laser Dental Innovations | 2000-01-18 |
| SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES (K994081) | Safeskin Corp. | 2000-01-18 |
| V.A.C. PLUS (K992448) | Kinetic Concepts, Inc. | 2000-01-18 |
| TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES (K993847) | Longbest (Xiamen) Balls Co., Ltd. | 2000-01-18 |
| RENAMEL PACK (K993659) | Cosmedent, Inc. | 2000-01-18 |
| ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 (K994330) | Aspect Medical Systems, Inc. | 2000-01-18 |
| HARDYDISK IMIPENEM, 10MCG (K994132) | Hardy Diagnostics | 2000-01-18 |
| CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER (K993720) | Cordis Corp. | 2000-01-18 |
| THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM (K992727) | Mds | 2000-01-18 |
| LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR (K990445) | Lpg USA, Inc. | 2000-01-18 |
| SHARPVIEW IMAGE ENHANCEMENT SYSTEM (K993802) | Context Vision AB | 2000-01-18 |
| OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON (K993574) | Toshiba America Mri, Inc. | 2000-01-18 |
| ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 (K993920) | Diagnostic Chemicals , Ltd. | 2000-01-18 |
| OSOM ULTRA STREP A TEST, MODEL 147 (K992658) | Wyntek Diagnostics, Inc. | 2000-01-18 |
| MULTIFUNCTION KEITO K5 (K984083) | Bumedco Intl., Inc. | 2000-01-18 |
| VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K991916) | Virginia Water Systems, Inc. | 2000-01-14 |
| XE CHECK (K994388) | Streck Laboratories, Inc. | 2000-01-14 |
| HARDY DISK AMPICILLIN/SULBACTAM (K994067) | Hardy Diagnostics | 2000-01-14 |
| ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM (K992851) | Roche Diagnostics Corp. | 2000-01-14 |
| MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN (K993679) | Dade Microscan, Inc. | 2000-01-14 |
| WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (K993927) | Wako Chemicals USA, Inc. | 2000-01-14 |
| RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST (K993519) | Cardiovascular Diagnostics, Inc. | 2000-01-14 |
| MICROSTREP PLUS PANEL, VANCOMYCIN (K983953) | Dade Microscan, Inc. | 2000-01-14 |
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM (K992684) | Abbott Diabetes Care, Inc. | 2000-01-14 |
| PHARMASEED, MODEL BT-103-1 (K992007) | Syncor Pharmaceuticals, Inc. | 2000-01-14 |
| WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993924) | Wako Chemicals USA, Inc. | 2000-01-14 |
| HEMOSITE TEST SYSTEM (K994073) | Gds Technology, LLC | 2000-01-14 |
| ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 (K994439) | Beckman Coulter, Inc. | 2000-01-14 |
| MAGNETOM OPEN VIVA WITH PERMANENT MAGNET (K994316) | Siemens Medical Corp. | 2000-01-14 |
| ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 (K992749) | Spacelabs Medical, Inc. | 2000-01-14 |
| IBC FLOGUARD, MODEL 6050 (K992785) | International Biophysics Corp. | 2000-01-14 |
| HARDYDISK AZTREONAM, 30MCG (K994063) | Hardy Diagnostics | 2000-01-14 |
| FORTOSS-CEMA (K993238) | Biocomposites, Ltd. | 2000-01-14 |
| INFRARED EAR THERMOMETER, MODEL KI-8120 (K984551) | K-Jump Health Co., Ltd. | 2000-01-14 |
| ACCESS OSTASE QC (K994277) | Beckman Coulter, Inc. | 2000-01-14 |
| ITP, MODEL 1.0 (K992434) | Nucletron Corp. | 2000-01-13 |
| VENAFLOW SYSTEM, MODEL 30A (K992454) | Aircast, Inc. | 2000-01-13 |
| PE 501 PC-ECG MONITOR (K992584) | Nhe Corp. | 2000-01-13 |
| PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX (K993531) | Datascope Corp. | 2000-01-13 |
| ATW MARKER WIRE STEERABLE GUIDEWIRE (K994358) | Cordis Corp. | 2000-01-13 |
| MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS) (K991862) | Micomed GmbH | 2000-01-13 |
| MODIFICATION TO BONE ANCHOR AND KIT (BAK) (K994313) | Axya Medical, Inc. | 2000-01-13 |
| AESCULAP VASCULAR INSTRUMENTS (K992053) | Aesculap, Inc. | 2000-01-13 |
| MANUAL WHEELCHAIR (K994185) | Major Mobility Products, Inc. | 2000-01-13 |
| TRX-CG POWER TILT AND RECLINE SYSTEM (K994241) | Motion Concepts | 2000-01-13 |
| AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM (K994072) | Amylior, Inc. | 2000-01-13 |
| SOCON SPINAL SYSTEM (K993551) | Aesculap, Inc. | 2000-01-13 |
| NIPRO LUER ADAPTOR (K992729) | Nipro Medical Corp. | 2000-01-13 |
| AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 (K994208) | Medtronic Perfusion Systems | 2000-01-13 |
| MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) (K993377) | Polymer Technology Systems, Inc. | 2000-01-13 |
| PORTABLE LIGHT CURING UNIT (K994048) | Gregory S. Jacob, D.D.S. | 2000-01-13 |
| SIGMA MANUAL WHEELCHAIR (K993963) | Sigma Distribution & Supply, Inc. | 2000-01-13 |
| AVIVA SYSTEM, MODEL SL1010 (K993550) | American Telecare, Inc. | 2000-01-13 |
| AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS. (K994107) | Amylior, Inc. | 2000-01-13 |
| BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B (K990987) | Arthrex, Inc. | 2000-01-13 |
| A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM (K992779) | Medi-Man Rehabilitation Products, Inc. | 2000-01-13 |
| ACUMED SUTURE ANCHOR (K993657) | Acu Med, Inc. | 2000-01-13 |
| ADMIRA (K994056) | Voco GmbH | 2000-01-12 |
| GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE (K993793) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-01-12 |
| INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS] (K993567) | Innovative Gloves Co;, Ltd. | 2000-01-12 |
| HANNAH WIRELESS VITAL SIGNS MONITOR (K991087) | Ilife Systems, Inc. | 2000-01-12 |
| SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K993859) | Shanghai Glovmax Enterprise Co.,Ltd | 2000-01-12 |
| SEGMENTED VAGINAL APPLICATOR (K993472) | Mick Radio-Nuclear Instruments, Inc. | 2000-01-12 |
| SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K993880) | Shanghai Glovmax Enterprise Co.,Ltd | 2000-01-12 |
| CONVERTORS SURGICAL DRAPES (K993795) | Allegiance Healthcare Corp. | 2000-01-12 |
| BIORCI SCREW (K992396) | Smith & Nephew Endoscopy, Inc. | 2000-01-12 |
| SIEMEMNS INFINITY ETC02 POD (K992116) | Siemens Medical Solutions USA, Inc. | 2000-01-12 |
| LEMAITRE BILIARY CATHETER (K992941) | Vascutech, Inc. | 2000-01-12 |
| ENA PROFILE ELISA TEST SYSTEM (K993839) | Trinity Biotech USA | 2000-01-12 |
| HOT SHOT FLUID WARMER IV FLUIDS (K992258) | Infra-Med Technologies, Inc. | 2000-01-12 |
| AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE (K992719) | Amsino Intl., Inc. | 2000-01-12 |
| FLIPO XENON CURING LIGHT (K994028) | Lokki | 2000-01-12 |
| SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR (K994325) | Beckman Coulter, Inc. | 2000-01-12 |
| CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES (K994043) | Biopro (M) Sdn Bhd | 2000-01-11 |
| SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS (K993954) | Beckman Coulter, Inc. | 2000-01-11 |
| BRAINLAB STEREOTACTIC ARC (K992916) | Brainlab | 2000-01-11 |
| MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM (K993971) | Micro Detect, Inc. | 2000-01-11 |
| FUJI II LC CAPSULE (K993973) | GC America, Inc. | 2000-01-11 |
| SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES (K993664) | Top Glove Sdn. Bhd. | 2000-01-11 |
| THE 4.5MM DIAMETER BICON DENTAL IMPLANT (K994037) | Bicon, Inc. | 2000-01-11 |
| BEHRING COAGULATION SYSTEM (BCS) (K992959) | Dade Behring, Inc. | 2000-01-11 |
| DENTAL HANDPIECE (K971732) | Pauline M. Nicholls | 2000-01-11 |
| FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 (K992256) | Intercontinental New Technologies, Inc. | 2000-01-11 |
| FLIPPER DETACHABLE EMBOLIZATION COIL (K993455) | Cook, Inc. | 2000-01-11 |
| ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 (K993460) | Rossmax International , Ltd. | 2000-01-11 |
| HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 (K990856) | Bird Products Corp. | 2000-01-11 |
| OHMEDA INOVENT DELIVERY SYSTEM (DEN000001) | Ohmeda Medical | 2000-01-11 |
| MDI SM TEST (K994029) | Micro Detect, Inc. | 2000-01-11 |
| 3M TR SYSTEM (K992489) | 3M Company | 2000-01-11 |
| DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE (K993465) | Depuy, Inc. | 2000-01-11 |
| MDI RF TEST (K993843) | Micro Detect, Inc. | 2000-01-11 |
| SYNEA - LS LOW-SPEED HANDPIECE (K993526) | A-Dec, Inc. | 2000-01-11 |
| RADID DRUG SCREEN 5-PANEL TEST (K993151) | American Bio Medica Corp. | 2000-01-10 |
| BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (K992767) | Albert Browne , Ltd. | 2000-01-10 |
| HARDYDISK DOXYCYCLINE, 30MCG (K994051) | Hardy Diagnostics | 2000-01-10 |