| BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER (K002868) | C.R. Bard, Inc. | 2000-12-08 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 (K002969) | Xltek | 2000-12-08 |
| AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER (K001895) | United States Surgical, A Division of Tyco Healthc | 2000-12-08 |
| ADVENT IMPLANT SYSTEM (K002614) | Core-Vent Corp. | 2000-12-08 |
| ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 (K002481) | Zcv ,Inc. | 2000-12-07 |
| INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS (K003450) | Intratherapeutics, Inc. | 2000-12-07 |
| DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 (K003448) | Irvine Scientific Sales Co., Inc. | 2000-12-07 |
| POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D (K003452) | Ep Technologies, Inc. | 2000-12-07 |
| TCM400 (K001866) | Radiometer Medical A/S | 2000-12-07 |
| AEDEFIBRILLATOR (K002232) | Medical Research Laboratories, Inc. | 2000-12-06 |
| MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) (K003483) | Lake Region Mfg., Inc. | 2000-12-06 |
| SLEEPSTRIP DISPOSABLE APNEA SCREENER (K002135) | Influent , Ltd. | 2000-12-06 |
| MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS (K002795) | Hypertec, Inc. | 2000-12-06 |
| EECP THERAPY SYSTEM, MODEL TS3 (K003469) | Vasomedical, Inc. | 2000-12-06 |
| DARDIK CAROTID SHUNT (K001621) | Vascutech, Inc. | 2000-12-06 |
| MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 (K003455) | Chad Therapeutics, Inc. | 2000-12-06 |
| STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (K001976) | OraSure Technologies, Inc. | 2000-12-06 |
| CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS (K002798) | Codman & Shurtleff, Inc. | 2000-12-06 |
| MODEL 5000 MULTIPLACE HYPERBARIC THERAPY (K002794) | Hypertec, Inc. | 2000-12-06 |
| ACAPELLA (K002768) | Dhd Healthcare Corp. | 2000-12-05 |
| UBM PLUS, MODEL P45 (K003141) | Paradigm Medical Industries, Inc. | 2000-12-05 |
| FIXION INTERLOCKING NAIL (FIXION IL NAIL) (K002783) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-05 |
| DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM (K002775) | Hand Innovations, Inc. | 2000-12-05 |
| JEWEL CAST III (K003037) | Jeneric/Pentron, Inc. | 2000-12-05 |
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 (K000582) | Abbott Diabetes Care, Inc. | 2000-12-05 |
| SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (K002105) | Siemens Medical Solutions USA, Inc. | 2000-12-05 |
| BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY (K003291) | Bayer Diagnostics Corp. | 2000-12-05 |
| GOLD CORE II (K003039) | Jeneric/Pentron, Inc. | 2000-12-05 |
| HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION (K002782) | Nuclear Diagnostics AB | 2000-12-05 |
| NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET (K001465) | Nipro Medical Corp. | 2000-12-05 |
| FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 (K003582) | Fluidsense Corp. | 2000-12-05 |
| ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (K002128) | Diagnostic Systems Laboratories, Inc. | 2000-12-05 |
| MEDIPRIME (K002894) | Algotec Systems, Ltd. | 2000-12-05 |
| URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A (K003209) | Dade Behring, Inc. | 2000-12-05 |
| ALBUMIN (K003327) | Jas Diagnostics, Inc. | 2000-12-05 |
| CLEARGLIDE PRECISION BIPOLAR DEVICE (K003587) | ETHICON, Inc. | 2000-12-04 |
| REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (K002987) | Xomed, Inc. | 2000-12-04 |
| ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D (K002749) | The Olympus Optical Co. | 2000-12-04 |
| ACETABULAR PLATES (K002941) | Encore Orthopedics, Inc. | 2000-12-04 |
| INFUSOMAT P (K003029) | B.Braun Medical, Inc. | 2000-12-04 |
| HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML (K003245) | Baxter Healthcare Corp | 2000-12-04 |
| FLUOROLAB PLUS (K002893) | Z-Kat, Inc. | 2000-12-04 |
| TKD SCALERS (K000846) | Orasystems | 2000-12-04 |
| SCITON IMAGE HAIR REMOVAL LASER (K002853) | Sciton, Inc | 2000-12-04 |
| PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES (K002884) | Fotona D.D. | 2000-12-04 |
| FERMIT N PLUS (K003377) | Ivoclar North America, Inc. | 2000-12-04 |
| SPARTAN A-10 (K002753) | Spartan Ultrasonics, Inc. | 2000-12-04 |
| NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS) (K002391) | Siam Sempermed Corp., Ltd. | 2000-12-04 |
| FERMIT PLUS (K003374) | Ivoclar North America, Inc. | 2000-12-04 |
| FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (K002761) | Fresenius Medical Care North America | 2000-12-04 |
| XPS 3000 SYSTEM (K002224) | Medtronic Xomed | 2000-12-04 |
| MODIFICATION TO INTRALASE 600C LASER KERATOME (K001211) | Intra Lase Corp. | 2000-12-04 |
| U1 HIP SYSTEM (K994078) | United Orthopedic Corp. | 2000-12-04 |
| NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (K002755) | T. Korossurgical Instruments Corp. | 2000-12-04 |
| WIRECLIP TORQUER (K003398) | Boston Scientific Corporation Northwest Technology | 2000-12-01 |
| 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING (K002807) | Acuson Corp. | 2000-12-01 |
| FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (K003445) | Fresenius Medical Care North America | 2000-12-01 |
| SIREMOBIL ISO-C 3D (K003266) | Siemens Medical Solutions USA, Inc. | 2000-12-01 |
| DEPUY C-STEM SYSTEM (K003421) | DePuy Orthopaedics, Inc. | 2000-12-01 |
| MEDCOMP BIO-CATH CATHETER LINE (K003110) | Medcomp | 2000-12-01 |
| TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 (K003276) | NuMED, Inc. | 2000-12-01 |
| PENTRA 5D (K003534) | R&D Systems, Inc. | 2000-12-01 |
| OS-2000 OPTICAL SONOGRAPHY SYSTEM (K001510) | Advanced Diagnostics, Inc. | 2000-11-30 |
| DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER (K002493) | Cobe Cardiovascular, Inc. | 2000-11-30 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (K003242) | Bio-Rad | 2000-11-30 |
| TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS (K002740) | Smith & Nephew, Inc. | 2000-11-30 |
| MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL (K003429) | Biomet, Inc. | 2000-11-30 |
| FASTPACK CALIBRATORS (K003096) | Qualigen, Inc. | 2000-11-30 |
| DISPOSABLE PRESSURE MONITOR (K003497) | Engineered Medical Systems | 2000-11-30 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (K003239) | Bio-Rad | 2000-11-30 |
| KARL STORZ HYSTEROMAT II (K000806) | KARL STORZ Endoscopy-America, Inc. | 2000-11-30 |
| COLTENE AURA COMPOMER RESTORATIVE SYSTEM (K003034) | Coltene/Whaledent, Inc. | 2000-11-30 |
| NICOLET VASOGUARD (K002766) | Nicolet Biomedical | 2000-11-30 |
| V-40/C-TAPER ADAPTER SLEEVE (K003379) | Howmedica Osteonics Corp. | 2000-11-30 |
| SENSAIRE DIAGNOSTIC SPIROMETER (K001278) | Qrs Diagnostic, LLC | 2000-11-29 |
| LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET (K003030) | Bio-Rad | 2000-11-29 |
| B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (K002938) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-11-29 |
| CAPTIA SYPHILIS-G ELISA TEST SYSTEM (K001525) | Trinity Biotech, Plc | 2000-11-29 |
| SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR (K002834) | Srs Medical Systems, Inc. | 2000-11-29 |
| NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE (K002819) | Siam Sempermed Corp., Ltd. | 2000-11-29 |
| AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH (K002721) | American Medical Systems, Inc. | 2000-11-29 |
| POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K002593) | Hartalega Sdn Bhd | 2000-11-29 |
| STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (K002010) | OraSure Technologies, Inc. | 2000-11-29 |
| ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS (K003213) | Concept Rubber Products Sdn Bhd | 2000-11-29 |
| A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 (K002986) | A.R.C. Laser AG | 2000-11-29 |
| FASTPACK CONTROL (K003095) | Qualigen, Inc. | 2000-11-29 |
| DELTA 32 AND DELTA 32 TACT (K002472) | Instrumentarium Imaging, Inc. | 2000-11-29 |
| MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS (K002781) | Medical Cables, Inc. | 2000-11-29 |
| MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 (K002787) | Palco Labs, Inc. | 2000-11-29 |
| FIRST CHECK HOME DRUG TEST PANEL 4 (K993852) | Worldwide Medical Corp. | 2000-11-29 |
| NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE (K002818) | Siam Sempermed Corp., Ltd. | 2000-11-29 |
| ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 (K000004) | Daig Corp. | 2000-11-29 |
| EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 (K002861) | Steritec Products, Inc. | 2000-11-29 |
| DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (K002262) | Diamedix Corp. | 2000-11-28 |
| PROCAD ADD-ON (K003373) | Ivoclar North America, Inc. | 2000-11-28 |
| KAVO CORUND HANDPIECE 2013 (K002708) | Kavo America | 2000-11-28 |
| SURGI-VISION PROSTATE COIL (K002916) | Surgi-Vision, Inc. | 2000-11-28 |
| ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER (K002288) | Cook, Inc. | 2000-11-28 |
| OSTEONICS ALUMINA C-TAPER HEAD (K003391) | Howmedica Osteonics Corp. | 2000-11-28 |
| ZAP DUAL CURING LIGHT (K002991) | Soft-Core Texas, Inc. | 2000-11-28 |