| ONTRAK TESTCUP 501, MODEL 3016633 (K001421) | Roche Diagnostics Corp. | 2000-07-12 |
| NUMED Z-5 ATRIOSEPTOSTOMY CATHETER (K001804) | NuMED, Inc. | 2000-07-12 |
| EBI ANTERIOR CERVICAL PLATE SYSTEM (K001794) | Ebi, L.P. | 2000-07-12 |
| APEX FIXATION PINS (K001886) | Howmedica Osteonics Corp. | 2000-07-12 |
| PASCO MIC AND MIC/ID PANELS (K001516) | Pasco Laboratories, Inc. | 2000-07-12 |
| AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO (K001502) | Erich Jaeger GmbH | 2000-07-12 |
| MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (K001891) | Bio/Data Corp. | 2000-07-12 |
| NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE (K001837) | Shanghai Poseidon Plastic Products Co., Ltd. | 2000-07-11 |
| PUMA DENTAL CHAIR AND UNIT (K000837) | Castellini S.P.A. | 2000-07-11 |
| STERICHEK TOTAL CHLORINE REAGENT STRIPS (K001194) | Environmental Test Systems, Inc. | 2000-07-11 |
| SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) (K001324) | Neuro Scan Labs | 2000-07-11 |
| SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K001861) | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-07-11 |
| SCULPTURE FLOW (K001623) | Jeneric/Pentron, Inc. | 2000-07-11 |
| BIOINSULATED SILICONE PUNCTUM PLUG (K001234) | Advanced Vision Science | 2000-07-11 |
| CD HORIZON SPINAL SYSTEM (K001255) | Medtronic Sofamor Danek, Inc. | 2000-07-11 |
| NEEDLELESS TRANSFER DEVICE (K001831) | Medimop Medical Projects, Ltd. | 2000-07-11 |
| INSIDE VIEW (K001217) | Monadnock Optics, Inc. | 2000-07-11 |
| THE KALIX IMPLANT (K001231) | New Deal, S.A. | 2000-07-11 |
| INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM (K990144) | Intuitive Surgical, Inc. | 2000-07-11 |
| KLINIDRAPE REINFORCED SURGICAL GOWNS (K000902) | Molnlycke Health Care, Inc. | 2000-07-11 |
| SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES (K001863) | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-07-11 |
| OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K001214) | Alcon Universal, Ltd. | 2000-07-10 |
| PRONOVA NONABSORBABLE SUTURE, USP (K001625) | ETHICON, Inc. | 2000-07-10 |
| ONTRAK TESTCUP PRO-5, MODEL 1986678 (K001356) | Roche Diagnostics Corp. | 2000-07-10 |
| INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST (K994409) | Alfa Scientific Designs, Inc. | 2000-07-10 |
| PEDIATRIC REFERENCE DATA (K001812) | Lunar Corp. | 2000-07-10 |
| SENSATION -VACUUM ASSIST DEVICES (K000124) | Prosurg, Inc. | 2000-07-10 |
| BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (K001902) | Gyrus Ent LLC | 2000-07-10 |
| DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM (K001707) | Diamedix Corp. | 2000-07-07 |
| PANORET, MODEL 1000A (K001111) | Cmt Medical Technologies, Ltd. | 2000-07-07 |
| SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 (K001063) | Baxter Healthcare Corp | 2000-07-07 |
| SNIPER, MODEL OR-3872XX SERIES (K001251) | Nipro Medical Corp. | 2000-07-07 |
| THE V-BAG (K001822) | Circulatory Technology, Inc. | 2000-07-07 |
| POROCOAT PRODIGY HIP PROSTHESIS (K001778) | DePuy Orthopaedics, Inc. | 2000-07-07 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET (K001156) | Gambro Renal Products | 2000-07-07 |
| IM-9B MICROINJECTORS (K001912) | Narishige Co., Ltd. | 2000-07-07 |
| IM-9A MICROINJECTORS (K001911) | Narishige Co., Ltd. | 2000-07-07 |
| CARDEON ASCENDING BALLOON CANNULA (ABC) (K001371) | Cardeon Corp. | 2000-07-07 |
| IM-9C MICROINJECTORS (K001910) | Narishige Co., Ltd. | 2000-07-07 |
| OPI BAND (K001167) | Orthomerica Products, Inc. | 2000-07-07 |
| EXTERNAL FIXATION ANCHOR PIN (K001228) | Immedica, Inc. | 2000-07-07 |
| CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT (K000062) | Cordis Corp. | 2000-07-07 |
| SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM (K001320) | Sulzer Orthopedics, Inc. | 2000-07-07 |
| RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (K001143) | Rochester Medical Corp. | 2000-07-07 |
| MODIFICATION TO PROMPT L-POP (K001494) | Espe Dental AG | 2000-07-07 |
| FLUORO-TEX CARDIOVASCULAR PATCH (K994032) | Bridger Biomed, Inc. | 2000-07-07 |
| ULTRA V THERAPEUTIC ULTRASOUND (K001166) | Excel Tech. , Ltd. | 2000-07-07 |
| MEDISANA DIGITAL TENS (K994265) | Fuji Dynamics Limited | 2000-07-06 |
| LUNAR REPORT GENERATOR II (K001756) | Lunar Corp. | 2000-07-06 |
| HITACHI AIRIS II (K001334) | Hitachi Medical Systems America, Inc. | 2000-07-06 |
| MODIFICATION TO E-SCAN (K001894) | Biosound Esaote, Inc. | 2000-07-06 |
| LIFERX (K001596) | Bowdengs Technologies, LLC | 2000-07-06 |
| LOOP ELECTRODE, BALL ELECTRODE (K993527) | Palm Medical USA, Inc. | 2000-07-06 |
| PROLONG, MODELS PL50, PL100, PL150 (K001129) | Life-Tech Intl., Inc. | 2000-07-06 |
| SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K001789) | W. L. Gore & Associates, Inc. | 2000-07-06 |
| LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA (K001772) | Taracan Pty. , Ltd. | 2000-07-06 |
| FDTENS 2010 (K994266) | Fuji Dynamics Limited | 2000-07-06 |
| CRYSTAL-EEG MODEL 15 (K001110) | Cleveland Medical Devices, Inc. | 2000-07-05 |
| TISSOMAT AND SPRAY SET (K981089) | Baxter Healthcare Corp | 2000-07-05 |
| BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A (K001770) | Bci, Inc. | 2000-07-05 |
| DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE (K001432) | Shanghai PM Plastics Ent. Co., Ltd. | 2000-07-05 |
| R&D PROJECT DW269#25 (K001469) | Ivoclar North America, Inc. | 2000-07-05 |
| CORRECT PLUS (K001218) | Jeneric/Pentron, Inc. | 2000-07-05 |
| POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001165) | Medipure Corporation (M) Sdn. Bhd. | 2000-07-05 |
| DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) (K001758) | Medical Analysis Systems, Inc. | 2000-07-05 |
| POWDERED PATIENT EXAMINATION GLOVES, LATEX (K001715) | Fitco Dipped Products Pvt., Ltd. | 2000-07-05 |
| ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S (K001418) | Procera Sandvik, Inc. | 2000-07-05 |
| GRADIA (K001518) | GC America, Inc. | 2000-07-05 |
| DANIELS SHARPSMART REUSABLE SHARPS CONTAINER (K001337) | The Daniels Corp. | 2000-07-05 |
| RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (K001430) | Vortran Medical Technology 1, Inc. | 2000-07-05 |
| SUPREMCAST V (K001383) | American Dent-All, Inc. | 2000-07-05 |
| KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION (K000901) | Molnlycke Health Care, Inc. | 2000-07-05 |
| INSTANT-VIEW MORPHINE URINE CASSETTE TEST (K994404) | Alfa Scientific Designs, Inc. | 2000-07-05 |
| COMFORT STIM (K001117) | R & D Medical Products, Inc. | 2000-07-05 |
| AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) (K001137) | Trudell Medical Int'L | 2000-07-05 |
| MALLINCKRODT, GOODKNIGHT 418S (K001845) | Mallinckrodt Developpement France | 2000-07-05 |
| IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE (K983667) | Ionics Medical Corp. | 2000-07-05 |
| OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 (K001235) | Alcon Universal, Ltd. | 2000-07-03 |
| OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (K001848) | Omron Healthcare, Inc. | 2000-07-03 |
| 6F & 7F INTRODUCING CATHETERS (MODIFICATION) (K001135) | Cordis Corp. | 2000-07-03 |
| BIOSCANNER TRIGLYCERIDES TEST STRIPS (K000586) | Polymer Technology Systems, Inc. | 2000-07-03 |
| EZ LDL CHOLESTEROL TEST SYSTEM (K993741) | Sigma Diagnostics, Inc. | 2000-07-03 |
| SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K001862) | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-06-30 |
| WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) (K001103) | Excel Tech. , Ltd. | 2000-06-30 |
| COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 (K001664) | Agilent Technologies, Inc. | 2000-06-30 |
| PERFORMER 30 HPS (K001322) | Cornelia Damsky, Inc. | 2000-06-30 |
| DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K001611) | Shanghai PT Plastics Enterprise Company, Ltd. | 2000-06-30 |
| ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 (K001671) | Omron Healthcare, Inc. | 2000-06-30 |
| AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE (K001722) | Agilent Technologies Deutschland GmbH | 2000-06-30 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 (K001101) | Excel Tech. , Ltd. | 2000-06-30 |
| UNICORN MODEL SYS0630 (K001888) | Danish Diagnostic Development A/S | 2000-06-30 |
| AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 (K001670) | Omron Healthcare, Inc. | 2000-06-30 |
| OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 (K001095) | Teledyne Analytical Instruments | 2000-06-30 |
| STEATHSTATION TREATMENT GUIDANCE PLATFORM (K001801) | Medtronic Surgical Navigation | 2000-06-30 |
| NORMOCARB STERILE BICARBONATE RENAL DIALYSIS (K001059) | Novex Pharma | 2000-06-30 |
| SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K001834) | Shijiazhuang Hongxiang Plastics Products Co; , Ltd. | 2000-06-30 |
| VSCORE WITH EKG SIGNAL GATING (K001682) | Vital Images, Inc. | 2000-06-30 |
| HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR (K000952) | Pamitex Industries Sdn Bhd | 2000-06-30 |
| GENYX FLEXIBLE INJECTION NEEEDLE (K001146) | Geny Medical, Inc. | 2000-06-30 |
| POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR (K001674) | Pamitex Industries Sdn Bhd | 2000-06-30 |