| BABY DOPPLEX 4000 (BD4000) (K001677) | Huntleigh Diagnostics , Ltd. | 2000-08-14 |
| RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE (K002112) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2000-08-14 |
| MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL (K001870) | Usa Instruments, Inc. | 2000-08-14 |
| HAC-300 HEAD ARRAY COIL (K001944) | Mri Devices Corp. | 2000-08-14 |
| INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST (K994406) | Alfa Scientific Designs, Inc. | 2000-08-14 |
| URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (K001810) | Flexsite Diagnostics, Inc. | 2000-08-14 |
| NEOLUS NEEDLE (K001572) | Terumo Europe N.V. | 2000-08-14 |
| BIO-BLOCKS (K970569) | Geistlich-Pharma | 2000-08-14 |
| DANA DIABECARE (K001604) | Sooil Development Co., Ltd. | 2000-08-14 |
| OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS (K994118) | Guilin Latex Factory | 2000-08-14 |
| PAIN CARE 2000L (K002321) | Breg, Inc. | 2000-08-14 |
| MICOR ANESTHESIA CONDUCTION KIT (K001940) | Micor, Inc. | 2000-08-11 |
| NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE (K002217) | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-11 |
| NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE (K002216) | Shanghai Champion Plastic Products Co., Ltd. | 2000-08-11 |
| BMT ANSCORE HEALTH MANAGEMENT SYSTEM (K993875) | Boston Medical Technologies, Inc. | 2000-08-11 |
| NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES (K994124) | Mapa Professional | 2000-08-11 |
| MAGIC MOBILITY 4 X 4 WHEELCHAIR (K000796) | Vestil Manufacturing Corp. | 2000-08-11 |
| GDC ULTRASOFT COIL (K002181) | Boston Scientific, Target | 2000-08-11 |
| RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER (K002114) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2000-08-11 |
| SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P (K001403) | Sigma Diagnostics, Inc. | 2000-08-10 |
| DC-TELL (K001799) | Austenal, Inc. | 2000-08-10 |
| STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB (K001565) | Edwards Lifesciences, LLC | 2000-08-10 |
| ULTIMA METAL-ON-METAL ACETABULAR CUP (K001523) | DePuy Orthopaedics, Inc. | 2000-08-10 |
| PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA (K001860) | Homedics, Inc. | 2000-08-10 |
| LIFESHIELD ADDITIVE PIERCING PIN (K002006) | Abbott Laboratories | 2000-08-10 |
| ELECSYS CA 15-3 CALCHECK (K002353) | Roche Diagnostics Corp. | 2000-08-10 |
| SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) (K994231) | Siemens Medical Corp. | 2000-08-10 |
| POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) (K002190) | Cp Medical | 2000-08-10 |
| BIOTRACE, MODEL 1730 (K002063) | Bryan Corp. | 2000-08-10 |
| CARONY (K002205) | Bruno Independent Living Aids, Inc. | 2000-08-10 |
| PROTEMP H (K002364) | Espe Dental AG | 2000-08-10 |
| MALLARD AIR OXYGEN ACCUBLENDER (K001609) | Mallard Medical, Inc. | 2000-08-10 |
| RS-4M+MUSCLE STIMULATOR (K000114) | Rs Medical | 2000-08-10 |
| PASCO MIC AND MIC/ID PANELS (K001953) | Pasco Laboratories, Inc. | 2000-08-10 |
| CLEARFIL REPAIR (K001914) | Kuraray Company, Ltd. | 2000-08-10 |
| INVACARE LIFT CHAIR (K002171) | Invacare Corp. | 2000-08-10 |
| THE FUGO BLADE (K001498) | Medisurg , Ltd. | 2000-08-10 |
| CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 (K001091) | Next Millennium Software Solutions, Inc. | 2000-08-10 |
| DC ZIRKON (K001815) | Austenal, Inc. | 2000-08-10 |
| PERMLASTIC 2 (K001655) | Kerr Corp. | 2000-08-10 |
| POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K000913) | Handsafe Products Sdn. Bhd. | 2000-08-10 |
| SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K002012) | Shijiazhuang Great Vision Plastic Products Co., LT | 2000-08-09 |
| TRUE (K993913) | Infinity Extrusion & Engineering, Inc. | 2000-08-09 |
| S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 (K002116) | Medical Device Consultants, Inc. | 2000-08-09 |
| KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 (K002221) | Heinz Kurz GmbH Medizintechnik | 2000-08-09 |
| SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K002015) | Shijiazhuang Great Vision Plastic Products Co., LT | 2000-08-09 |
| KWIKKMODEL (K001414) | R-Dental Dentalerzeugnisse GmbH | 2000-08-09 |
| QUINTON Q-STRESS, MODEL 000483 (K001492) | Quinton, Inc. | 2000-08-09 |
| GOLDFINGER DEVICE (K001162) | Mali-Tech , Ltd. | 2000-08-09 |
| HOTLINE 2 FLUID WARMER (K001764) | Sims Level 1, Inc. | 2000-08-09 |
| IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) (K000574) | Wr Medical Electronics Co. | 2000-08-09 |
| STOCKERT COMPACT SYSTEM VERSION 2.0 (K002118) | Stoeckert Instrumente | 2000-08-09 |
| MODIFICATION TO PASCO MIC AND MIC/ID PANELS (K001887) | Pasco Laboratories, Inc. | 2000-08-09 |
| MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES (K001727) | Blease Medical Equipment , Ltd. | 2000-08-09 |
| HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (K001406) | Mednet Locator, Inc. | 2000-08-08 |
| LA JOIE (K000736) | Goomi Ehwa, Inc. | 2000-08-08 |
| 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (K001978) | Thai Nippon Rubber Industry Co., Ltd. | 2000-08-08 |
| CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) (K000388) | Clearwater Colon Hydrotherapy, Inc. | 2000-08-08 |
| OR TABLE/MAGNETOM OPEN VIVA SYSTEM (K002225) | Siemens Medical Solutions USA, Inc. | 2000-08-08 |
| GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON (K001404) | Mednet Locator, Inc. | 2000-08-08 |
| ULTRAGUIDE CT-GUIDE 1010 (K002258) | Ultraguide , Ltd. | 2000-08-08 |
| SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM (K002239) | Kontron Medical Systems Sas | 2000-08-08 |
| ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K002134) | Selfcare, Inc. | 2000-08-07 |
| DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM (K001767) | Diamedix Corp. | 2000-08-07 |
| CONSENSUS KNEE SYSTEM (K001456) | Hayes Medical, Inc. | 2000-08-07 |
| LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 (K002196) | Bio-Rad | 2000-08-07 |
| INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST (K994395) | Alfa Scientific Designs, Inc. | 2000-08-07 |
| LACTOSORB PANELS AND FASTENERS (K984390) | Biomet, Inc. | 2000-08-07 |
| PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST (K001126) | Alatex Scientific, Inc. | 2000-08-07 |
| THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ (K001471) | Implex Corp. | 2000-08-07 |
| STATLYTE NA/K/CL/LI ANALYZER (K001761) | Nova Biomedical Corp. | 2000-08-07 |
| ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP (K001547) | Ab Biodisk | 2000-08-07 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K001645) | Dade Behring, Inc. | 2000-08-04 |
| STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM (K993166) | Stryker Endoscopy | 2000-08-04 |
| INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST (K994399) | Alfa Scientific Designs, Inc. | 2000-08-04 |
| ACCELERATOR RECIPROCATING CANNULA (K001803) | Byron Medical | 2000-08-04 |
| ENRAF-NONIUS SONOPULS 190 SYSTEM (K000084) | Henley Healthcare, Inc. | 2000-08-04 |
| CLEARFIL ST OPAQUER (K001913) | Kuraray Company, Ltd. | 2000-08-04 |
| BAUMER FEMORAL HEAD (K001571) | Baumer, S.A | 2000-08-04 |
| E-Z LINK CROSS CONNECTOR (K001470) | Depuyacromed | 2000-08-04 |
| XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (K992226) | Radionics, Inc. | 2000-08-04 |
| MICROTARGETING ELECTRODE (K991522) | FHC, Inc. | 2000-08-04 |
| PASCO MIC AND MIC/ID PANELS (K001721) | Pasco Laboratories, Inc. | 2000-08-04 |
| IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. (K002107) | Scimedx Corp. | 2000-08-04 |
| APEX MODULAR HIP STEM (K000788) | Apex Surgical, LLC | 2000-08-04 |
| MODEL 9000 PEDIATRIC WHEELCHAIR (K002170) | Invacare Corp. | 2000-08-04 |
| CERALAS D10 810NM LASER, MODEL CERALAS D10-60 (K001975) | Ceram Optec, Inc. | 2000-08-04 |
| AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 (K000653) | Pulmonox Medical Corp. | 2000-08-04 |
| TRIDENT ACETABULAR SHELLS: PS (K001449) | Howmedica Osteonics Corp. | 2000-08-04 |
| STRYKER TRAUMA PELVIC SET (K001614) | Howmedica Osteonics Corp. | 2000-08-04 |
| SONIC, MODEL SO-100 (K000593) | Metron Medical Australia, Pty, Ltd. | 2000-08-04 |
| ARTHREX CHONDRAL DART, MODEL AR-4005B-18 (K991971) | Arthrex, Inc. | 2000-08-04 |
| ALLEGIANCE GENESIS CONTAINER SYSTEM (K983299) | Allegiance Healthcare Corp. | 2000-08-04 |
| TORQUE INSTRUMENT, MODEL 8500 (K001476) | Spinalight, Inc. | 2000-08-04 |
| DORO HEADREST SYSTEM (K001808) | Pro-Med Instruments GmbH | 2000-08-04 |
| EEI SLUSH PAN DRAPE (K001994) | Eagle Endoscopic, Inc. | 2000-08-04 |
| STIMULAN -CALCIUM SULFATE BONE VOID FILTER (K001724) | Biocomposites, Ltd. | 2000-08-04 |
| TRIDENT ACETABULAR SHELLS: PS-HA (K001448) | Howmedica Osteonics Corp. | 2000-08-04 |
| NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL (K992133) | Newport Medical Instruments, Inc. | 2000-08-04 |
| HDL CHOLESTEROL PLUS (K000568) | Roche Diagnostics Corp. | 2000-08-04 |