| BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 (K000743) | Boston Scientific Scimed, Inc. | 2000-09-06 |
| EXPLORER GRADIENT (K001987) | Philips Medical Systems North America, Inc. | 2000-09-06 |
| DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 (K002655) | Meditec Co., Ltd. | 2000-09-06 |
| PHILIPS INTEGRIS ALLURA (K002016) | Philips Medical Systems North America, Inc. | 2000-09-06 |
| GYROSCAN INTERA (R7.5) (K001796) | Philips Medical Systems North America, Inc. | 2000-09-06 |
| COAGUCHEK S SYSTEM, MODEL 2138280 (K994349) | Roche Diagnostics Corp. | 2000-09-06 |
| BREEZE SLEEPGEAR WITH DREAMSEAL (K002001) | Puritan Bennett Corp. | 2000-09-06 |
| INVIDOS (K002051) | Scanditronix Medical AB | 2000-09-05 |
| OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT (K994103) | Olympus America, Inc. | 2000-09-05 |
| INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM (K002380) | Baxter Healthcare Corp | 2000-09-05 |
| PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM (K993675) | Nomos Corp. | 2000-09-05 |
| CAMIT DIABETES MANAGEMENT SOFTWARE (K001907) | Roche Diagnostics Corp. | 2000-09-05 |
| OBC-63 MEBREAST ARRAY COIL (K002602) | Mri Devices Corp. | 2000-09-05 |
| TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K002609) | Roche Diagnostics Corp. | 2000-09-05 |
| LINEZOLID, 30UG, BBL SENSI-DISC (K002165) | Dickinson, and Co. | 2000-09-05 |
| STRATO X (K002432) | Villa Sistemi Medicali S.P.A. | 2000-09-01 |
| EQUIPMENT DRAPES (K002508) | Allegiance Healthcare Corp. | 2000-09-01 |
| FENNING HIP STEM (K002441) | DePuy Orthopaedics, Inc. | 2000-09-01 |
| PARALLAX CRANIOSET (K994022) | Parallax Medical, Inc. | 2000-08-31 |
| ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 (K002453) | Beckman Coulter, Inc. | 2000-08-31 |
| LIFE SCOPE EC, MODEL BSM-1102 (K000517) | Nihon Kohden America, Inc. | 2000-08-31 |
| LINEAGE ACETABULAR SYSTEM (K002149) | Wrightmedicaltechnologyinc | 2000-08-31 |
| OLEEVA FOAM (K002109) | Bio Med Sciences, Inc. | 2000-08-31 |
| ROTAFLOW CENTRIFUGAL PUMP SYSTEM (K991864) | Jostra Medizintechnik AG | 2000-08-31 |
| IMPULSE SELECT (K001579) | Airsep Corp. | 2000-08-31 |
| SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION (K002528) | Sienco, Inc. | 2000-08-31 |
| RD-2104 (K002222) | J.F. Jelenko & Co., Inc. | 2000-08-31 |
| GAZELLE BALLOON DILATATION CATHETER (K001134) | Boston Scientific Corp | 2000-08-31 |
| VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM (K002402) | Mitek Products | 2000-08-31 |
| 3D ACTIVETRAC (K001712) | The Saunders Group | 2000-08-31 |
| VASOTRAX (K001898) | Medwave, Inc. | 2000-08-31 |
| ATHOS (K001704) | Cosmos Medical Technology | 2000-08-31 |
| TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 (K001709) | Pioneer Surgical Technology | 2000-08-31 |
| SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR (K000700) | Sensidyne, Inc. | 2000-08-31 |
| TORNIER BIPOLAR RADIAL HEAD PROSTHESIS (K994041) | Tornier, Inc. | 2000-08-31 |
| 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 (K000919) | Excel Tech. , Ltd. | 2000-08-31 |
| M2A 28MM RINGLOC LINER (K002379) | Biomet, Inc. | 2000-08-31 |
| RADIOLUCENT COLLES FRACTURE KIT (K001760) | Biomet, Inc. | 2000-08-31 |
| BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 (K002333) | Biosense Webster, Inc. | 2000-08-31 |
| VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM (K002422) | Mitek Products | 2000-08-31 |
| LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 (K002460) | Bio-Rad | 2000-08-31 |
| ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY (K001127) | The Binding Site, Ltd. | 2000-08-30 |
| JBC OPAQUE AND GLITTER (K002048) | J.B.C and Co. | 2000-08-30 |
| UTERINE TENACLUM HOOK (K001818) | Towne Brothers (Pvt.), Ltd. | 2000-08-30 |
| MODIFICATION OF ACL ADVANCE (K002400) | Instrumentation Laboratory CO | 2000-08-30 |
| TOTAL PSA MICROTITER ELISA (K002121) | Oncogene Science, Inc. | 2000-08-30 |
| SLIDESCAN (K001420) | Applied Imaging Corp. | 2000-08-30 |
| MICRO-MAX, MODEL 319 (K002404) | Tek Marketing, Inc. | 2000-08-30 |
| D. R. MEDICAL CONTROLLED PRESSURE GARMENTS (K001300) | Confection Medicale D.R., Inc. | 2000-08-30 |
| COMPLEXED PSA MICROTITER ELISA (K002313) | Oncogene Science, Inc. | 2000-08-30 |
| SPECTRUM SILICONE FOLEY CATHETER (K000251) | Cook Urological, Inc. | 2000-08-30 |
| PROTON VISION 7.0 (K002312) | Varian Medical Systems, Inc. | 2000-08-30 |
| TCD 100M, PWD13 TRANSDUCER (K002533) | Spencer Technologies | 2000-08-30 |
| PURILENS SALINE SOLUTION (K002319) | Purilens, Inc. | 2000-08-30 |
| OBC-096 BREAST ARRAY COIL (K002539) | Mri Devices Corp. | 2000-08-30 |
| MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM (K994283) | Medis Medical Imaging Systems BV | 2000-08-30 |
| MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX (K001052) | Med-Tec,Inc. | 2000-08-30 |
| FORAMATRON V, MODEL D680 (K002195) | Parkell, Inc. | 2000-08-30 |
| NEUROVASCULAR ARRAY COIL (K001946) | Ge Medical Systems, Inc. | 2000-08-30 |
| LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) (K002536) | Bio-Rad | 2000-08-30 |
| LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 (K002535) | Bio-Rad | 2000-08-30 |
| MINOLTA PULSOX-3/MINOLTA PULSOX-3I (K984570) | In-X Corp. | 2000-08-30 |
| MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER (K001338) | Boston Scientific Corp | 2000-08-30 |
| SMITH & NEPHEW OFF-CENTERED PORP (K002464) | Gyrus Ent LLC | 2000-08-29 |
| DEPUY NEUFLEX PIP FINGER (K001922) | Depuy, Inc. | 2000-08-29 |
| NEOCONTROL PELVIC FLOOR THERAPY SYSTEM (K001903) | Neotonus, Inc. | 2000-08-29 |
| VECTOR TARGETING SYSTEM (K001938) | Vector Medical, Inc. | 2000-08-29 |
| AVID-NIT LOSS OF RESISTANCE SYRINGE (K001731) | Avid Medical, Inc. | 2000-08-29 |
| CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) (K002401) | Advanced Sterilization Products | 2000-08-29 |
| MODULAR PORP AND TORP MODEL TBD (K002378) | Gyrus Ent LLC | 2000-08-29 |
| PSI SKULL CLAMP (K002276) | V. Mueller Neuro/Spine | 2000-08-29 |
| PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 (K002138) | Maersk Medical A/S | 2000-08-29 |
| RIGID GAS PERMEABLE CONTACT LENS (K001960) | Polymer Technology | 2000-08-28 |
| FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS (K991495) | Fluid Process Systems, Inc. | 2000-08-28 |
| IMPROVED TRY-IN GEL (K001899) | Sybron Dental Specialties, Inc. | 2000-08-28 |
| INTRASTENT DOUBLESTRUT PARAMOUNT (K001648) | Intratherapeutics, Inc. | 2000-08-28 |
| FLUOROTEX II SURGICAL MESH (K002351) | Bridger Biomed, Inc. | 2000-08-26 |
| CERAMIX PORCELAIN SYSTEM (K000983) | C-Mix | 2000-08-26 |
| CAPELLA (K002200) | Madsen Electronics, Inc. | 2000-08-25 |
| 2.4MM CORTEX SCREW, SELF-TAPPING (K002271) | Synthes (Usa) | 2000-08-25 |
| RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE (K000808) | Rich-Mar Corp. | 2000-08-25 |
| HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L (K994198) | Toray Industries (America), Inc. | 2000-08-25 |
| ULTIMA SMARTBELT, MODEL 0560 (K001743) | Braebon Medical Corp. | 2000-08-25 |
| COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS (K002491) | Medison Co., Ltd. | 2000-08-25 |
| POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM (K001681) | Smv America | 2000-08-25 |
| REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 (K001923) | Gendron, Inc. | 2000-08-25 |
| LACTOSORB MENISCAL SCREW (K002020) | Biomet Manufacturing, Inc. | 2000-08-25 |
| XIMX SYSTEM (K002100) | Medical Manager Research Development | 2000-08-25 |
| MODEL 9000 BARIATRIC WHEELCHAIR (K002317) | Invacare Corp. | 2000-08-25 |
| EHC500 DESKTOP PATIENT STATION, MODEL EHC500 (K002388) | Cybercare, Inc. | 2000-08-25 |
| KARMAN WHEELCHAIR (K002167) | Karman Healthcare, Inc. | 2000-08-25 |
| C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 (K000354) | Warepalmy Enterprise, LLC (Usa) | 2000-08-25 |
| KARMAN WHEELCHAIR (K002202) | Karman Healthcare, Inc. | 2000-08-25 |
| FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN (K002129) | Ferris Mfg. Corp. | 2000-08-25 |
| NLITE SYSTEM, SLS MODEL NUMBER A00-1025 (K000811) | Sls Biophile , Ltd. | 2000-08-25 |
| SPINA SYSTEM (K002260) | North American Medical Corporation (Nam) | 2000-08-25 |
| TITAN POROCOAT HIP PROSTHESIS (K001991) | DePuy Orthopaedics, Inc. | 2000-08-25 |
| BIOLOK SCREW (K002070) | Biocomposites, Ltd. | 2000-08-25 |
| AERONEB II, MODEL APN 200 (K992831) | Aerogen, Inc. | 2000-08-25 |
| PLAINSENSE WHEELCHAIR (K001909) | Plainsense Wheelchairs, Inc. | 2000-08-25 |