| JAS URIC ACID LIQUID REAGENT (K012038) | Jas Diagnostics, Inc. | 2001-08-21 |
| RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC (K012020) | Non-Invasive Monitoring Systems, Inc. | 2001-08-21 |
| KSEA DION-GRACIA SET (K010785) | KARL STORZ Endoscopy-America, Inc. | 2001-08-21 |
| K-ASSAY D-DIMER CONTROLS (K012422) | Kamiya Biomedical Co. | 2001-08-21 |
| WECK CARDIAC PACING WIRES (K011660) | Weck Closure Systems | 2001-08-21 |
| VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 (K012118) | Maine Standards Co. | 2001-08-20 |
| TEMP 3 (K012276) | Medical Solutions, Inc. | 2001-08-20 |
| MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER (K012478) | I-Stat Corp. | 2001-08-20 |
| IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) (K012311) | Diagnostic Products Corp. | 2001-08-20 |
| CERCON CERAM (K011333) | Degussa - Ney Dental, Inc. | 2001-08-20 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T (K012295) | The Binding Site, Ltd. | 2001-08-20 |
| QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 (K011339) | Spacelabs Burdick, Inc. | 2001-08-20 |
| BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY (K010755) | Bayer Corp. | 2001-08-20 |
| VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 (K012119) | Maine Standards Co. | 2001-08-20 |
| INTERLOK / HA COPELAND RESURFACING HEADS (K010635) | Biomet, Inc. | 2001-08-20 |
| VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 (K012122) | Maine Standards Co. | 2001-08-20 |
| MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL (K012243) | Hematronix, Inc. | 2001-08-20 |
| DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (K012053) | Diamedix Corp. | 2001-08-20 |
| VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 (K012120) | Maine Standards Co. | 2001-08-20 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA (K012291) | The Binding Site, Ltd. | 2001-08-20 |
| STAT PROFILE PHOX PLUS L ANALYZER (K012058) | Nova Biomedical Corp. | 2001-08-20 |
| VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 (K012117) | Maine Standards Co. | 2001-08-20 |
| POLYTITER SYSTEM (K012163) | Polymedco, Inc. | 2001-08-20 |
| IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) (K012312) | Diagnostic Products Corp. | 2001-08-20 |
| PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 (K012451) | Welch Allyn Protocol, Inc. | 2001-08-20 |
| TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 (K012280) | Triage Medical, Inc. | 2001-08-17 |
| NIROYAL BILIARY PREMOUNTED STENT SYSTEM (K012216) | Boston Scientific Scimed, Inc. | 2001-08-17 |
| GSIBP BLOOD PRESSURE CUFF (K012553) | Globalshop, Inc. | 2001-08-17 |
| SPEEDYBELL (K010735) | Biopsybell S.A.S. | 2001-08-17 |
| WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM (K012455) | Welch Allyn, Inc. | 2001-08-17 |
| SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER (K012461) | Siemens Medical Solutions USA, Inc. | 2001-08-17 |
| ITI DENTAL IMPLANT SYSTEM (K003552) | Institut Straumann SA | 2001-08-17 |
| 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 (K011575) | Imagyn Surgical | 2001-08-17 |
| AIA-PACK BRCA, ST AIA PACK BRCA (K010796) | Tosoh Medics, Inc. | 2001-08-16 |
| AQUASENS FLUID MONITORING SYSTEM (K011069) | Davol Inc., Sub. C. R. Bard, Inc. | 2001-08-16 |
| HORIZONS INTERNATIONAL POLYPECTOMY SNARES (K011667) | Horizons Intl. Corp. | 2001-08-16 |
| PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM (K012379) | Trex Enterprises Corp. | 2001-08-16 |
| FUTURA TOPCAP NON GAMMA-2 (K011801) | Ab Ardent | 2001-08-16 |
| ABN ANEROID SPHYGMOMANOMETER (K012444) | Pt. Sugih Instrumendo Abadi | 2001-08-16 |
| FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS (K012242) | Fresenius Medical Care North America | 2001-08-16 |
| HELIOSEAL CLEAR CHROMA (K011491) | Ivoclar North America, Inc. | 2001-08-16 |
| VERTEX SEALAND L/C ORTHODONTIC SEALANT (K010547) | Apex Dental Materials, Inc. | 2001-08-16 |
| SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE (K011765) | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-16 |
| MODIFICATION TO ENVOY PATIENT MONITOR (K011784) | Mennen Medical , Ltd. | 2001-08-16 |
| IMAGINE H.E. (K012156) | Wieland Edelmetalle GmbH & Co. | 2001-08-16 |
| POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE (K012048) | Wrp Asia Pacific Sdn. Bhd. | 2001-08-16 |
| INFANT OXYGEN TREATMENT HOOD (K011565) | Gulf Coast Hyperbarics, Inc. | 2001-08-16 |
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |
| SPIRAL RADIUS 90-D SST SYSTEM (K012273) | United States Surgical, A Division of Tyco Healthc | 2001-08-15 |
| CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X (K012209) | Terumo Cardiovascular Systems Corp. | 2001-08-15 |
| AMEDA HYGIENIKIT (K011519) | Hollister, Inc. | 2001-08-15 |
| MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE (K012395) | Oridion Medical 1987 , Ltd. | 2001-08-15 |
| MAC-LINE CO2 NASAL CANNULA SAMPLE LINE (K012391) | Oridion Medical 1987 , Ltd. | 2001-08-15 |
| ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH (K991822) | Dr. Ihde Dental AG Switzerland | 2001-08-15 |
| VHS PEDIATRIC HIP SCREW SYSTEM (K011603) | Walter Abendschein, M.D. | 2001-08-15 |
| ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE (K012394) | Oridion Medical 1987 , Ltd. | 2001-08-15 |
| DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 (K002992) | Medtronic Functional Diagnostics A/S | 2001-08-15 |
| SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES (K011803) | Trek Diagnostic Systems, Inc. | 2001-08-15 |
| 3T L. V. CONTROL VALVE (K001245) | 3t Medical Systems, LLC | 2001-08-15 |
| FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY (K011679) | Embryotech Laboratories, Inc. | 2001-08-15 |
| MAXIM RPG PS FEMORAL COMPONENT (K012348) | Biomet, Inc. | 2001-08-15 |
| MODIFICATION TO AEQUALIS SHOULDER SYSTEM (K012212) | Tornier | 2001-08-15 |
| THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY (K011210) | Rusch Intl. | 2001-08-15 |
| NURSE'S ASSISTANT O.R. CONTROL SYSTEM (K010754) | Valmed Corp. | 2001-08-15 |
| NORMED MANDIBULAR FIXATION SYSTEM (K010118) | Osteomedics, Inc. | 2001-08-14 |
| HCG STAT PAK ULTRA-FAST (K011550) | Chembio Diagnostic Systems, Inc. | 2001-08-14 |
| MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD (K012460) | Medtronic Vascular | 2001-08-14 |
| CG-3250 MINIRECEIVER (K012187) | Card Guard Scientific Survival , Ltd. | 2001-08-14 |
| CORERESTORE 2 (K011798) | Sybron Dental Specialties, Inc. | 2001-08-14 |
| MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL (K011608) | Medical Advances, Inc. | 2001-08-14 |
| MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD (K012452) | Medtronic Vascular | 2001-08-14 |
| BAUMER LOCKING NAIL (K011504) | Baumer, S.A | 2001-08-14 |
| SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES (K011717) | Sunmax Enterprise Shanghai Co. , Ltd. | 2001-08-14 |
| HNC-127 NEUROVASCULAR ARRAY COIL (K012353) | Mri Devices Corp. | 2001-08-14 |
| MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD (K012454) | Medtronic Vascular | 2001-08-14 |
| MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD (K012458) | Medtronic Vascular | 2001-08-14 |
| ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES (K011721) | Allegiance Healthcare Corp. | 2001-08-14 |
| PACEART TX3 CARDIAC EVENT RECORDER (K012407) | Paceart, Inc. | 2001-08-14 |
| MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) (K012289) | Elekta Oncology Systems, Ltd. | 2001-08-14 |
| MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE (K012459) | Medtronic Vascular | 2001-08-14 |
| DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) (K010399) | Diatek, Inc. | 2001-08-14 |
| SURE CHECK PREGNANCY TEST (K011551) | Chembio Diagnostic Systems, Inc. | 2001-08-14 |
| FHC MICROTARGETING DRIVE SYSTEM (K011992) | FHC, Inc. | 2001-08-14 |
| GULLIVER AND CLASSE A (K012213) | American Dental Technologies, Inc. | 2001-08-13 |
| EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL (K011878) | Syva Co. | 2001-08-13 |
| BACK-UP MEIER GUIDEWIRE (K011906) | Boston Scientific Corp | 2001-08-13 |
| INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (K011514) | Kencap , Ltd. | 2001-08-13 |
| INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS (K011184) | Intratherapeutics, Inc. | 2001-08-13 |
| COOK ZILVER BILIARY STENT (K010242) | Cook, Inc. | 2001-08-13 |
| OSMED TISSUE EXPANDER (K010852) | Iop, Inc. | 2001-08-13 |
| SPERMCATCH (K011607) | Nidacon International AB | 2001-08-10 |
| MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM (K012239) | Hitachi Medical Corp. | 2001-08-10 |
| HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 (K011928) | Northgate Technologies, Inc. | 2001-08-10 |
| SIMPLICITY EURO QD INFUSION SET (K012330) | Sterling Medivations, Inc. | 2001-08-10 |
| BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 (K012369) | Atys Medical | 2001-08-10 |
| OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 (K011484) | Olympus Optical Co., Ltd. | 2001-08-10 |
| DIGORA PCT (K012170) | Soredex Palodex Group OY | 2001-08-10 |
| SMARTWAVE IF 2000 (K003631) | Newwave Medical, LLC | 2001-08-10 |
| CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 (K011496) | Richard Wolf Medical Instruments Corp. | 2001-08-10 |
| MP3U, POWER WHEELCHAIR (K011513) | Merits Health Products., Inc. | 2001-08-10 |