| Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (K003576) | Quinton, Inc. | 2001-01-25 |
| DR180+OXY (K004007) | North East Monitoring, Inc. | 2001-01-25 |
| STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD (K003696) | Dade Behring, Inc. | 2001-01-25 |
| WELCH ALLYN 11800 OPTHALMOSCOPE (K003376) | Welch Allyn, Inc. | 2001-01-25 |
| STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE (K001961) | Stoeckert Instrumente | 2001-01-25 |
| PVA FOAM EMBOLIZATION PARTICLES (K001678) | Surgica Corp. | 2001-01-25 |
| HARDYDISK SULFISOXAZOLE (K003690) | Hardy Diagnostics | 2001-01-25 |
| ELECSYS HCG STAT CLASET II (K003941) | Roche Diagnostics Corp. | 2001-01-25 |
| GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 (K001624) | Gebauer Co. | 2001-01-25 |
| INTRODEUCE DOUBLE LUMEN INTRODUCER (K001985) | Cook, Inc. | 2001-01-25 |
| IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY (K004013) | Implex Corp. | 2001-01-25 |
| ZINC PHOSPHATE CEMENT (K003427) | Rite-Dent Manufacturing Corp. | 2001-01-24 |
| THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE (K994060) | Bioplate, Inc. | 2001-01-24 |
| BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR (K991618) | Propper Mfg. Co., Inc. | 2001-01-24 |
| DYRACT CEM LCI COMPOMER (K003921) | Dentsply Intl. | 2001-01-24 |
| STIMATE N601 TENS (K003487) | Everyway Medical Instruments Co.,Ltd | 2001-01-24 |
| STRYKER REMOTE SURGICAL PLANNING SYSTEM (K004027) | Stryker Instruments | 2001-01-24 |
| DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- (K010034) | Cook, Inc. | 2001-01-24 |
| PARSFIX CABLE-SCREW SYSTEM (K003351) | Spinal Concepts, Inc. | 2001-01-24 |
| NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE (K010038) | Cambridge Marketing, Inc. | 2001-01-24 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K003904) | Purna Bina Sdn Bhd | 2001-01-24 |
| SOFRADIM PARIETEX SURGICAL MESHES (K003990) | Sofradim Production | 2001-01-24 |
| INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS (K003997) | Intratherapeutics, Inc. | 2001-01-24 |
| KENDALL-LTP TURNER SAVE-A-LINE (K003511) | The Ludlow Company LP | 2001-01-24 |
| ALGINATE IMPRESSION MATERIAL (K003426) | Rite-Dent Manufacturing Corp. | 2001-01-23 |
| MEDLINE STERILIZATION WRAP (K002968) | Medline Industries, Inc. | 2001-01-23 |
| CAVEX TEMPORARY CEMENT (K003791) | Cavex Holland BV | 2001-01-23 |
| MOLINA ORBITAL MALAR DISTRACTOR (K003883) | KLS-Martin L.P. | 2001-01-23 |
| VITREA 2 CT PERFUSION OPTION (K003639) | Vital Images, Inc. | 2001-01-23 |
| MAGNETOM RHAPSODY SYSTEM (K003628) | Siemens Medical Solutions USA, Inc. | 2001-01-23 |
| HORIZONS PAPILLOTOME (K002236) | Horizons Intl. Corp. | 2001-01-23 |
| DIFFUSION TENSOR IMAGING OPTION (K003573) | Ge Medical Systems, Inc. | 2001-01-23 |
| GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K003872) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-23 |
| RITA STARBURST XLI ELECTROSURGICAL DEVICE (K010060) | Rita Medical Systems | 2001-01-23 |
| HORIZONS ERCP CANNULA (K002235) | Horizons Intl. Corp. | 2001-01-23 |
| V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT (K003042) | Joe B. Goldberg, O.D. | 2001-01-22 |
| GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM (K002621) | Apex BioTechnology Corp. | 2001-01-22 |
| EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (K003341) | Syva Co., Dade Behring, Inc. | 2001-01-22 |
| CONTOUR POLARIS URETERAL STENT (K010002) | Boston Scientific Corp | 2001-01-22 |
| NARKOMED MRI-2, MODEL NM-MRI-2 (K003579) | Draeger Medical, Inc. | 2001-01-22 |
| WAKO CRP-UL, CRP-UL CALIBRATOR SET (K003342) | Wako Chemicals USA, Inc. | 2001-01-22 |
| QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA (K003959) | Inova Diagnostics, Inc. | 2001-01-22 |
| ADVANTAGE THC/COCAINE TEST (K003708) | Advantage Diagnostics Corp. | 2001-01-22 |
| GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM (K002624) | Apex BioTechnology Corp. | 2001-01-22 |
| COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (K003323) | Davol, Inc. | 2001-01-22 |
| GLUTARTEST 1 REAGENT STRIP (K002011) | Integrated Biomedical Technology, Inc. | 2001-01-22 |
| PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW (K003459) | Philips Medical Systems North America, Inc. | 2001-01-22 |
| INSTACCULT (K002930) | Medtek Diagnostics, LLC | 2001-01-22 |
| VIEW READING STATION (K003688) | Electromed Intl., Ltd. | 2001-01-22 |
| BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY (K000884) | Becton Dickinson Biosciences | 2001-01-19 |
| ACROTHERM (K003368) | Aquarius Medical Corp. | 2001-01-19 |
| EDTA ROOT CANAL CLEANSER (K003422) | Super Glide, Inc. | 2001-01-19 |
| OTI CERAMIC FEMORAL HEAD SYSTEM (K003316) | Osteoimplant Technology, Inc. | 2001-01-19 |
| NETRA WORKSTATION AND NETRAMD SOFTWARE (K003484) | Scimage, Inc. | 2001-01-19 |
| SPLINE DENTAL IMPLANT SYSTEM (K010073) | Sulzer Calcitek, Inc. | 2001-01-19 |
| TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B (K003964) | Cordis Corp. | 2001-01-19 |
| A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR (K002061) | A&D Engineering, Inc. | 2001-01-19 |
| CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 (K003481) | Codonics, Inc. | 2001-01-19 |
| QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) (K003358) | Smv America | 2001-01-19 |
| HARDYDISK TRIMETHOPRIM 5MCG (K003554) | Hardy Diagnostics | 2001-01-19 |
| RENEW NEUROSTIMULATION SYSTEM (K000852) | Advanced Neuromodulation Systems | 2001-01-19 |
| VIVID 7 WITH SONOPAC, MODEL FB0008XX (K003931) | Ge Medical Systems, Inc. | 2001-01-18 |
| MAMMOTOME HAND HELD PROBE, MODEL MHH8 (K003297) | Ethicon Endo-Surgery, Inc. | 2001-01-18 |
| SYMPHONY GRAFT DELIVERY SYSTEM (K003286) | Depuyacromed | 2001-01-18 |
| ACTIVE ARRAY CATHETER, MODEL CS-2000 (K001097) | Image-Guided Neurologics, Inc. | 2001-01-18 |
| ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS (K003492) | Cambridge Heart, Inc. | 2001-01-18 |
| U-SYSTEMS ULTRASOUND SYSTEM USI-2000 (K003479) | U-Systems, Inc. | 2001-01-18 |
| PC FLOW + (K001528) | Spirometrics Medical Equipment Co. | 2001-01-18 |
| A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454) | Biotronik, Inc. | 2001-01-18 |
| MRI LINE MARKER (K003736) | I.Z.I. Corp. | 2001-01-18 |
| TRAK BACK II (K003938) | Jomed, Inc. | 2001-01-18 |
| SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS (K003453) | Fonar Corp. | 2001-01-18 |
| LIFEMATE HEMOFILTRATION SYSTEM (K001283) | Nxstage Medical, Inc. | 2001-01-17 |
| MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM (K003575) | GE Medical Systems | 2001-01-17 |
| COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 (K003278) | Irvine Scientific Sales Co., Inc. | 2001-01-17 |
| TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM (K003928) | Medtronic Sofamor Danek, Inc. | 2001-01-17 |
| MAXILLARY DISTRACTOR (K003393) | Synthes (Usa) | 2001-01-17 |
| LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (K003583) | Trace America, Inc. | 2001-01-17 |
| PHLEBOPUMP, MODEL 1000 (K003284) | Prevent Products, Inc. | 2001-01-17 |
| FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (K002638) | Future Diagnostics B.V. | 2001-01-17 |
| PROFILE-ER (K002331) | Medtox Diagnostics, Inc. | 2001-01-17 |
| HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG (K003556) | Hardy Diagnostics | 2001-01-17 |
| ELECSYS DHEA-S (K003174) | Roche Diagnostics Corp. | 2001-01-17 |
| X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 (K003895) | Ansell Perry | 2001-01-17 |
| ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER (K003901) | AngioDynamics, Inc. | 2001-01-17 |
| NC-STAT (K003508) | Neurometrix, Inc. | 2001-01-17 |
| HYALURONIDASE REAGENT, MODEL CAT#2212 (K003751) | Invitrocare, Inc. | 2001-01-17 |
| LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET (K003745) | Rln Systems, Inc. | 2001-01-16 |
| PATTERN RESIN (K003817) | GC America, Inc. | 2001-01-16 |
| CD-CAL PLUS CALIBRATOR (K003991) | R&D Systems, Inc. | 2001-01-16 |
| ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K003771) | Ansell Healthcare Products, Inc. | 2001-01-16 |
| HARDYDISK NAFCILLIN, 1 MCG (K003536) | Hardy Diagnostics | 2001-01-12 |
| CA 125 II CALCHECK (K003967) | Roche Diagnostics Corp. | 2001-01-12 |
| THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM (K003226) | Lifecore Biomedical, Inc. | 2001-01-12 |
| GEON DIGITAL CLINICAL THERMOMETER (K003223) | Geon Corp. | 2001-01-12 |
| E.N.S.I. RETRACTABLE SAFETY SYRINGE (K003348) | Ensi-Med International Pty. , Ltd. | 2001-01-12 |
| GUARDED NEEDLE 2000 (K003406) | International Medical Device Partners, Inc. | 2001-01-12 |
| MADA WHEELCHAIRS (K003862) | Mada Medical Products, Inc. | 2001-01-12 |
| BIOMET'S MINIMALLY CONSTRAINED ELBOW (K003253) | Biomet, Inc. | 2001-01-12 |
| ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM (K001775) | Zoe Medical, Inc. | 2001-01-12 |