| IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 (K000257) | Diagnostic Products Corp. | 2000-02-23 |
| SYNTHETIC VDRL ANTIGEN (K993633) | Centers for Disease Control and Prevention | 2000-02-23 |
| VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994318) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000-02-23 |
| ACCU-CHEK ADVANTAGE METER (K000365) | Roche Diagnostics Corp. | 2000-02-23 |
| EXEL INJECTION PLUG WITH CAP (K992290) | Exel Intl. | 2000-02-23 |
| MAGNA 5000 PHASED ARRAY CTL SPINE COIL (K000002) | Usa Instruments, Inc. | 2000-02-23 |
| PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE (K994182) | Pulpdent Corp. | 2000-02-23 |
| KAVO DIAGNODENT (DEN990002) | Kavo America | 2000-02-22 |
| SIMS PORTEX ANESTHESIA CATHETER (K994275) | Sims Portex, Inc. | 2000-02-22 |
| OXYCON PRO (K992214) | Erich Jaeger B.V. | 2000-02-22 |
| LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM (K993990) | Stryker Instruments | 2000-02-22 |
| MARSPO2, MODEL 2001 (K993979) | Novametrix Medical Systems, Inc. | 2000-02-22 |
| ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND (K000228) | Arthrocare Corp. | 2000-02-22 |
| PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR (K993976) | The Prometheus Group | 2000-02-22 |
| 10 CURIE IRDIUM 192, CSN00100-192 (K991571) | Alpha-Omega Services, Inc. | 2000-02-22 |
| SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR (K993974) | Siemens Medical Solutions USA, Inc. | 2000-02-22 |
| LEMAITRE BALLOON CATHETER WITH IRRIGATION (K992940) | Vascutech, Inc. | 2000-02-22 |
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K992461) | Surgical Navigation Technologies, Inc. | 2000-02-22 |
| PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED (K992537) | Bio-Vascular, Inc. | 2000-02-22 |
| REMOTEIMAGE SYSTEM (K994228) | Etrauma.Com Corp. | 2000-02-22 |
| SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES (K000166) | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000-02-22 |
| CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (K994021) | Strieter Clinical Research Laboratories, Inc. | 2000-02-22 |
| FLOCATH (K000070) | Rusch Intl. | 2000-02-18 |
| IBC VRV, MODEL 1350 (K992657) | International Biophysics Corp. | 2000-02-18 |
| ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 (K000132) | Pharmacia & Upjohn Co. | 2000-02-18 |
| 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER (K993966) | Arrow Intl., Inc. | 2000-02-18 |
| DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM (K994424) | Diamedix Corp. | 2000-02-18 |
| ACTION AF-1 WHEELCHAIR (K000174) | Invacare Corp. | 2000-02-18 |
| ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 (K000196) | Beckman Coulter, Inc. | 2000-02-18 |
| CONVERTORS SURGICAL GOWNS, STERILE (K994244) | Allegiance Healthcare Corp. | 2000-02-18 |
| EU-TTG IGA ELISA (K994379) | Scimedx Corp. | 2000-02-18 |
| RX G-UNIVERSAL (K000360) | Jeneric/Pentron, Inc. | 2000-02-18 |
| CRYO-HIT (K993965) | Galil Medical , Ltd. | 2000-02-18 |
| MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM (K000362) | Zeus Scientific, Inc. | 2000-02-18 |
| SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] (K994143) | Smith & Nephew, Inc. | 2000-02-18 |
| ASP-100, MODEL 2100 (K991345) | Vitrolife Sweden AB | 2000-02-18 |
| HARDYDISK, CEFAZOLIN, 30MCG (K000128) | Hardy Diagnostics | 2000-02-18 |
| MRS-TITAN (K992359) | Rotec Medizintechnik GmbH | 2000-02-18 |
| CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 (K000055) | Diagnostic Chemicals , Ltd. | 2000-02-18 |
| FRIOS MICROSAW (K994298) | Friadent GmbH | 2000-02-18 |
| MED-GUARD SURGEON'S GOWN (K992445) | Kappler USA | 2000-02-18 |
| SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES (K000156) | Shield Gloves Manufacturer (M) Sdn Bhd | 2000-02-18 |
| ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL (K994361) | Genesis Industries, Inc. | 2000-02-18 |
| ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W (K000217) | Shield Gloves Manufacturer (M) Sdn Bhd | 2000-02-18 |
| BONE GRAFT WASHER, MODEL 9090114 - 9090118 (K994122) | Danek Medical, Inc. | 2000-02-18 |
| PERCUGUARD (K992539) | Digit-Pro | 2000-02-18 |
| SPOT ENDOSCOPIC MARKER (K993951) | Chek-Med Systems | 2000-02-18 |
| MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (K000363) | Zeus Scientific, Inc. | 2000-02-18 |
| MICROSTREP PLUS PANEL, LEVOFLOXACIN (K983943) | Dade Microscan, Inc. | 2000-02-18 |
| IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY (K994076) | Implex Corp. | 2000-02-18 |
| PACIFIC HEMOSTASIS THROMBOPLASTIN D (K994100) | Pacific Hemostasis | 2000-02-18 |
| PERMACOL (K992556) | Tissue Science Laboratories, Plc | 2000-02-17 |
| HARDYDISK CEFAMANDOLE, 30MCG (K000022) | Hardy Diagnostics | 2000-02-17 |
| LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR (K991737) | Dideco S.P.A. | 2000-02-17 |
| SJM TAILOR ANNULOPLASTY RING, MODEL TARN (K000119) | St. Jude Medical, Inc. | 2000-02-17 |
| HARDYDISK OXACILLIN, 1MCG (K994134) | Hardy Diagnostics | 2000-02-17 |
| ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000295) | Ansell Perry | 2000-02-16 |
| CASTLE SERIES 100HC STEAM STERILIZERS (K994314) | Getinge/Castle, Inc. | 2000-02-16 |
| HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS) (K994432) | Hwa Teh Industrial Sdn. Bhd. | 2000-02-16 |
| MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM (K994425) | Endius, Inc. | 2000-02-16 |
| HARDYDISK NORFLOXACIN, 10MCG (K994150) | Hardy Diagnostics | 2000-02-16 |
| TMC-EASY-302 (K984565) | Tmc Magnetics & Machinery Corp. | 2000-02-16 |
| VANNA BATHING SYSTEM (K993872) | Vancare, Inc. | 2000-02-16 |
| MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 (K000379) | Medtronic Vascular | 2000-02-16 |
| SOMAVISION (K992751) | Varian Assoc., Inc. | 2000-02-16 |
| TEMPOFIT, MODEL 02693 (K994012) | Detax GmbH & Co. KG | 2000-02-16 |
| ULTRASEAL XT PLUS (K993846) | Ultradent Products, Inc. | 2000-02-16 |
| ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE (K000242) | Exactech, Inc. | 2000-02-16 |
| AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (K000159) | Agfa Corp. | 2000-02-16 |
| GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (K993332) | Gradipore , Ltd. | 2000-02-16 |
| IMPACT MODULAR TOTAL HIP SYSTEM (K000334) | Biomet, Inc. | 2000-02-16 |
| SYNERGY VLS CAP NUT MODELS 2206, 6102 (K000236) | Interpore Cross Intl. | 2000-02-16 |
| ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION (K981936) | Advanced Biomedical Devices, Inc. | 2000-02-16 |
| HARDYDISK ERYTHROMYCIN, 15MCG (K994135) | Hardy Diagnostics | 2000-02-16 |
| WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 (DEN990008) | Wallac, Inc. | 2000-02-15 |
| QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM (K991395) | Advanced Reproductive Technologies | 2000-02-15 |
| REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT (K993404) | Remed Pharma | 2000-02-15 |
| REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT (K993395) | Remed Pharma | 2000-02-15 |
| REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT (K993405) | Remed Pharma | 2000-02-15 |
| 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K992662) | Bayer Corp. | 2000-02-15 |
| MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES (K994154) | KLS-Martin L.P. | 2000-02-15 |
| REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT (K993408) | Remed Pharma | 2000-02-15 |
| REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT (K993396) | Remed Pharma | 2000-02-15 |
| VOYAGER 6.0 SOFTWARE OPTION (K000310) | Philips Medical Systems (Cleveland), Inc. | 2000-02-15 |
| LIGHTSPEED 2.0CT SCANNER SYSTEM (K000300) | Ge Medical Systems, Inc. | 2000-02-15 |
| PLR SPLINED REVISION STEM (K994184) | Biomet, Inc. | 2000-02-15 |
| QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 (K000116) | Consolidated Technologies, Inc. | 2000-02-15 |
| HMP CONTROLS (TAS) RAPIDPOINT (K994159) | Cardiovascular Diagnostics, Inc. | 2000-02-15 |
| HARDYDISK MEZLOCILLIN 75MCG (K994212) | Hardy Diagnostics | 2000-02-15 |
| WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L (K991396) | Sage Biopharma | 2000-02-15 |
| LOCON-T DISTAL RADIAL PLATE (K994061) | Wrightmedicaltechnologyinc | 2000-02-14 |
| MAGNA 5000 PHASED ARRAY CTL SPINE COIL (K994345) | Usa Instruments, Inc. | 2000-02-14 |
| GENX CULTURE DISH (K993881) | <Genx> Intl., Inc. | 2000-02-14 |
| WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 (K993903) | Whiteside Biomechanics, Inc. | 2000-02-14 |
| IDX-60 INTRAORAL X-RAY (K993958) | X-Cel X-Ray Corp. | 2000-02-14 |
| SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000 (K000170) | Conway Stuart Medical, Inc. | 2000-02-14 |
| REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT (K993390) | Remed Pharma | 2000-02-14 |
| GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) (K000185) | W. L. Gore & Associates, Inc. | 2000-02-14 |
| GENX MICROTOOLS (K993884) | <Genx> Intl., Inc. | 2000-02-14 |
| ISOCENTRIC BEAM CHECKER (K993959) | Mick Radio-Nuclear Instruments, Inc. | 2000-02-14 |