| AT HOME DRUG TEST, MODEL 9063 (K994237) | Phamatech | 1999-12-30 |
| AT HOME DRUG TEST, MODEL 9133 (K994236) | Phamatech | 1999-12-30 |
| THERMOCHEM-HT SYSTEM (K993330) | Hemocleanse, Inc. | 1999-12-30 |
| SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION (K993969) | Winchester Laboratories, LLC | 1999-12-30 |
| AT HOME DRUG TEST, MODEL 9078 (K994220) | Phamatech | 1999-12-30 |
| AT HOME DRUG TEST, MODEL 9083 (K994234) | Phamatech | 1999-12-30 |
| WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (K993232) | Boston Scientific Scimed, Inc. | 1999-12-30 |
| AT HOME DRUG TEST, MODEL 9068 (K994233) | Phamatech | 1999-12-30 |
| DISETRONIC D-TRON INSULIN INFUSION PUMP (K994186) | Disetronic Medical Systems | 1999-12-30 |
| AT HOME DRUG TEST, MODEL 9073 (K994219) | Phamatech | 1999-12-30 |
| RESOLVE QUICKANCHOR (K993575) | Mitek Products | 1999-12-29 |
| HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT (K992148) | Morax | 1999-12-29 |
| SULZER CARBOMEDICS CARDIOFIX PERICARDIUM (K993288) | Sulzer Carbomedics, Inc. | 1999-12-29 |
| ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 (K993542) | Rossmax International , Ltd. | 1999-12-29 |
| OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C (K993283) | Arnold & Richter Cine Technik | 1999-12-29 |
| MODUS SAGITTAL SPLIT PLATE (K993862) | The Straumann Co. | 1999-12-29 |
| INTEGRATED DIGITAL MEDICAL RECORD (IDMR) (K993338) | Ibm Israel , Ltd. | 1999-12-29 |
| LATEX SURGICAL GLOVES, PRE-POWDERED (K993450) | Fitco Dipped Products Pvt., Ltd. | 1999-12-29 |
| INVIGRA (K993693) | Indus Medicare , Ltd. | 1999-12-29 |
| MODIFICATION TO ISOLA SPINAL SYSTEM (K993030) | Depuyacromed | 1999-12-29 |
| HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC (K993621) | Pamitex Industries Sdn Bhd | 1999-12-29 |
| POWDER FREE LATEX STERILE SURGICAL GLOVES (K993562) | Tg Medical Sdn. Bhd. | 1999-12-29 |
| DISENTRONIC PENFINE INJECTION PEN NEEDLE (K994197) | Disetronic Medical Systems | 1999-12-29 |
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K992927) | Surgical Navigation Technologies, Inc. | 1999-12-29 |
| POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K993529) | Biografik (Malaysia) Sdn Bhd | 1999-12-29 |
| CADENCE DOPPLER ULTRASOUND SYSTEM (K991441) | Medasonics, Inc. | 1999-12-28 |
| CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW (K993761) | Medis Medical Imaging Systems BV | 1999-12-28 |
| BLADEWORKS DISPOSABLE ALK TUBING (K993591) | Blade Works, Inc. | 1999-12-28 |
| A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 (K991541) | A-Med Systems, Inc. | 1999-12-28 |
| URETERAL ACCESS SHEATH SET - NEW MODELS (K993650) | Applied Medical Resources | 1999-12-28 |
| NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 (K993643) | Nexan Telemed , Ltd. | 1999-12-28 |
| PASCAL MEDICAL AB MENIETT 20 (K991562) | Pascal Medical AB | 1999-12-28 |
| K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM (K990959) | Spineology, Inc. | 1999-12-27 |
| ELITE CUSTOM (K993142) | Soma Blue, Inc. | 1999-12-27 |
| DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) (K992482) | Radiancy, Ltd. | 1999-12-27 |
| VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE (K993485) | Sun Biomedical Laboratories, Inc. | 1999-12-27 |
| HARDYDISK AMIKACIN 30MCG (K993993) | Hardy Diagnostics | 1999-12-27 |
| MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. (K994149) | Bio-Logic Systems Corp. | 1999-12-27 |
| GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE (K994166) | Gyrus Medical , Ltd. | 1999-12-27 |
| SODEM PERFORATOR DRIVE (K993851) | Sodemsystems | 1999-12-27 |
| 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE (K993936) | Imagyn Surgical | 1999-12-27 |
| MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (K983860) | Polymer Technology Systems, Inc. | 1999-12-27 |
| GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 (K994075) | Geiger Medical Technologies, Inc. | 1999-12-27 |
| K-ASSAY MULTI-ANALYTE CALIBRATOR (K993853) | Kamiya Biomedical Co. | 1999-12-27 |
| CARESIDE DIRECT BILIRUBIN (K993771) | Careside, Inc. | 1999-12-27 |
| VITALITY SYSTEM (K993143) | Soma Blue, Inc. | 1999-12-27 |
| SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST (K992949) | Drug Detection Devices, Ltd. | 1999-12-27 |
| MPM REGENECARE WOUND GEL (K992074) | Mpm Medical., Inc. | 1999-12-23 |
| FASTSEAL CHEST WOUND DRESSING (K990079) | Greenfield Medical Technologies, Inc. | 1999-12-23 |
| OMNICORDER BIOSCAN SYSTEM (K990416) | Omnicorder Technologies, Inc. | 1999-12-23 |
| SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM (K993731) | Siemens Medical Solutions USA, Inc. | 1999-12-23 |
| THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP (K993424) | Y-Clip Associates | 1999-12-23 |
| SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY (K993209) | Thermolase Corp. | 1999-12-23 |
| S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K994068) | Cordis Corp. | 1999-12-23 |
| PHARMASEED, MODEL BT-125-1 (K992008) | Syncor Pharmaceuticals, Inc. | 1999-12-23 |
| DUCPREP BREAST ASPIRATOR, MODEL PMPO2 (K993342) | Windy Hill Technology, Inc. | 1999-12-23 |
| O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER (K993651) | Sc Hennig Enterprises Europe Srl | 1999-12-23 |
| MODULAR REACH HIP (K994038) | Biomet, Inc. | 1999-12-22 |
| SPO2 WRAP SENSOR (K992211) | Epic Medical Equipment Services, Inc. | 1999-12-22 |
| 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH (K992402) | Telemed Systems, Inc. | 1999-12-22 |
| EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (K992587) | Stellar Bio Systems, Inc. | 1999-12-22 |
| PARAGON LENS VIAL (K993487) | Paragon Vision Sciences | 1999-12-22 |
| PARAGON LENS CARRIER (K993486) | Paragon Vision Sciences | 1999-12-22 |
| HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD (K992390) | Telemed Systems, Inc. | 1999-12-22 |
| GUGLIELMI DETACHABLE (GDC) (K991139) | Boston Scientific, Target | 1999-12-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS (K994145) | Ortho-Clinical Diagnostics, Inc. | 1999-12-22 |
| SOLITAIRE 2 (K993932) | Heraeus Kulzer, Inc. | 1999-12-22 |
| STAT-SHELL DISPOSABLE SPO2 SENSOR (K992092) | Epic Medical Equipment Services, Inc. | 1999-12-22 |
| ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB (K994039) | Abbott Laboratories | 1999-12-22 |
| ENIGMA HI-BASE DENTURE BASE MATERIAL (K993717) | Davis Schottlander & Davis, Ltd. | 1999-12-22 |
| SPACE-OR RETRACTOR (K993544) | Advanced Surgical Concepts (Asc) | 1999-12-22 |
| RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE (K993796) | American Bio Medica Corp. | 1999-12-21 |
| SNN FLUORO NAVIGATION SYSTEM (K993673) | I.S.G. Technologies, Inc. | 1999-12-21 |
| BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (K991074) | Intracel Corp. | 1999-12-21 |
| UNI-GOLD H. PYLORI (K991697) | Trinity Biotech, Plc | 1999-12-21 |
| PENSIL TRAUMA, MODEL WWS6100 (K993962) | Wuestec Medical, Inc. | 1999-12-21 |
| CG-2100 ECG TRANSMITTER (K994009) | Card Guard Scientific Survival , Ltd. | 1999-12-21 |
| CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K (K993812) | Hardy Diagnostics | 1999-12-21 |
| AXIS %CDT TURBIDIMETRIC IMMUNOASSAY (K992502) | Axis | 1999-12-21 |
| HEMOCHEK-A1C SAMPLE COLLECTION KIT (K990899) | Osborn Group, Inc. | 1999-12-21 |
| FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET (K993590) | Pointe Scientific, Inc., | 1999-12-21 |
| MODIFICATION OF PARAPOST CEMENT (K993710) | Coltene/Whaledent, Inc. | 1999-12-21 |
| PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE (K993716) | Harry J. Bosworth Co. | 1999-12-21 |
| FIRST RESPONSE 1-STEP PREGNANCY (K992232) | Armkel, LLC | 1999-12-21 |
| BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA (K993612) | The Binding Site, Ltd. | 1999-12-21 |
| UROVIEW 2800 (K993687) | Ge Dec Medical Systems | 1999-12-21 |
| TONGUE STABILIZER DEVICE (K993381) | University of Otago | 1999-12-21 |
| SYNTHES CERVIFIX SYSTEM (K994187) | Synthes (Usa) | 1999-12-21 |
| QUANTECH TOTAL B-HCG ASSAY (K990258) | Quantech , Ltd. | 1999-12-21 |
| M-PACT CORNEAL LIGHT SHIELD (K993883) | M-Pact Corp. | 1999-12-21 |
| GRADILEIDEN V TEST (K992456) | Gradipore , Ltd. | 1999-12-21 |
| PHILIPS INTURIS DICOM RECORDER (K993227) | Philips Medical Systems North America, Inc. | 1999-12-21 |
| PATHFINDER II ANGIOGRAPHIC CATHETER (K990173) | Maxxim Medical | 1999-12-21 |
| DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI (K993935) | Wesley Jessen Corp. | 1999-12-21 |
| CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM (K993645) | Ge Medical Systems, Inc. | 1999-12-21 |
| KEELER CRYO MASTER & PROBES (K992954) | Keeler Instruments, Inc. | 1999-12-21 |
| MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE (K994175) | Sodemsystems | 1999-12-21 |
| HARDYDISK AZITHROMYCIN 15MCG (K993994) | Hardy Diagnostics | 1999-12-21 |
| KLS-MARTIN MMF SCREW (K980760) | KLS-Martin L.P. | 1999-12-21 |
| LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET (K994110) | Diasorin/American Standard Companies | 1999-12-21 |