| HORIZON OUTLOOK WITH DOSECOM (K011975) | B.Braun Medical, Inc. | 2001-09-19 |
| PREMICRON NONABSORBABLE PET SURGICAL SUTURE (K012201) | Aesculap, Inc. | 2001-09-19 |
| TINA-QUANT TRANSFERRIN VER.2 (K012371) | Roche Diagnostics Corp. | 2001-09-19 |
| NEUROSOFT'S SOURCE (K011241) | Neurosoft, Inc. | 2001-09-19 |
| IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (K011943) | Kensey Nash Corp. | 2001-09-19 |
| M71 POWER WHEELCHAIR (K012927) | Invacare Corp. | 2001-09-19 |
| SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE (K011954) | Sulzer Orthopedics, Inc. | 2001-09-19 |
| IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (K012301) | Diagnostic Products Corp. | 2001-09-19 |
| NSI HEXED AND NON-HEXED IMPLANT SYSTEM (K003620) | Nsi | 2001-09-19 |
| WIENER LAB. UREA UV CINETICA AA (K012260) | Wiener Laboratories Saic | 2001-09-19 |
| DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 (K011944) | Smith & Nephew, Inc. | 2001-09-19 |
| RHS HELMET (K012007) | Restorative Health Svs, Inc. | 2001-09-19 |
| BIFURCATED VACCINATING NEEDLE (K012515) | Precision Medical Products, Inc. | 2001-09-19 |
| TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS (K011996) | Procter & Gamble Co. | 2001-09-19 |
| GEODESIC EEG SYSTEM, MODEL 200 (K012079) | Electrical Geodesics, Incorporated | 2001-09-19 |
| OLDELFT THORASCAN MODEL NUMBER 180T (K012165) | Nucletron Corp. | 2001-09-19 |
| AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K012154) | Aurora Imaging Technology, Inc. | 2001-09-19 |
| CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 (K012334) | Bionx Implants, Inc. | 2001-09-19 |
| LOWSLEY SUPRAPUBIC TRACTOR (K012153) | Circon Video | 2001-09-19 |
| ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE (K011087) | Orthovita, Inc. | 2001-09-19 |
| 3I CALCIUM SULFATE BONE CEMENT (K012047) | Implant Innovations, Inc. | 2001-09-19 |
| TINA-QUANT TRANSFERRIN VER.2 (K012393) | Roche Diagnostics Corp. | 2001-09-19 |
| MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP (K012124) | Johnson & Johnson Medical (China) , Ltd. | 2001-09-19 |
| MP3CF ELECTRIC WHEELCHAIR (K012802) | Merits Health Products., Inc. | 2001-09-18 |
| V*CARE MANUAL RESUSCITATOR (K012842) | Ventlab Corp. | 2001-09-18 |
| MACROPORE FX, PS, NS, LP (K012413) | Macropore Biosurgery, Inc. | 2001-09-18 |
| HEMOSIL RECOMBI PLASTIN (K012768) | Instrumentation Laboratory CO | 2001-09-18 |
| GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER (K012775) | GE Medical Systems | 2001-09-18 |
| ADVANCE MEDICAL DESIGNS FLUID POUCH (K012168) | Advance Medical Designs, Inc. | 2001-09-18 |
| DS30 HCY BLOOD COLLECTION TUBES (K012152) | Drew Scientific , Ltd. | 2001-09-18 |
| GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE (K012899) | Best Manufacturing Company | 2001-09-18 |
| G7 AUTOMATED HPLC ANALYZER (K011434) | Tosoh Medics, Inc. | 2001-09-18 |
| DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K012711) | Shijiazhuang Brilliance Plastic Co., Ltd. | 2001-09-18 |
| LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 (K012722) | Bio-Rad | 2001-09-18 |
| HARRISON HAND HELD ADJUSTING INSTRUMENT (K010851) | Harrison Cbp Seminars | 2001-09-18 |
| HANDPIECE SHEATH-MODEL #A910 (K011929) | Aaron Medical, Inc. | 2001-09-18 |
| RANDOX GENTAMICIN (K012978) | Randox Laboratories, Ltd. | 2001-09-18 |
| BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY (K012351) | Becton, Dickinson & CO | 2001-09-18 |
| CLINCARE LATEX SURGEON'S GLOVE (K012067) | Ttk Healthcare , Ltd. | 2001-09-17 |
| INFARED EAR THERMOMETER, MODEL TH8 SERIES (K011059) | Radiant Innovation, Inc. | 2001-09-17 |
| POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE (K011613) | Shield Gloves Manufacturer (M) Sdn Bhd | 2001-09-17 |
| POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS (K012558) | Matang Mfg. Sdn. Bhd. | 2001-09-17 |
| FIRST SPEP (K012032) | Bisco, Inc. | 2001-09-17 |
| MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM (K012898) | Cobe Cardiovascular, Inc. | 2001-09-17 |
| ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE (K012300) | ACON Laboratories, Inc. | 2001-09-17 |
| SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX (K011911) | Richard Wolf Medical Instruments Corp. | 2001-09-17 |
| OPUS MAGNUM ANCHOR & INSERTER (K012125) | Opus Medical, Inc. | 2001-09-17 |
| CHROMA ZONE COLOR STAIN (K012737) | Kuraray Medical, Inc. | 2001-09-14 |
| ALLERSHARP ALLERGY SKIN TESTER (K011979) | Hmb Medical Concepts, Ltd. | 2001-09-14 |
| BIOTEQUE SCALP VEIN SET (K012526) | Bioteque Corp. | 2001-09-14 |
| TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) (K012747) | Medtronic Perfusion Systems | 2001-09-14 |
| TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T (K012743) | Medtronic Perfusion Systems | 2001-09-14 |
| CLEARFIL DC CEMENT (K012735) | Kuraray Medical, Inc. | 2001-09-14 |
| CLEARFIL AP-X (K012740) | Kuraray Medical, Inc. | 2001-09-14 |
| E-STETH ELECTRONIC STETHOSCOPE (K011898) | E-Med Innovations, Inc. | 2001-09-14 |
| COPELAND MB/HA RESURFACING HUMERAL HEADS (K010827) | Biomet Orthopedics, Inc. | 2001-09-14 |
| ACTICLOT PROTEIN S, MODEL 843L (K012386) | American Diagnostica, Inc. | 2001-09-14 |
| COPELAND MB RESURFACING HUMERAL HEADS (K010657) | Biomet Manufacturing, Inc. | 2001-09-14 |
| MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (K012837) | Datex-Ohmeda | 2001-09-14 |
| TEETHMATE F-1 (K012742) | Kuraray Medical, Inc. | 2001-09-14 |
| VERTEX ETCHANT (K010849) | Apex Dental Materials, Inc. | 2001-09-14 |
| BANDVIEW SYSTEM (K012103) | Applied Spectral Imaging , Ltd. | 2001-09-14 |
| CARIES DETECTOR (K012733) | Kuraray Medical, Inc. | 2001-09-14 |
| SIMPLICITY SOFT QD MICRO INFUSION SET (K012845) | Sterling Medivations, Inc. | 2001-09-14 |
| CLEARFIL NEW BOND (K012734) | Kuraray Medical, Inc. | 2001-09-14 |
| AQUARIUSNET SERVER (K012086) | Terarecon,Inc. | 2001-09-13 |
| COLORMATE TLC BILITEST SYSTEM (K001687) | Chromatics Color Sciences Intl., Inc. | 2001-09-13 |
| SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 (K012871) | Interpore Cross Intl. | 2001-09-13 |
| OTO-CEM (K011338) | Ototech, Inc. | 2001-09-13 |
| CLEARFIL PORCELAIN BOND ACTIVATOR (K012730) | Kuraray Medical, Inc. | 2001-09-13 |
| CLEARFIL REPAIR (K012729) | Kuraray Medical, Inc. | 2001-09-13 |
| EVENCARE BLOOD GLUCOSE MONITORING SYSTEM (K011240) | Medline Industries, Inc. | 2001-09-13 |
| ESTENIA (K012707) | Kuraray Medical, Inc. | 2001-09-13 |
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |
| ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING (K012116) | Acrymed, Inc. | 2001-09-12 |
| ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 (K011980) | Pace Medical | 2001-09-12 |
| GLUCOMETER DEX TEST SENSOR (K012205) | Bayer Corp. | 2001-09-12 |
| RANDOX THERAPEUTIC DRUG CALIBRATOR (K012318) | Randox Laboratories, Ltd. | 2001-09-12 |
| SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (K012266) | National Custom Ent., Inc. | 2001-09-12 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012565) | Trek Diagnostic Systems, Inc. | 2001-09-12 |
| BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (K012262) | National Custom Ent., Inc. | 2001-09-12 |
| LIQUICHEK TDM CONTROL (K012741) | Bio-Rad | 2001-09-12 |
| RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K011945) | Polymer Technology Corp. | 2001-09-12 |
| SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM (K011857) | Synthes (Usa) | 2001-09-12 |
| ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE (K012023) | Senorx, Inc. | 2001-09-12 |
| VECTORVISION HIP (K010602) | Brainlab AG | 2001-09-12 |
| SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM (K012867) | Medison America, Inc. | 2001-09-12 |
| NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES (K011918) | Nihon Kohden America, Inc. | 2001-09-12 |
| SA6000II DIAGNOSTIC ULTRASOUND SYSTEM (K012887) | Medison America, Inc. | 2001-09-12 |
| MEDFUSION 2001 & 2010, MODEL N7215IWC (K012259) | National Custom Ent., Inc. | 2001-09-12 |
| TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K011045) | Shen Wei (Usa), Inc. | 2001-09-11 |
| STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K011066) | Smart Glove Corp. Sdn Bhd | 2001-09-11 |
| LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO (K011407) | Sempermed USA, Inc. | 2001-09-11 |
| ELEC-MATE E (K011926) | Nakanishi, Inc. | 2001-09-11 |
| DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 (K010973) | Hypoguard USA, Inc. | 2001-09-11 |
| STRATUS CS TROPONIN I CALIBRATOR (K012233) | Dade Behring, Inc. | 2001-09-11 |
| HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE (K011242) | Acusupply, Inc. | 2001-09-11 |
| SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE (K011403) | Orthogen Corp. | 2001-09-11 |
| CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE (K011848) | Circon Video | 2001-09-11 |
| ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE (K010303) | Artscan Medical Innovations | 2001-09-11 |