| VORTEX (K012097) | Ultravisual Medical Systems | 2001-07-12 |
| IMMOBILIZATION SYSTEM FOR ENT (K003779) | Arplay Medical S.A. | 2001-07-12 |
| MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B (K011395) | Medtronic Vascular | 2001-07-12 |
| VACUETTE SAFETY BLOOD COLLECTION SET (K011786) | Greiner Vacuette North America, Inc. | 2001-07-12 |
| PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS (K011557) | NuMED, Inc. | 2001-07-12 |
| LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 (K011867) | Bio-Rad | 2001-07-12 |
| MODIFIED M-IV MAMMOGRAPHY SYSTEM (K011987) | Lorad, A Hologic Co. | 2001-07-11 |
| DEVILBISS 9000 SERIES CPAP, MODEL 9001 (K011229) | Sunrise Medical Hhg, Inc. | 2001-07-11 |
| TELEPAX (K011173) | Imed Systems & Consulting, LLC | 2001-07-11 |
| VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 (K003551) | Jostra AG | 2001-07-11 |
| SIGN IM NAIL (K011129) | Sign, Inc. | 2001-07-11 |
| MACROPOREPX PEDIATRIC SYSTEM (K002207) | Macropore Biosurgery, Inc. | 2001-07-11 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K011851) | Masimo Corp. | 2001-07-11 |
| SCS DT-02 TRANSVERSE CONNECTOR (K003823) | Ortho Tec, LLC | 2001-07-11 |
| RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE (K011825) | Sightline Technologies , Ltd. | 2001-07-11 |
| SURGICAL DRAPES (K011422) | Advance Medical Designs, Inc. | 2001-07-10 |
| OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT (K011138) | Biomet, Inc. | 2001-07-10 |
| MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX (K011997) | Pajunk GmbH | 2001-07-10 |
| EAR THERMOMETER, MODELS ST613C AND ST613F (K011254) | Mesure Technology | 2001-07-10 |
| SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT (K010748) | Beckman Coulter, Inc. | 2001-07-10 |
| ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 (K011205) | Isoaid | 2001-07-10 |
| LUTE; CORE (K011517) | First Scientific Limited | 2001-07-10 |
| ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) (K011808) | Asia-Med GmbH and CO KG | 2001-07-10 |
| POWDERED BLUE NITRILE EXAMINATION GLOVES (K011924) | Seltom Pacific Sdn. Bhd. | 2001-07-10 |
| POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES (K011293) | Multisafe Sdn. Bhd. | 2001-07-10 |
| CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE (K011497) | Tillotson Healthcare Corp. | 2001-07-10 |
| UROLOGIC (K011311) | Pck Electronic Industry and Trade Co, Ltd. | 2001-07-10 |
| BIS ENGINE (K011834) | Aspect Medical Systems, Inc. | 2001-07-10 |
| POWDER FREE LATEX EXAMINATION GLOVES (K010546) | Jb Star Sdn Bhd | 2001-07-10 |
| SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K011882) | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001-07-10 |
| S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- (K001962) | Bescon Co., Ltd. | 2001-07-09 |
| CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 (K003254) | Mission Medicl Devices | 2001-07-09 |
| ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE (K010841) | ACON Laboratories, Inc. | 2001-07-09 |
| QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA (K011566) | Inova Diagnostics, Inc. | 2001-07-09 |
| EASY CONTROL MICRO INSERTER, MODEL ON385 (K011498) | Ophtec USA, Inc. | 2001-07-09 |
| GUIDEWIRE INTRODUCER SAFETY NEEDLE (K011085) | Medamicus, Inc. | 2001-07-09 |
| TGL FLEX REAGENT CARTRIDGE (K010871) | Dade Behring, Inc. | 2001-07-09 |
| GASTRIC SUCTION AND DRAINAGE CATHETER (K002838) | Bioenterics Corp. | 2001-07-09 |
| CANDELA SPTL-1E PULSED DYE LASER (K011092) | Candela Corp. | 2001-07-09 |
| BRAIDED GUIDING INTRODUCER (K004026) | Thomas Medical Products, Inc. | 2001-07-09 |
| BW ACUPUNCTURE NEEDLES (K011669) | H F Intl. Co. | 2001-07-09 |
| COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K011342) | Beckman Coulter, Inc. | 2001-07-09 |
| MMODIFICATION TO LAMINARIA (K011512) | A & A Medical, Inc. | 2001-07-09 |
| TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B (K011864) | Medtronic Vascular | 2001-07-09 |
| CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X (K011804) | Terumo Cardiovascular Systems Corp. | 2001-07-09 |
| POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH (K011895) | Pwa Industries Sdn. Bhd. | 2001-07-09 |
| US SENSOR #CG-930P; TOCO SENSOR CG-940P (K003876) | Card Guard Scientific Survival , Ltd. | 2001-07-09 |
| S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- (K002099) | Bescon Co., Ltd. | 2001-07-09 |
| MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS (K011117) | Mps Acacia | 2001-07-09 |
| SPINE WORKS COLLAR (K003662) | Spine Works | 2001-07-09 |
| TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX (K010235) | Oriental System Technology, Inc. | 2001-07-09 |
| QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA (K011570) | Inova Diagnostics, Inc. | 2001-07-09 |
| BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( (K011728) | Brightway Holdings Sdn. Bhd. | 2001-07-09 |
| DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K011482) | Wrp Asia Pacific Sdn. Bhd. | 2001-07-09 |
| VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI (K011668) | Oridion Medical 1987 , Ltd. | 2001-07-09 |
| JAS CALCIUM (ARSENAZO) REAGENT (K011441) | Jas Diagnostics, Inc. | 2001-07-09 |
| AMIGO WHEELCHAIR (K010503) | Amigo Mobility Intl., Inc. | 2001-07-06 |
| CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 (K011243) | Chattanooga Group, Inc. | 2001-07-06 |
| GLOBAL FX POROUS-COATED HUMERAL STEM (K011099) | DePuy Orthopaedics, Inc. | 2001-07-06 |
| PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE (K011787) | Vidamed, Inc. | 2001-07-06 |
| AUTO-DRIVE LAG SCREW SYSTEM (K010964) | Osteomed Corp. | 2001-07-05 |
| PREMIUM (K011130) | Heraeus Kulzer, Inc. | 2001-07-05 |
| MOBILE-PATIENT VIEWER (K011436) | Data Critical Corporation | 2001-07-05 |
| IN TEN-S (K011492) | Ivoclar North America, Inc. | 2001-07-05 |
| TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS (K003818) | Titan Implants | 2001-07-05 |
| TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 (K011731) | Medical Analysis Systems, Inc. | 2001-07-05 |
| BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY (K010668) | Bayer Corp. | 2001-07-05 |
| SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE (K011713) | Kimberly-Clark Corp. | 2001-07-05 |
| POWDERED LATEX EXAMINATION GLOVES (K011922) | Seltom Pacific Sdn. Bhd. | 2001-07-05 |
| SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE (K011170) | Synthes (Usa) | 2001-07-05 |
| STARBAND CRANIAL ORTHOSIS (K011350) | Orthomerica Products, Inc. | 2001-07-03 |
| SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC (K011141) | Shimadzu Corp. | 2001-07-03 |
| 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX (K011734) | Mogul Enterprises | 2001-07-03 |
| PRAIRIE CRUISER (K002580) | Raye'S, Inc. | 2001-07-03 |
| BIOZTECT SENSOR AND BIOZTECT CABLE (K011797) | Cardiodynamics International Corp. | 2001-07-03 |
| WATERLASE, MILLENNIUM (K011041) | Biolase Technology, Inc. | 2001-07-03 |
| SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA (K011032) | Harvest Technologies, Corp. | 2001-07-03 |
| HYALOMATRIX CO (K003855) | Fidia Advanced Biopolymers Srl | 2001-07-03 |
| BODYSTAT (K002835) | Bodystat , Ltd. | 2001-07-03 |
| SMART RAD (K003438) | Cmt Medical Technologies, Ltd. | 2001-07-03 |
| 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 (K011766) | St Jude Medical | 2001-07-03 |
| ETYMOTIC RESEARCH ER-10D OAE PROBE (K011114) | Etymotic Research | 2001-07-03 |
| PROVIEW EYE PRESSURE MONITOR (K011199) | Bausch & Lomb, Inc. | 2001-07-02 |
| RANDOX DIGOXIN (K011302) | Randox Laboratories, Ltd. | 2001-07-02 |
| PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE (K010599) | International Technidyne Corp. | 2001-07-02 |
| EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (K011920) | Syva Co., Dade Behring, Inc. | 2001-07-02 |
| 10% PVP; 10% PVP IN EBSS SOLUTION (K011481) | Conception Technologies | 2001-07-02 |
| TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS (K011171) | Procter & Gamble Co. | 2001-07-02 |
| I-STAT SYSTEM (K011478) | I-Stat Corp. | 2001-07-02 |
| PLUS CANCELLOUS BONE SCREWS (K011719) | Plus Orthopedics | 2001-07-02 |
| M2A ACETABULAR SYSTEM (K011110) | Biomet, Inc. | 2001-07-02 |
| RANDOX PHENOBARBITAL (K011303) | Randox Laboratories, Ltd. | 2001-07-02 |
| AGILENT M2636B TELEMON B MONITOR (TELEMON B) (K011824) | Agilent Technologies, Inc. | 2001-07-02 |
| EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (K011947) | Syva Co. | 2001-07-02 |
| HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM (K011573) | Conception Technologies | 2001-07-02 |
| CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) (K011740) | Meddev Corp. | 2001-07-02 |
| IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 (K011505) | Diagnostic Products Corp. | 2001-07-02 |
| ZURICH DISTRACTION SYSTEM (K010139) | KLS-Martin L.P. | 2001-06-29 |
| THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM (K010692) | Spintech, Inc. | 2001-06-29 |
| MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM (K011711) | Ebi, L.P. | 2001-06-29 |