| QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION (K010039) | Chronimed, Inc. | 2001-08-10 |
| ROSS EMBRACE PUMP SET (K011467) | Ross Products | 2001-08-10 |
| CHASE CARDIOVASCULAR PATCH (K012248) | Chase Medical, Inc. | 2001-08-10 |
| CYBERKNIFE SYSTEM (K011024) | Accuray, Inc. | 2001-08-10 |
| VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE (K010544) | Apex Dental Materials, Inc. | 2001-08-10 |
| GENZYME DIRECT-AMYLASE TEST REAGENT (K011843) | Genzyme Corp. | 2001-08-10 |
| KOALA CLAMP, KOALA CLAMP AND CUTTER (K011621) | Maternus, Inc. | 2001-08-10 |
| POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID (K011472) | Medtronic Functional Diagnostics A/S | 2001-08-10 |
| OLYMPUS SPRAY CATHETER PW-6C-1 (K012073) | The Olympus Optical Co. | 2001-08-10 |
| HISPEED X/I SMART GANTRY OPTION (K012385) | Ge Medical Systems, Inc. | 2001-08-10 |
| REUSABLE GLASS SYRINGES (K011176) | Lockett Medical Corp. | 2001-08-10 |
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM (K012389) | Ge Medical Systems, Inc. | 2001-08-10 |
| CERVILENZ UTERINE MEASURING SOUND (K011840) | Cervilenz, Inc. | 2001-08-10 |
| KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS (K012155) | Eastman Kodak Company | 2001-08-10 |
| IMAGE-X SYSTEM (K012355) | Tg Group, Inc. | 2001-08-09 |
| XUB EXTERNAL ULTRASOUND (K010702) | Kmi Kolster Methods, Inc. | 2001-08-09 |
| GIBBONS STERILE TROCAR KITS (K012198) | Gibbons Surgical Corp. | 2001-08-09 |
| ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM (K011320) | Hitachi Medical Systems America, Inc. | 2001-08-09 |
| ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (K011962) | Advantage Diagnostics Corp. | 2001-08-09 |
| MUSCLE STIMULATOR SA-100 (K010807) | Health@Fitness Technologies, Inc. | 2001-08-09 |
| MODIFICATION TO ACCU-CHEK INFORM METER (K012210) | Roche Diagnostics Corp. | 2001-08-09 |
| INTRALASE 600C LASER KERATOME (K002890) | Intra Lase Corp. | 2001-08-09 |
| ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM (K011538) | Ethicon Endo-Surgery, Inc. | 2001-08-09 |
| TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE (K011571) | The RX Files Corp. | 2001-08-09 |
| BCT SYSTEM (K011665) | Dade Behring, Inc. | 2001-08-09 |
| OSSTELL RESONANCE FREQUENCY ANALYZER (K003714) | Integration Diagnostics, Ltd. | 2001-08-09 |
| ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE (K011730) | ACON Laboratories, Inc. | 2001-08-09 |
| SYNTHES LCP PROXIMAL TIBIA PLATE (K011978) | Synthes (Usa) | 2001-08-09 |
| LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (K012373) | Ferrania S.P.A. | 2001-08-09 |
| ANSPACH EMAX DRILL SYSTEM (K011444) | The Anspach Effort, Inc. | 2001-08-08 |
| FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 (K012054) | Sein Electronics Co., Ltd. | 2001-08-08 |
| REJUVENIQUE MODEL #RJV10 (K011935) | Salton, Inc. | 2001-08-08 |
| MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION (K012286) | Roche Diagnostics Corp. | 2001-08-08 |
| MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION (K012287) | Roche Diagnostics Corp. | 2001-08-07 |
| CT COLONOGRAPHY/NAVIGATOR2 (K012313) | Ge Medical Systems, Inc. | 2001-08-07 |
| LACTOSORB RAPIDFLAP (K003281) | Biomet, Inc. | 2001-08-07 |
| INPULSE DENTAL LASER (K011423) | Incisive, LLC | 2001-08-07 |
| COLLAGEN DENTAL MEMBRANE (K011695) | Collagen Matrix, Inc. | 2001-08-07 |
| PIT AND FISSURE CHEMICAL CURING SEALANT (K011822) | Rite-Dent Manufacturing Corp. | 2001-08-07 |
| SCS CLARIS SPINAL SCREWS, TYPES V,G,E (K011807) | Ortho Tec, LLC | 2001-08-07 |
| WUJIN #3 FEMORAL BONE PLATE (K011459) | Biopro, Inc. | 2001-08-07 |
| PRAXSYS RELIA TSH TEST (K011527) | Praxsys Biosystems, Inc. | 2001-08-07 |
| QUIK-CHECK HOME PREGNANCY TEST (K012215) | ACON Laboratories, Inc. | 2001-08-07 |
| WUJIN #3 TIBIAL BONE PLATE (K011460) | Biopro, Inc. | 2001-08-07 |
| GC E-LIGHT (K012134) | GC America, Inc. | 2001-08-07 |
| MUSCLE IMAGING SYSTEM (MIS) (K011416) | Millennium Magnetic Imaging, Inc. | 2001-08-06 |
| STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (K012282) | Cypress Medical Products, Ltd. | 2001-08-06 |
| DISPO ETCH (K984380) | Kis Products | 2001-08-06 |
| CONDUCTIVE GEL FOR ULTRASOUND (K002832) | Skylark Device & Systems Co., Ltd. | 2001-08-06 |
| DISPOPROPHY (K993182) | Kis Products | 2001-08-06 |
| CROSS-CHECKS DUAL, MODEL CI 125 (K010534) | Steritec Products, Inc. | 2001-08-06 |
| FLEXICAST PRIME (K011706) | American Dent-All, Inc. | 2001-08-06 |
| CHILLIT (K011666) | Heatshield, Inc. | 2001-08-06 |
| DISPODRILL (K993124) | Kis Products | 2001-08-06 |
| SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 (K981693) | Gebauer Co. | 2001-08-06 |
| ADD-ON CONDYLE (K002790) | Walter Lorenz Surgical, Inc. | 2001-08-06 |
| TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 (K011751) | Merits Health Products., Inc. | 2001-08-06 |
| ADVANCED HIP ASSESSMENT SOFTWARE (K011917) | Ge Lunar Corp. | 2001-08-03 |
| VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT (K011031) | Vysis | 2001-08-03 |
| MICROSTIM 100I TENS DEVICE (K010295) | Microstim, Inc. | 2001-08-03 |
| NIDOIL (K012123) | Nidacon International AB | 2001-08-03 |
| THREADED CEMENT RESTRICTOR (CR) TITANIUM (K011443) | Medtronic Sofamor Danek USA, Inc. | 2001-08-03 |
| THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 (K011768) | Thermo-Electric Co. | 2001-08-03 |
| NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 (K011971) | Image-Guided Neurologics, Inc. | 2001-08-03 |
| FIRST FILL R.C.S. (K011748) | Jeneric/Pentron, Inc. | 2001-08-03 |
| EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE (K011386) | Ebi, L.P. | 2001-08-03 |
| TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 (K011753) | Merits Health Products., Inc. | 2001-08-03 |
| MP-3C POWER BASE CHAIR, MODEL MP3C (K011687) | Merits Health Products., Inc. | 2001-08-03 |
| SUPREMCAST (K011705) | American Dent-All, Inc. | 2001-08-03 |
| EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (K012257) | Syva Co. | 2001-08-03 |
| PERSYST REVEAL (K011397) | Persyst Development Corp. | 2001-08-03 |
| GEO STRUCTURE (K010530) | Interpore Cross Intl. | 2001-08-03 |
| WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S (K012068) | Sims Portex , Ltd. | 2001-08-03 |
| 1.5T INFINITY TWINSPEED MR SYSTEM (K012200) | GE Medical Systems | 2001-08-03 |
| SOLARA JR. MANUAL WHEELCHAIR (K012370) | Invacare Corp. | 2001-08-03 |
| IN SPACE 3D (K011447) | Siemens Medical Solutions USA, Inc. | 2001-08-03 |
| TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 (K011707) | Merits Medical Industries Co., Ltd. | 2001-08-03 |
| KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS (K010345) | KARL STORZ Endoscopy-America, Inc. | 2001-08-03 |
| ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM (K011102) | Aesculap, Inc. | 2001-08-03 |
| XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 (K011382) | Photo Medex, Inc. | 2001-08-02 |
| CADENCE PRECISION INJECTOR, MODEL 103-0304 (K011535) | Micro Therapeutics, Inc. | 2001-08-02 |
| EZ SYRINGE (K011951) | Owen Mumford, Ltd. | 2001-08-02 |
| DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS (K011368) | Gambro Renal Products | 2001-08-02 |
| SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM (K011458) | Synthes (Usa) | 2001-08-02 |
| SOMNO STAR & SERIES SLEEP SYSTEM (K012085) | Sensor Medics Corp. | 2001-08-02 |
| MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI (K010413) | Konica Minolta Sensing, Inc. | 2001-08-02 |
| M5T INSTANT FEVER THERMOMETER (K012217) | Medisim, Ltd. | 2001-08-01 |
| POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012135) | Wrp Asia Pacific Sdn. Bhd. | 2001-08-01 |
| CENTRAL VENOUS CATHETER (K003839) | Boston Scientific Corp | 2001-08-01 |
| SPARC SLING SYSTEM (K011251) | American Medical Systems, Inc. | 2001-08-01 |
| MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION (K010300) | Medtronic Vascular | 2001-08-01 |
| THE ALBERTA LENS SM2, SULFOCON B (K010454) | Progressive Optical Research , Ltd. | 2001-08-01 |
| POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR (K011791) | Latexx Partners Bhd. | 2001-08-01 |
| TRS-2000 POWER TILT/POWER RECLINE SYSTEM (K012281) | Accelerated Rehab Designs, Inc. | 2001-08-01 |
| MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT (K012069) | Neurotron Medical, Inc. | 2001-08-01 |
| CANNULATED PLUS SCREW SYSTEM (K010738) | Orthomatrix, Inc. | 2001-08-01 |
| MODIFICATION TO: LONG LENGTH GAMMA NAIL (K012158) | Howmedica Osteonics Corp. | 2001-08-01 |
| WAKO IMMUNOASSAY CALIBRATOR SET (K010332) | Wako Chemicals USA, Inc. | 2001-08-01 |
| MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM (K012299) | Basic Dental Implant Systems, Inc. | 2001-08-01 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K012090) | Cordis, A Johnson & Johnson Co. | 2001-08-01 |