| MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT (K011761) | Arrow Intl., Inc. | 2001-10-31 |
| PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET (K011221) | Gambro Renal Products | 2001-10-31 |
| MODIFICATION TO: ECAT LSO PET/CT SCANNER (K013504) | Cti Pet Systems, Inc. | 2001-10-31 |
| OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS (K012495) | Siemens Medical Solutions USA, Inc. | 2001-10-31 |
| CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 (K012497) | Galil Medical , Ltd. | 2001-10-30 |
| CARDIQ FUNCTION (K013422) | GE Medical Systems | 2001-10-30 |
| PALAMED BONE CEMENT (K010586) | Merck Biomaterial GmbH | 2001-10-30 |
| SEPRAGEL SINUS (K012532) | Genzyme Corp. | 2001-10-30 |
| SOVEREIGN (K011476) | Shoprider Intl., Inc. | 2001-10-30 |
| HEMI-ARC SURGICAL NAVIGATOR (K013257) | Nuvasive, Inc. | 2001-10-30 |
| VANGUARD REPROCESSED ARTHROSCOPIC WANDS (K012695) | Vanguard Medical Concepts, Inc. | 2001-10-30 |
| LIFEJET VIDEO LINK (K013395) | Ferrania S.P.A. | 2001-10-30 |
| TM2000 EASYTRACE PLUS RECEIVING CENTER (K013175) | Card Guard Scientific Survival , Ltd. | 2001-10-30 |
| ULTRASOUND TRANSDUCER COVER (K011265) | Advance Medical Designs, Inc. | 2001-10-30 |
| HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (K012895) | Trek Diagnostic Systems, Inc. | 2001-10-30 |
| CRANIAL HELMET (K013458) | Children'S Hospital | 2001-10-29 |
| BELLEGLASS HP OPAQUE 2 (K013375) | Kerr Dental Materials Center | 2001-10-29 |
| XANTALGIN CRONO (K013336) | Cavex Holland BV | 2001-10-29 |
| MICROMEDICS FIBRIJET AEROSOL APPLICATOR (K012868) | Micromedics, Inc. | 2001-10-29 |
| CW DISPOSABLE ACUPUNCTURE NEEDLE (K011248) | Acusupply, Inc. | 2001-10-29 |
| MICROPLEX COIL SYSTEM (K012145) | MicroVention, Inc. | 2001-10-29 |
| MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR (K012465) | Bonutti Research, Inc. | 2001-10-29 |
| APEX MEDICAL LCD TENS-VII (K012643) | Apex Medical Corp. | 2001-10-29 |
| THEKEN LARGE CEMENT RESTRICTOR (K012462) | Theken Surgical,Llc | 2001-10-29 |
| FUJI VII CAPSULE (K013198) | GC America, Inc. | 2001-10-29 |
| MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 (K013348) | Erbe USA, Inc. | 2001-10-26 |
| GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM (K012628) | Gynecare Center | 2001-10-26 |
| STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE (K001509) | Cobe Cardiovascular, Inc. | 2001-10-26 |
| DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (K012449) | Diamedix Corp. | 2001-10-26 |
| OSTEOSET BVF KIT (K010532) | Wrightmedicaltechnologyinc | 2001-10-26 |
| AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A (K010729) | Andromed, Inc. | 2001-10-26 |
| BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 (K012636) | Vsm Technology, Inc. | 2001-10-26 |
| SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES (K011913) | Sun-Rain System Corp. | 2001-10-26 |
| SPARC SLING SYSTEM (K013355) | American Medical Systems, Inc. | 2001-10-26 |
| TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (K012632) | Medical Instruments Technology, Inc. | 2001-10-26 |
| DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (K012450) | Diamedix Corp. | 2001-10-26 |
| INFINITY HBA KIT, MODELS 537-A, 537-B (K012410) | Sigma Diagnostics, Inc. | 2001-10-26 |
| CONFOSCAN 2 CONFOCAL MICROSCOPE (K012416) | Nidek Technologies Srl | 2001-10-26 |
| GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT (K013250) | W. L. Gore & Associates, Inc. | 2001-10-26 |
| SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 (K012809) | Power Medical Interventions, Inc. | 2001-10-26 |
| BIOPATCH ANTIMICROBIAL DRESSING (K003229) | Integra Lifesciences Corp. | 2001-10-26 |
| ADVANCED LUNG ANALYSIS-1 (K013381) | General Electric Co. | 2001-10-26 |
| VITALSAT PULSE OXIMETER, MODEL IC32000 (K011365) | Island Critical Care Corp. | 2001-10-26 |
| NU-SPEC D (K012859) | Sol Weiss MD, Inc. | 2001-10-26 |
| OXYGENATOR (K002632) | Adjunctive Therapeutics, Inc. | 2001-10-25 |
| VENODYNE DVT ADVANTAGE PLUS (K011318) | Microtek Medical, Inc. | 2001-10-25 |
| MONOJECT SAFETY NEEDLE (K012736) | Tyco Healthcare | 2001-10-25 |
| WINNER CM4 COMBINATION UNIT (K012848) | Rich-Mar Corp. | 2001-10-25 |
| AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE (K012141) | External Counterpulsation Lab | 2001-10-25 |
| ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY (K013272) | Bayer Corp. | 2001-10-25 |
| AUTOPULSE, MODEL 100 (K011046) | Revivant Corp. | 2001-10-25 |
| DRUGS OF ABUSE MULTI-TEST STRIP (K011952) | Microdiagnostics, Inc. | 2001-10-25 |
| COLLATEK SHEET (K012995) | Biocore Medical Technologies, Inc. | 2001-10-25 |
| ARTHROCARE ELECTROSURGERY WANDS (K012519) | Arthrocare Corp. | 2001-10-25 |
| LIFE 2 (K012717) | Sybron Dental Specialties, Inc. | 2001-10-25 |
| CERCON BASE (K013230) | Degussa - Ney Dental, Inc. | 2001-10-25 |
| MACROPORE ENT RECONSTRUCTION FILM (K012769) | Macropore Biosurgery, Inc. | 2001-10-25 |
| COLLATEK FOAM (K012997) | Biocore Medical Technologies, Inc. | 2001-10-25 |
| EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 (K000741) | 138 Medical Supplies, Inc. | 2001-10-24 |
| C.T.M. MOBITIY SCOOTER MODEL #HS-360 (K012792) | Warepalmy Enterprise, LLC (Usa) | 2001-10-24 |
| EZ-ON CONDOM (K001974) | Mayer Laboratories | 2001-10-24 |
| PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM (K012673) | Prime Dental Manufacturing, Inc. | 2001-10-24 |
| MODIFIED 650 MAMMOGRAPHY SYSTEM (K013290) | Lorad, A Hologic Co. | 2001-10-24 |
| 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 (K012143) | Medtronic Cardiac Surgical Products | 2001-10-24 |
| MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX (K012822) | Boston Scientific Scimed, Inc. | 2001-10-24 |
| CAAS II QVA (K012475) | Pie Medical Imaging BV | 2001-10-24 |
| MACHNET CAROTIDS COIL ARRAY ASSEMBLY (K012491) | Machnet BV | 2001-10-24 |
| ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD (K011056) | Arrow Intl., Inc. | 2001-10-24 |
| LIFT VB SPINAL SYSTEM (K010930) | Medtronic Sofamor Danek, Inc. | 2001-10-24 |
| PASS SPINAL SYSTEM (K013191) | Encore Orthopedics, Inc. | 2001-10-24 |
| COLLATEK POWDER (K012990) | Biocore Medical Technologies, Inc. | 2001-10-24 |
| C.T.M. MOBILITY SCOOTER MODEL # HS-320 (K012791) | Warepalmy Enterprise, LLC (Usa) | 2001-10-24 |
| COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 (K012832) | Nxstage Medical, Inc. | 2001-10-24 |
| SECUREGUARD RETRACTABLE SAFETY SYRINGE (K012121) | Safegard Medical Products, Inc. | 2001-10-24 |
| INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 (K012864) | Boston Scientific Corp | 2001-10-24 |
| GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE (K013147) | Bionostics, Inc. | 2001-10-24 |
| CONFORM SHEETING, MODEL IGEL (K012419) | Implantech Associates, Inc. | 2001-10-24 |
| XTERRA GT POWER WHEELCHAIR (K012909) | Invacare Corp. | 2001-10-24 |
| ERO50, ORDER-NO.: 2070 (K012838) | Wieland Edelmetalle GmbH & Co. | 2001-10-23 |
| POINT 4 FLOWABLE 2 (K013325) | Kerr Dental Materials Center | 2001-10-23 |
| EURO 45, ORDER-NO.: 2064 (K012840) | Wieland Edelmetalle GmbH & Co. | 2001-10-23 |
| MODIFICATION TO: HL168W TOUCH SCREEN (K013033) | Health & Life Co., Ltd. | 2001-10-23 |
| MODIFICATION TO BRAIDED GUIDING INTRODUCER (K013202) | Thomas Medical Products, Inc. | 2001-10-23 |
| HUMI-FLOW, MODEL 6-850-00/ 01/02 (K010053) | Northgate Technologies, Inc. | 2001-10-23 |
| TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII (K011058) | Meridian Medical Technologies , Ltd. | 2001-10-23 |
| AMEDITECH IMMUTEST DRUG SCREEN THC (K011813) | Ameditech, Inc. | 2001-10-22 |
| STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) (K013059) | Stony Brook Surgical Innovations, Inc. | 2001-10-22 |
| ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS (K012777) | Bayer Corp. | 2001-10-22 |
| ASTRALIS 7, MODEL 557545 (K013277) | Ivoclar Vivadent, Inc. | 2001-10-22 |
| CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM (K011502) | Crystal-Seal Dental Implants | 2001-10-22 |
| COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER (K012955) | Bioform, Inc. | 2001-10-22 |
| AMEDITECH IMMUTEST DRUG SCREEN COC (K011814) | Ameditech, Inc. | 2001-10-22 |
| MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER (K011392) | Micra Instruments | 2001-10-22 |
| SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) (K012457) | Sodemsystems | 2001-10-22 |
| D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (K012821) | Dutch Ophthalmic USA, Inc. | 2001-10-22 |
| SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) (K012453) | Sodemsystems | 2001-10-22 |
| STATUSBLUE (K013237) | Dmg USA, Inc. | 2001-10-22 |
| METAL SCREW ANCHOR (K012503) | Biomet Manufacturing, Inc. | 2001-10-22 |
| REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS (K012625) | Alliance Medical Corp. | 2001-10-22 |
| ICE (K012528) | Southern Dental Industries, Ltd. | 2001-10-22 |