| SHAPEABLE DOPPLER FLOW PROBE (K002958) | Cook Vascular, Inc. | 2001-12-18 |
| PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (K013451) | Phoenix Diagnostics, Inc. | 2001-12-18 |
| SPIRIT 300 (K013251) | Caire, Inc. | 2001-12-18 |
| MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (K014034) | Beckman Coulter, Inc. | 2001-12-18 |
| NO STEP ON SITE DEUG TEST CUP (K012390) | Drug Free Enterprises | 2001-12-18 |
| CRESCO TI IMPLANT CONCEPT (K981052) | Cresco TI Systems AB | 2001-12-18 |
| MODIFICATION TO ALPHA DX SYSTEM (K014024) | First Medical, Inc. | 2001-12-18 |
| INVERNESS MEDICAL EARLY PREGNANCY TEST (K013907) | Cambridge Diagnostics Ireland, Ltd. | 2001-12-18 |
| DATACAPTOR (K013019) | Capsule Technologie | 2001-12-18 |
| AURIS AEP (K012415) | Synapsys, Inc. | 2001-12-18 |
| RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (K013943) | Radi Medical Systems AB | 2001-12-18 |
| HOME-AWAY SYSTEM (K004047) | In-X Corp. | 2001-12-18 |
| STELLARTECH COAGULATION SYSTEM (K013139) | Stellartech Research Corp. | 2001-12-18 |
| SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K010925) | Siemens Elema AB | 2001-12-18 |
| DC-UIBC-CO2-CAL, MODEL SE-153 (K013178) | Diagnostic Chemicals , Ltd. | 2001-12-18 |
| ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE (K013380) | ACON Laboratories, Inc. | 2001-12-18 |
| SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM (K011907) | Sims Level 1, Inc. | 2001-12-18 |
| ADVIA CENTAUR HOMOCYSTEINE ASSAY (K013406) | Bayer Diagnostics Corp. | 2001-12-18 |
| RAMP MYOGLOBIN ASSAY (K012040) | Response Biomedical Corp. | 2001-12-18 |
| NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT (K012088) | Nastech Pharmaceutical Company, Inc. | 2001-12-18 |
| SELF-COUNTERSINKING BONE SCREW (K013534) | Biomet Orthopedics, Inc. | 2001-12-17 |
| TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K013317) | Tekmedic (M) Sdn Bhd | 2001-12-17 |
| HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 (K013903) | Triad Medical, Inc. | 2001-12-17 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (K011323) | Salimetrics, LLC | 2001-12-17 |
| SUMMIT CEMENTED HIP PROSTHESIS (K013352) | DePuy Orthopaedics, Inc. | 2001-12-17 |
| H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 (K013972) | Ackard Laboratories | 2001-12-17 |
| ACE BIO WIN TIBIAL NAILING SYSTEM (K013430) | DePuy Orthopaedics, Inc. | 2001-12-17 |
| POLESTAR N-10 (K010850) | Odin Medical Technologies , Ltd. | 2001-12-17 |
| OSSEOTITE DENTAL IMPLANTS (K013570) | Implant Innovations, Inc. | 2001-12-17 |
| DRG ORTHOHEX SS BONE SCREW (K013786) | Doctor'S Research Group, Inc. | 2001-12-17 |
| DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (K013302) | Allegiance Healthcare Corp. | 2001-12-17 |
| SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M (K013703) | Sanyo North America Corp. | 2001-12-14 |
| JOSTRA FLOWPROBE FP-32E (K013939) | Jostra AG | 2001-12-14 |
| SHOULDER COIL (K013541) | Usa Instruments, Inc. | 2001-12-14 |
| K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 (K013401) | K-Systems, Kivex Biotec , Ltd. | 2001-12-14 |
| MODIFICATION TO:APEX MEDICAL IF-4100 (K013813) | Apex Medical Corp. | 2001-12-14 |
| RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 (K013200) | Rennels Medical Corp. | 2001-12-14 |
| CTS-415 (K013327) | Shantou Institute of Ultrasonic Instuments | 2001-12-14 |
| NIPRO HYPODERMIC NEEDLE (K013293) | Nipro Medical Corp. | 2001-12-14 |
| ORTHOSONIX ENERGEX (K013094) | Orthosonix, Inc. | 2001-12-14 |
| ASMOTOM AUTOMATED TREPHINE SYSTEM (K013151) | Bkg Opthalmics USA, Inc. | 2001-12-14 |
| ETHANOL (K013538) | Abbott Laboratories | 2001-12-14 |
| DERMACLEAR UV-B PHOTOTHERAPY SYSTEM (K011197) | Lumenis | 2001-12-14 |
| GORE INTRODUCER SHEATH (K013282) | W. L. Gore & Associates, Inc. | 2001-12-14 |
| AIA-PACK CTNI 2ND-GEN ASSAY (K012820) | Tosoh Medics, Inc. | 2001-12-14 |
| CONVOY ADVANCED DELIVERY SHEATH KIT (K013866) | Boston Scientific | 2001-12-14 |
| ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS (K013935) | Sulzer Orthopedics, Inc. | 2001-12-13 |
| MODIFICATION TO THE GRIP (K010526) | Elcare Innovations, Inc. | 2001-12-13 |
| STRESS GUARD, MODEL HERDEV1 (K004008) | Herbo Medex International, Inc. | 2001-12-13 |
| IMMUNO-TROL LOW CELLS (K013842) | Beckman Coulter, Inc. | 2001-12-13 |
| 3D HUMERAL HEADS (K012378) | Smith & Nephew, Inc. | 2001-12-13 |
| ENDOFLIP (K013334) | Arthocare Corporation | 2001-12-13 |
| AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (K013242) | STERIS Corporation | 2001-12-13 |
| MODIFICATION TO EBI XFIX DFS SYSTEM (K013739) | Ebi, L.P. | 2001-12-13 |
| PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI (K013337) | Surgin, Inc. | 2001-12-13 |
| INVACARE ELEVATING SEAT OPTION ESS6 (K013516) | Invacare Corp. | 2001-12-13 |
| SOPRO 67D OPERATING ROOM CAMERA (K013090) | Sopro | 2001-12-13 |
| HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K013092) | Guidant Corp. | 2001-12-13 |
| DXS DIGITAL X-RAY SYSTEM (K013271) | Douglas C. Yoon, Dds | 2001-12-13 |
| DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM (K013358) | Pulse Metric, Inc. | 2001-12-13 |
| MEDRAD QWIK-FIT SYRINGE (K013815) | Medrad, Inc. | 2001-12-13 |
| CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH (K013367) | Reynolds Medical , Ltd. | 2001-12-13 |
| CRYSTAL 5000 PHASES ARRAY TMJ COIL (K013528) | Usa Instruments, Inc. | 2001-12-13 |
| ULTRASAFE DENTAL INJECTION SYSTEM (K013801) | Safety Syringes, Inc. | 2001-12-13 |
| INDIGO OPTIMA LASER SYSTEM (K013493) | Ethicon Endo-Surgery, Inc. | 2001-12-13 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY (K013992) | Nichols Institute Diagnostics | 2001-12-13 |
| WET LIGHT PERSONAL MOISTURIZER (K013086) | Trigg Laboratories, Inc. | 2001-12-13 |
| CAIRD TECHNOLOGY HOLTER 2000 (K012686) | Caird Technology | 2001-12-13 |
| SPINE SCOPE, MODEL 2180 (K011454) | Clarus Medical, LLC | 2001-12-13 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE (K013580) | Trek Diagnostic Systems, Inc. | 2001-12-12 |
| SAS STREPALERT (K013379) | Sa Scientific, Inc. | 2001-12-12 |
| BIOSPEED (K013069) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| MICROJET QUARK, MODEL U100 OR U40 (K013807) | Cane S.R.L. | 2001-12-12 |
| MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS (K013423) | Dade Microscan, Inc. | 2001-12-12 |
| JAMSHIDI BIOPSY NEEDLE (K013070) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| SECURCUT ASPIRATION BIOPSY NEEDLE (K013071) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR (K013076) | Beckman Coulter, Inc. | 2001-12-12 |
| SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP (K013767) | Sterling Medivations, Inc. | 2001-12-12 |
| PULPDENT CAVITY PREPARATION IV (K013411) | Pulpdent Corp. | 2001-12-12 |
| TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 (K013788) | Merits Health Products Co., Ltd. | 2001-12-11 |
| H.M.T. ACUPUNCTURE NEEDLE (K012501) | Hummingbird Medical Technology, LLC | 2001-12-11 |
| GRIP LOCK ANCHOR, MODEL 411374 (K013063) | Medtronic Neurological | 2001-12-11 |
| HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (K013066) | Olympus America, Inc. | 2001-12-11 |
| SURGICAL DYNAMICS MENISCAL STAPLE (K013890) | United States Surgical, A Division of Tyco Healthc | 2001-12-11 |
| INTERA I/T (K013344) | Philips Medical Systems North America Co. | 2001-12-11 |
| ACUGLIDE BRAND ACUPUNCTURE NEEDLES (K012583) | Helio Medical Supplies, Inc. | 2001-12-11 |
| MJS POSTERIOR STABILIZED KNEE SYSTEM (K012762) | Osteoimplant Technology, Inc. | 2001-12-11 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K013792) | Masimo Corp. | 2001-12-11 |
| DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 (K013246) | Datex-Ohmeda | 2001-12-11 |
| CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING (K010443) | Terumo Cardiovascular Systems Corp. | 2001-12-11 |
| KNIGHTSTAR 330 VENTILATOR (K003075) | Mallinckrodt, Inc. | 2001-12-11 |
| RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE (K012587) | Vidamed, Inc. | 2001-12-11 |
| SONDREX P.A.L. SYSTEM (K010388) | Ohmeda Medical | 2001-12-11 |
| OXOID PYLORI TEST KIT, MODEL DR0130M (K012588) | Oxoid , Ltd. | 2001-12-10 |
| REFERENCE CHECK, CATALOG NUMBER-RCN-10 (K013708) | Precision Biologic | 2001-12-10 |
| ICS MEDICAL MODEL VG-30 VIDEO GOGGLES (K013060) | Ics Medical | 2001-12-10 |
| SOCRATES ROBOTIC TELEMONITORING SYSTEM (K013804) | Computer Motion, Inc. | 2001-12-10 |
| ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM (K011244) | Zeus Scientific, Inc. | 2001-12-10 |
| THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM (K013050) | Bioplate, Inc. | 2001-12-10 |
| NURVO 9000 ENDOCAVITARY COILS (K011683) | Usa Instruments, Inc. | 2001-12-10 |