| PRECISA BIOPSY NEEDLE (K002944) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| ACTIS ADJUSTABLE CONSTRICTION LOOP (K003115) | Vivus, Inc. | 2000-12-19 |
| PLASMAKINETIC ENDOUROLOGY SYSTEM (K003569) | Gyrus Medical , Ltd. | 2000-12-19 |
| TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 (K993406) | Permobil AB | 2000-12-18 |
| ROCHE DIAGNOSTICS CK-MB (K003158) | Roche Diagnostics Corp. | 2000-12-18 |
| MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C (K003120) | Roche Diagnostics Corp. | 2000-12-18 |
| GRAMS NYLON NONABSORBABLE SUTURE (K003000) | Gramsmed, LLC | 2000-12-18 |
| VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME (K001927) | Thoratec Laboratories Corp. | 2000-12-18 |
| GRAMS POLYPROPYLENE NONABSORBABLE SUTURE (K002999) | Gramsmed, LLC | 2000-12-18 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K003622) | Agilent Technologies, Inc. | 2000-12-18 |
| MODIFICATION TO VNUS CLOSURE SYSTEM (K003092) | Vnus Medical Technologies, Inc. | 2000-12-18 |
| MEGAVISION CPX, MEGAVISION FA, MODEL I AND II (K002920) | Escalon Medical Corp. | 2000-12-18 |
| DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM (K002923) | Howmedica Osteonics Corp. | 2000-12-18 |
| MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER (K003721) | Olympus America, Inc. | 2000-12-18 |
| EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION (K002984) | Cybercare Technologies, Inc. | 2000-12-18 |
| SATURN BLOOD GLUCOSE MONITORING TEST STRIP (K001441) | Lifescan, Inc. | 2000-12-18 |
| TRANSFX ANGLED RODS (K003205) | Immedica, Inc. | 2000-12-15 |
| REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS (K002747) | Smith & Nephew, Inc. | 2000-12-15 |
| M2A 32MM TAPER SYSTEM (K003363) | Biomet, Inc. | 2000-12-15 |
| ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT (K003161) | Les Laboratoires Blanchard | 2000-12-15 |
| ALL TERRAIN WHEELCHAIR (ATW) (K003048) | Roll-Ability (Pty) , Ltd. | 2000-12-15 |
| BIRD TBIRD LEGACY VENTILATOR (K003770) | Bird Products Corp. | 2000-12-15 |
| ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 (K002906) | Ethicon Endo-Surgery, Inc. | 2000-12-15 |
| SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM (K002733) | Depuyacromed | 2000-12-15 |
| TITAN TIBIAL NAIL (K003018) | Howmedica Osteonics Corp. | 2000-12-15 |
| M-XX OXYGEN SENSORS (K002384) | International Business Strategies | 2000-12-15 |
| GRAMS SILK NONABSORBABLE SUTURE (K003001) | Gramsmed, LLC | 2000-12-15 |
| LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) (K003147) | Laserscope | 2000-12-15 |
| PROTRACT PRESS FIT HIP STEM (K003447) | Stelkast Company | 2000-12-15 |
| AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P (K003711) | Sein Electronics Co., Ltd. | 2000-12-15 |
| HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING (K003211) | Howmedica Osteonics Corp. | 2000-12-15 |
| MEROGEL CONTROL GEL ENT SURGICAL DRESSING (K002972) | Medtronic Xomed | 2000-12-15 |
| RYTHMIC AND RYTHMIC UV (K003170) | Essilor Intl. | 2000-12-15 |
| AIW WATER SYSTEM FOR HEMODIALYSIS (K001282) | American Industrial Water | 2000-12-15 |
| QUICKIE 2 POWER ASSIST WHEELCHAIR (K001491) | Sunrise Medical, Inc. | 2000-12-15 |
| MTG - MINITUB HEATED STAGE SYSTEMS (K002971) | Zander Medical Supplies, Inc. | 2000-12-15 |
| SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD (K003015) | Surgical Specialties Corp | 2000-12-15 |
| ACE AIM TTC FUSION NAIL (K003797) | DePuy Orthopaedics, Inc. | 2000-12-15 |
| AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A (K003038) | Agilent Technologies Deutschland GmbH | 2000-12-15 |
| VIVANT BREAST LESION LOCALIZATION DEVICE (K003439) | Vivant Medical, Inc. | 2000-12-15 |
| X-POSURE SYSTEM VERSION 2 MAMMO (K003656) | Pronosco A/S | 2000-12-15 |
| ELECSYS HCG AND BETA TEST SYSTEM (K003178) | Roche Diagnostics Corp. | 2000-12-14 |
| CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO (K000834) | Castellini S.P.A. | 2000-12-14 |
| CREATININE (K003247) | Jas Diagnostics, Inc. | 2000-12-14 |
| K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A (K003228) | Katecho, Inc. | 2000-12-14 |
| METALYZER, MODEL 2; METALYZER, MODEL 3 (K993641) | Cortex Biophysik GmbH | 2000-12-14 |
| VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER (K994337) | Orthovita Co. | 2000-12-14 |
| BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT (K002506) | Sims Portex, Inc. | 2000-12-14 |
| PROCLUDE (K002989) | Ortek Therapeutics, Inc. | 2000-12-14 |
| COPELAND RESURFACING HEADS (K003044) | Biomet, Inc. | 2000-12-13 |
| ECAT PET SCANNER (K003241) | Cti Pet Systems, Inc. | 2000-12-13 |
| GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K003071) | Ciba Vision Corporation | 2000-12-13 |
| DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K003523) | DePuy Orthopaedics, Inc. | 2000-12-13 |
| NEXAN SYSTEM, MODEL NX-300 (K003520) | Nexan, Ltd. | 2000-12-13 |
| OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 (K003056) | Labotect Labor-Technik Gottingen | 2000-12-13 |
| ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS (K002985) | Ics Medical Corp. | 2000-12-13 |
| GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC (K003195) | Greer Laboratories, Inc. | 2000-12-13 |
| SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) (K003283) | Sterling Medivations, Inc. | 2000-12-13 |
| PAIN CARE MULTI-PORT CATHETER, MODEL 2000L (K003611) | Breg, Inc. | 2000-12-13 |
| ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S (K001233) | R-Group Intl. | 2000-12-13 |
| MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL (K003144) | Medical Advances, Inc. | 2000-12-13 |
| ORTHOMATRIX, INC. CERCLAGE SYSTEM (K001254) | Orthomatrix, Inc. | 2000-12-13 |
| HARDY DISK, CEFPODOXINE, 10MCG (K003532) | Hardy Diagnostics | 2000-12-13 |
| PRO-FEMUR R (K003016) | Wrightmedicaltechnologyinc | 2000-12-13 |
| CALEO (K003067) | Drager Medizintechnik GmbH | 2000-12-13 |
| COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP (K003616) | Baxter Healthcare Corp | 2000-12-12 |
| SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 (K002970) | Medical Designs, LLC | 2000-12-12 |
| OPUS 20, MODEL 1ST (K002899) | Opusdent , Ltd. | 2000-12-12 |
| PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228 (K003249) | Pst, Inc. | 2000-12-12 |
| LEIBINGER NEURO CLIP SYSTEM (K003660) | Stryker Instruments | 2000-12-12 |
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K003201) | Medtronic Surgical Navigation Technologies | 2000-12-12 |
| SHENLING ACUPUNCTURE NEEDLES (K002411) | Shenling Medical Device Co., Ltd. | 2000-12-12 |
| GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES (K002569) | Malgam Ent., Inc. | 2000-12-12 |
| MERIT DRAINAGE DEPOT (K003078) | Merit Medical Systems, Inc. | 2000-12-11 |
| TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 (K002960) | Zimmer, Inc. | 2000-12-11 |
| EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP (K994146) | Plus Orthopedics | 2000-12-11 |
| EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR (K001550) | Imatron, Inc. | 2000-12-11 |
| TRIDENT ALL POLY CUP (K001956) | Howmedica Osteonics Corp. | 2000-12-11 |
| PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR (K000851) | Psychemedics Corp. | 2000-12-11 |
| MODEL 30 CLASSIC PNEUMATONOMETER (K002395) | Xomed, Inc. | 2000-12-11 |
| MILLENNIUM BLADES, MODEL MB101 (K003143) | Millennium Biomedical, Inc. | 2000-12-11 |
| ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS (K002616) | Electric Mobility, LLC | 2000-12-11 |
| SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 (K000249) | Schaefer Water Centers | 2000-12-11 |
| SYNERGY HA COATED POROUS FEMORAL STEMS (K002996) | Smith & Nephew, Inc. | 2000-12-11 |
| VERSABOND BONE CEMENT (K001160) | Smith & Nephew, Inc. | 2000-12-11 |
| SNARE,FLEXIBLE (K002927) | Odon Lifetechnology | 2000-12-10 |
| HANGER CRANIAL BAND (K001669) | Hanger Orthopedic Group, Inc. | 2000-12-08 |
| TISSUELINK BIPOLAR FORCEPS (K003005) | Tissuelink Medical, Inc. | 2000-12-08 |
| OPUS ROD FIXATION SYSTEM (K003490) | Howmedica Osteonics Corp. | 2000-12-08 |
| NOVOFINE 31 DISPOSABLE NEEDLE (K002403) | Novo Norodisk Pharmaceuticals, Inc. | 2000-12-08 |
| NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP (K003674) | Davol Inc., Sub. C. R. Bard, Inc. | 2000-12-08 |
| LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (K000594) | Stryker Leibinger | 2000-12-08 |
| STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 (K003002) | Steritec Products, Inc. | 2000-12-08 |
| MAGELLAN VENTILATOR (K002951) | Oceanic Medical Products, Inc. | 2000-12-08 |
| COOL-TEC ELECTRODES (K002841) | Seedling Enterprises., LLC | 2000-12-08 |
| SW ULTRASOUND, MODELS 331, 311, 333 (K991613) | Starbene | 2000-12-08 |
| VASCULAR CLOSURE DEVICE (K003169) | Std Mfg., Inc. | 2000-12-08 |
| COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE (K002691) | Com-Med International, Inc. | 2000-12-08 |
| PAFLUFOCON C AND E DAILY CONTACT LENS (K002845) | Paragon Vision Sciences | 2000-12-08 |
| THERMAGE THERMACOOL II SYSTEM (K003183) | Thermage, Inc. | 2000-12-08 |