| HERMES PORT EXPANDER (K003217) | Computer Motion, Inc. | 2000-11-03 |
| 3D ENDOSCOPE (K002924) | KARL STORZ Endoscopy-America, Inc. | 2000-11-03 |
| PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE (K003019) | Wrp Asia Pacific Sdn. Bhd. | 2000-11-03 |
| MERIDIAN-II AND MERDIAN-PLUS (K001347) | Meridian Co., Ltd. | 2000-11-03 |
| RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE (K003233) | Riverstone Resources Sdn Bhd | 2000-11-03 |
| ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 (K001788) | Erecords Enterprises | 2000-11-03 |
| CANDELA MID IR DIODE LASER SYSTEM (K002421) | Candela Corp. | 2000-11-03 |
| MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (K001714) | Mercury Medical | 2000-11-03 |
| PILLING E-FRAZIER BIPOLAR SUCTION TUBE (K002582) | Pilling | 2000-11-03 |
| KSEA MINIATURE NEUROENDOSCOPE (K002704) | KARL STORZ Endoscopy-America, Inc. | 2000-11-03 |
| NOVALIS (SHAPED BEAM SURGERY SYSTEM) (K002509) | Brainlab AG | 2000-11-03 |
| ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING (K002398) | Ethicon Endo-Surgery, Inc. | 2000-11-03 |
| CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 (K001213) | Hudson Respiratory Care, Inc. | 2000-11-03 |
| QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 (K001249) | Consolidated Technologies of Wisconsin | 2000-11-02 |
| MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT (K003131) | Biomet, Inc. | 2000-11-02 |
| SIMPLICITY SPINAL SYSTEM (K002103) | Medtronic Sofamor Danek USA, Inc. | 2000-11-02 |
| OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A (K001676) | Trimedyne, Inc. | 2000-11-02 |
| HARDYDISK CLINDAMYCIN, 2MCG (K002662) | Hardy Diagnostics | 2000-11-02 |
| VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V (K002392) | Integra Neurocare, LLC | 2000-11-02 |
| QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H (K002390) | Lsi Intl., Inc. | 2000-11-02 |
| RETINADX (K003236) | Regulatory Associates, Inc. | 2000-11-02 |
| ACCUWELL TSH, MODEL KAW-TSH-960 (K001455) | Neometrics, Inc. | 2000-11-02 |
| R&D PROJECT DW271#11A (K002872) | Ivoclar North America, Inc. | 2000-11-02 |
| MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 (K002456) | Becton Dickinson Vacutainer Systems | 2000-11-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K003112) | Ortho-Clinical Diagnostics, Inc. | 2000-11-02 |
| SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) (K002362) | Synthes (Usa) | 2000-11-01 |
| NUMED TYSHAK AND Z-MED PTV CATHETERS (K003114) | NuMED, Inc. | 2000-11-01 |
| MEDOVATIONS ESOPHAGEAL DILATOR (K002363) | Medovations, Inc. | 2000-11-01 |
| AB-180 XC SYSTEM, MODEL AB-180XC (K991783) | Cardiacassist, Inc. | 2000-11-01 |
| ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT (K002374) | Straumann USA | 2000-11-01 |
| FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H (K003282) | Sein Electronics Co., Ltd. | 2000-11-01 |
| NUMED TYSHAK II AND Z-MED II PTV CATHETERS (K003052) | NuMED, Inc. | 2000-11-01 |
| CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM (K001948) | Hypertension Diagnostics, Inc. | 2000-11-01 |
| CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER (K002590) | Cedara Software Corp. | 2000-10-31 |
| PLASMAKINETIC GENERATOR (K003060) | Everest Medical Corp. | 2000-10-31 |
| ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (K002811) | Nordiska Dental AB | 2000-10-31 |
| RIGID GAS PERMEABLE CONTACT LENS (K002025) | Polymer Technology | 2000-10-31 |
| SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM (K002361) | Synthes (Usa) | 2000-10-31 |
| CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE (K002546) | CIVCO Medical Instruments Co., Inc. | 2000-10-31 |
| ECAT PET SCANNER (K002715) | Cti Pet Systems, Inc. | 2000-10-31 |
| ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (K002810) | Nordiska Dental AB | 2000-10-31 |
| ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (K002808) | Nordiska Dental AB | 2000-10-31 |
| SMITH & NEPHEW PISTONS (K003214) | Gyrus Ent LLC | 2000-10-31 |
| SIGNA MFO/I MAGNETIC RESONANCE SYSTEM (K002611) | GE Medical Systems | 2000-10-31 |
| SEEDNET, MODEL EP6T5, EP5E5 (K003065) | Galil Medical , Ltd. | 2000-10-31 |
| CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 (K002556) | Pharmacia & Upjohn Co. | 2000-10-31 |
| PBN FALLOPIAN TUBE CATHETER SYSTEM (K000620) | Medical Device Technologies, Inc. | 2000-10-30 |
| SYNTHES USS (10.0MM SIDE OPENING SCREWS) (K003061) | Synthes | 2000-10-30 |
| CORDIS SLALOM PTA BALLOON CATHETER (K003159) | Cordis Corp. | 2000-10-30 |
| WUJIN #3 TIBIAL NAIL (K002325) | Biologically Oriented Prostheses | 2000-10-30 |
| CRANIOCAP (K000861) | Gillette Children'S Specialty Healthcare | 2000-10-30 |
| SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, (K002188) | Core-Vent Corp. | 2000-10-30 |
| NIR BILIARY STENT (K002130) | Medinol, Ltd. | 2000-10-30 |
| RESPONDER 3000 (K000638) | Ge Medical Systems Information Technologies GmbH | 2000-10-30 |
| NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS (K002356) | Sulzer Orthopedics, Inc. | 2000-10-30 |
| KSEA VASCULAR FIBERSCOPES (K001408) | KARL STORZ Endoscopy-America, Inc. | 2000-10-30 |
| ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER (K002676) | Guidant Cardiac and Vascular Surgery | 2000-10-30 |
| SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM (K000317) | Tissue Medical Lasers, Inc. | 2000-10-27 |
| 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A (K002424) | Toshiba America Medical Systems, In.C | 2000-10-27 |
| ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK (K001972) | Visicu, Inc. | 2000-10-27 |
| MITEK CUFFTACK (K003076) | Mitek Products | 2000-10-27 |
| SUPER NOVA, ACUBEAM (K001179) | Light Force Therapy, Inc. | 2000-10-27 |
| TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION (K003006) | Arrow Intl., Inc. | 2000-10-27 |
| HARDYDISK GENTAMICIN, 120MCG (K002369) | Hardy Diagnostics | 2000-10-26 |
| 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC (K002880) | Pie Medical | 2000-10-26 |
| HARDYDISK LEVOFLOXACIN, 5MCG (K002664) | Hardy Diagnostics | 2000-10-26 |
| RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) (K003232) | Riverstone Resources Sdn Bhd | 2000-10-26 |
| SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002563) | The Binding Site, Ltd. | 2000-10-26 |
| LITEAIRE (K993101) | Thayer Medical Corp. | 2000-10-26 |
| HARDY DISK CEFTIZOXIME, 30MCG (K002367) | Hardy Diagnostics | 2000-10-26 |
| ABX MICROS CRP (K002646) | Abx Diagnostics | 2000-10-26 |
| GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (K994390) | Gambro Healthcare | 2000-10-26 |
| PHOENIX DIGITAL EEG (K002316) | Axon Systems, Inc. | 2000-10-26 |
| NEUROTOLOGY DRAPE, MODEL TBD (K002702) | Gyrus Ent LLC | 2000-10-26 |
| SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002564) | The Binding Site, Ltd. | 2000-10-26 |
| SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT (K002560) | The Binding Site, Ltd. | 2000-10-26 |
| ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (K002376) | Bayer Corp. | 2000-10-26 |
| HARDYDISK CEFOTETAN, 30MCG (K002661) | Hardy Diagnostics | 2000-10-26 |
| ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS (K002577) | Medivance, Inc. | 2000-10-26 |
| SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (K002561) | The Binding Site, Ltd. | 2000-10-26 |
| HARDYDISK LOMEFLOXACIN, 10MCG (K002660) | Hardy Diagnostics | 2000-10-26 |
| STACKHOUSE LENS HOOD, MODEL SA-700/FS (K003194) | Stackhouse, Inc. | 2000-10-26 |
| EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 (K002531) | Toshiba America Mri, Inc. | 2000-10-26 |
| NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA (K002335) | Sulzer Orthopedics, Inc. | 2000-10-25 |
| HARDYDISK CEFUROXIME, 30MCG (K002656) | Hardy Diagnostics | 2000-10-25 |
| OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER (K002982) | Olympus America, Inc. | 2000-10-25 |
| OPART, MODEL MRT-600 (K002522) | Toshiba America Mri, Inc. | 2000-10-25 |
| K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE (K002558) | Kamiya Biomedical Co. | 2000-10-25 |
| HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (K003221) | Harald Nordin S.A | 2000-10-25 |
| DIRECT CROWN (K001884) | Flexible Dimensions, LLC | 2000-10-25 |
| HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (K003219) | Harald Nordin S.A | 2000-10-25 |
| OSCAR 2, MODEL 222 (K003004) | Suntech Medical Instruments, Inc. | 2000-10-25 |
| HARDYDISK STREPTOMYCIN, 300MCG (K002368) | Hardy Diagnostics | 2000-10-25 |
| OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT (K002918) | Olympus America, Inc. | 2000-10-25 |
| CARDIOBEEPER CB12/12, MODEL CB12/12 (K002310) | Meridian Medical Technologies , Ltd. | 2000-10-25 |
| RAICHEM PHOSPORUS REAGENT (K003012) | Hemagen Diagnostics, Inc. | 2000-10-25 |
| DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (K001493) | Air Force, Inc. | 2000-10-25 |
| MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM (K002675) | Product Development Industries, Inc. | 2000-10-25 |
| ACCESS ALERT GAUGE (K002372) | Medisystems Corp. | 2000-10-25 |
| NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM (K001811) | Neu-Ion, Inc. | 2000-10-25 |