| MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE (K011593) | Ansell Healthcare Products, Inc. | 2001-06-21 |
| EMBOGOLD MICROSPHERE (K010026) | Biosphere Medical, Inc. | 2001-06-21 |
| MEDCOMP ASH SPLIT (K011576) | Medical Components, Inc. | 2001-06-21 |
| BIOSCANNER CREATININE TEST STRIPS (K010456) | Polymer Technology Systems, Inc. | 2001-06-20 |
| DRIDAU OPIATE ASSAY (K011150) | Microgenics Corp. | 2001-06-20 |
| THIN FILM DRESSING FOR ULTRASOUND EXAM (K011284) | Martin E. Wendelken | 2001-06-20 |
| TITANIUM COMPRESSION ANCHOR SYSTEM (K010884) | Anchor Medical Technologies | 2001-06-20 |
| NTI TENSION SUPPRESSION SYSTEM (K010876) | Nti-Tss, Inc. | 2001-06-20 |
| NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET (K011297) | Nipro Medical Corp. | 2001-06-20 |
| Q-RAD RADIOGRAPHIC SYSTEM (K011486) | Quantum Medical Imaging, LLC | 2001-06-20 |
| ACCU-CHEK ACTIVE SYSTEM (K011738) | Roche Diagnostics Corp. | 2001-06-20 |
| JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G (K010406) | Jms Co., Ltd. | 2001-06-20 |
| HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 (K011656) | Micro Therapeutics, Inc. | 2001-06-20 |
| PTW DOSIMETRY DIODE, T60008 (K010916) | Ptw-New York Corp. | 2001-06-20 |
| ZIEHM VISION (K011292) | Ziehm International, Inc. | 2001-06-20 |
| SEALAPEX 4 (K010940) | Sybron Dental Specialties, Inc. | 2001-06-20 |
| JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (K010410) | Jms Co., Ltd. | 2001-06-20 |
| PFC SIGMA LUGGED TIBIAL TRAY (K003026) | DePuy Orthopaedics, Inc. | 2001-06-19 |
| TORNIER TOTAL ELBOW PROSTHESIS (K011567) | Tornier | 2001-06-19 |
| RESORBABLE HAMMERTOE PIN (K011137) | Biomet, Inc. | 2001-06-19 |
| K'FIX (K010847) | Avanta Orthopaedics, Inc. | 2001-06-19 |
| OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S (K011577) | Ocu-Ease Optical Products, Inc. | 2001-06-19 |
| MEDPOR QUAD MOTILITY IMPLANT (K010902) | Porex Surgical, Inc. | 2001-06-19 |
| MODIFICATION TO PROLITE PULSED LIGHT SYSTEM (K010927) | Medical Bio Care Sweden AB | 2001-06-19 |
| KSEA MINIATURE TELESCOPE AND ACCESSORIES (K010987) | KARL STORZ Endoscopy-America, Inc. | 2001-06-19 |
| FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM (K010988) | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-19 |
| ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 (K011634) | Arthrocare Corp. | 2001-06-19 |
| RADIAL HEAD IMPLANT (K011819) | Avanta Orthopaedics, Inc. | 2001-06-19 |
| PROLITE VL PULSED LIGHT SYSTEM (K010928) | Medical Bio Care Sweden AB | 2001-06-19 |
| INTERLINK THREADED LOCK CANNULA (K011858) | Bd | 2001-06-19 |
| SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS (K011187) | Sterling Medivations, Inc. | 2001-06-19 |
| MERIDIAN-PORTABLE (K010897) | Meridian Co., Ltd. | 2001-06-19 |
| FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B (K010901) | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-19 |
| ARTHREX BIO-TRANSFIX (K011172) | Arthrex, Inc. | 2001-06-19 |
| PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY (K010553) | Abbott Laboratories | 2001-06-18 |
| FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW (K011211) | Dmg USA, Inc. | 2001-06-18 |
| LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113 (K010870) | Ethicon Endo-Surgery, Inc. | 2001-06-18 |
| IBD-CHEK (K011396) | Techlab, Inc. | 2001-06-18 |
| RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET (K010974) | Sorin Group Italia S.R.L. | 2001-06-18 |
| EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (K011620) | Syva Co., Dade Behring, Inc. | 2001-06-18 |
| CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 (K011548) | Medical Analysis Systems, Inc. | 2001-06-18 |
| OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS (K011622) | Howmedica Osteonics Corp. | 2001-06-15 |
| CRYOCARE CARDIAC SURGICAL SYSTEM (K011040) | Endocare, Inc. | 2001-06-15 |
| ACTI-ICP MONITORING SYSTEM (K003905) | Innerspace, Inc. | 2001-06-15 |
| HANDMASTER (K010837) | Neuromusclar Electrical Stimulation Systems, Ltd. | 2001-06-15 |
| QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) (K011572) | Digirad Corp. | 2001-06-15 |
| MX8000 V5.0 CT SYSTEM (K010817) | Philips Medical Systems (Cleveland), Inc. | 2001-06-15 |
| OMNILINK .035 BILIARY STENT SYSTEM (K011506) | Guidant Corp. | 2001-06-15 |
| CORDIS M3 PTA DILATATION CATHETER (K003920) | Cordis Corp. | 2001-06-15 |
| EXETER HIP SYSTEM WITH V40 TAPER (K011623) | Howmedica Osteonics Corp. | 2001-06-15 |
| OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE (K011183) | Advanced Surgical Concepts (Asc) | 2001-06-15 |
| EEG MIS MONITOR MODEL # A-2000; BIS ENGINE (K011534) | Aspect Medical Systems, Inc. | 2001-06-15 |
| EXCEL FRACTURE CEMENTED HIP STEM (K011367) | DePuy Orthopaedics, Inc. | 2001-06-15 |
| NTERO NOMAD SYSTEM (K010815) | Ntero Surgical, Inc. | 2001-06-15 |
| MALE NATURAL RUBBER LATEX CONDOM (K010919) | Innolatex Sdn. Bhd | 2001-06-15 |
| NEURO-TRAIN III (3) (K003433) | Sterne Equipment Co., Ltd. | 2001-06-15 |
| MODIFICATION TO THE BOLD SCREW (K011262) | New Deal, S.A. | 2001-06-15 |
| PORTABLE INSTENSIVE CARE UNIT (K010207) | Medical Research Laboratories, Inc. | 2001-06-14 |
| PULSECO HEMODYNAMIC MONITOR CM71 (K010049) | Lidco, Ltd. | 2001-06-14 |
| ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 (K011523) | Rossmax International , Ltd. | 2001-06-14 |
| BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K011446) | Barriermed, Inc. | 2001-06-14 |
| BCI 3403 SLEEP SCREENING PULSE OXIMETER (K011156) | Bci, Inc. | 2001-06-14 |
| COMOACT ULTRASONIC NEBULIZER, MODEL 3060 (K002543) | San UP S.A. | 2001-06-14 |
| NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 (K010093) | Drager Medizintechnik GmbH | 2001-06-14 |
| DIMENSION DRUG CALIBRATOR, MODEL DC22B (K011035) | Dade Behring, Inc. | 2001-06-14 |
| COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH (K010055) | Cook Vascular, Inc. | 2001-06-14 |
| GILB, MODEL 8010 (K011200) | 3M Company | 2001-06-14 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 (K011526) | Micro Therapeutics, Inc. | 2001-06-14 |
| SLT LASERPRO CTH HOLMIUM LASER SYSTEM (K011409) | Surgical Laser Technologies, Inc. | 2001-06-14 |
| CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN (K011231) | Protection Gloves Sdn. Bhd. | 2001-06-13 |
| MEMODYN STAPLE (K002695) | Telos Medical Equipment | 2001-06-13 |
| LUNAPADS (K010986) | Lunapads International Products, Ltd. | 2001-06-13 |
| OIL FOR TISSUE CULTURE (K011462) | Conception Technologies | 2001-06-13 |
| PLLA PIN (K010983) | Bionx Implants, Inc. | 2001-06-13 |
| ULTRACONCENTRATOR SYSTEM (K011148) | Interpore Cross Intl. | 2001-06-13 |
| SILICONE IMPRESSION MATERIAL (K011450) | Northeast Resins & Silicones, LLC | 2001-06-13 |
| WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE (K011598) | Irvine Scientific Sales Co., Inc. | 2001-06-13 |
| MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM (K011095) | Iodp SA | 2001-06-13 |
| SELF-ADHESIVE ELECTRODES (K011411) | Pain Management Technologies | 2001-06-13 |
| AVIATOR PERIPHERAL DILATATION CATHETER (K010831) | Guidant Corp. | 2001-06-13 |
| NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI (K011125) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 (K011384) | Hardy Diagnostics | 2001-06-13 |
| OXYGEN SUPPLY TUBING, MODEL 1115 (K011134) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 (K003259) | Beckman Coulter, Inc. | 2001-06-13 |
| BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L (K011234) | American Biocurve, Inc. | 2001-06-13 |
| PROACT 1 (K003909) | Proact Co. | 2001-06-13 |
| WORLAND UNICONDYLAR TIBIAL BEARING (K011795) | Biomet, Inc. | 2001-06-13 |
| YOUNG-HEALTH SUPER EAR THERMOMETER (K002727) | Young Health Ind. Co., Ltd. | 2001-06-13 |
| BD SPRING BASED SYRINGE (K011103) | Bd | 2001-06-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS (K011463) | Ortho-Clinical Diagnostics | 2001-06-13 |
| TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 (K011693) | Trumpf Medical Systems, Inc. | 2001-06-13 |
| BARRETT UNICONDYLAR TIBIAL BEARING (K011509) | Biomet, Inc. | 2001-06-13 |
| HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) (K011113) | Sebia | 2001-06-13 |
| FORTADERM WOUND DRESSING (K011026) | Organogenesis, Inc. | 2001-06-13 |
| FAST THERMOMETER MODELS ST713C AND ST713F (K011585) | Mesure Technology | 2001-06-13 |
| RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN (K011464) | Vascular Intervention | 2001-06-13 |
| CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) (K010854) | Protection Gloves Sdn. Bhd. | 2001-06-13 |
| BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T (K011316) | American Contact Lens, Inc. | 2001-06-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K011250) | Ortho-Clinical Diagnostics, Inc. | 2001-06-13 |
| BIOCELLECT (K010775) | Imtec Corp. | 2001-06-12 |