| KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 (K042461) | Kendall | 2004-12-10 |
| PROMEDICAL SURGICAL DRAPES (K042131) | Promedical Products Co., Ltd. | 2004-12-10 |
| VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR (K032825) | Mars Medical Products Co., Ltd. | 2004-12-10 |
| MEDLEY PCA MODULE, MODEL 8120 (K043299) | Alaris Medical Systems, Inc. | 2004-12-10 |
| MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM (K042784) | Medrad, Inc. | 2004-12-10 |
| IR VIEWER (K042679) | Infrared Imaging Systems, Inc. | 2004-12-10 |
| KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE (K043114) | Kimberly-Clark Corp. | 2004-12-10 |
| TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) (K042099) | Retinapharma Technologies, Inc. | 2004-12-10 |
| ARTHREX SUTURE GRAFTING KIT (K041553) | Arthrex, Inc. | 2004-12-10 |
| BLUE ORTHOCORD SUTURE (K043298) | Depuy Mitek | 2004-12-10 |
| AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET (K042318) | Aalto Scientific, Ltd. | 2004-12-09 |
| CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 (K042588) | Confluent Surgical,Inc | 2004-12-09 |
| ACS MODEL NCP-2 (K042413) | Applied Cardiac Systems | 2004-12-09 |
| VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 (K043103) | Edwards Lifesciences, LLC | 2004-12-09 |
| BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER (K043117) | Best Medical International, Inc. | 2004-12-09 |
| AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) (K043041) | Aesculap, Inc. | 2004-12-09 |
| NICHOLS ADVANTAGE CORTISOL (K042689) | Nichols Institute Diagnostics | 2004-12-09 |
| MAGNETOM C! MR SYSTEM (K043030) | Siemens Medical Solutions | 2004-12-09 |
| OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER (K043275) | Olympus Medical Systems Corporation | 2004-12-09 |
| PRIMUS STENT AND DELIVERY SYSTEM (K043243) | Ev3, Inc. | 2004-12-09 |
| PATHFINDER (K041477) | Armstrong Healthcare Limited | 2004-12-09 |
| MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 (K043110) | Microlife Intellectual Property GmbH | 2004-12-09 |
| VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II (K042838) | Ortho-Clinical Diagnostics, Inc. | 2004-12-09 |
| STRYKER CASSETTE PUMP (K042454) | Stryker Endoscopy | 2004-12-09 |
| LIQUID STABLE HBA1C CONTROL (K043070) | Canterbury Scientific , Ltd. | 2004-12-09 |
| STARION UNIVERSAL POWER SUPPLY (UPS) (K043155) | Starion Instruments | 2004-12-09 |
| BICONTACT HIP SYSTEM WITH U-CAP (K043079) | Aesculap | 2004-12-08 |
| LPS UPPER EXTREMITY (K042664) | Depuy, Inc. | 2004-12-08 |
| TUF LINK SILICONE RELINER (K042931) | Dentatus USA , Ltd. | 2004-12-08 |
| EXPRESS AND OASIS CHEST DRAIN (K043140) | Atrium Medical Corp. | 2004-12-08 |
| VARELISA SM ANTIBODIES, MODEL 18296 (K042629) | Sweden Diagnostics (Germany) GmbH | 2004-12-08 |
| BIOZDX HEMODYNAMIC MONITOR (K041294) | Cardiodynamics International Corp. | 2004-12-08 |
| ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) (K042574) | Cardinalhealth | 2004-12-08 |
| COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM (K042970) | Copan Diagnostics, Inc. | 2004-12-07 |
| RIVA SILVER (K042452) | Southern Dental Industries, Inc. | 2004-12-07 |
| LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL (K043108) | Bio-Rad Laboratories, Inc. | 2004-12-07 |
| TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 (K042723) | Biosite Incorporated | 2004-12-07 |
| STERICHEK BLOOD LEAK REAGENT STRIPS (K042322) | Hach Company | 2004-12-07 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN (K042946) | bioMerieux, Inc. | 2004-12-07 |
| BARD INLAYOPTIMA URETERAL STENT WITH SUTURE (K043193) | C.R. Bard, Inc. | 2004-12-07 |
| AEQUOS (K033260) | Aap Implantate AG | 2004-12-07 |
| AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER (K040865) | Aesculap | 2004-12-06 |
| NEXFLEX TOTAL HIP SYSTEM (K042252) | Alphatec/Nexmed | 2004-12-06 |
| MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) (K042817) | Ansell Healthcare Products, Inc. | 2004-12-06 |
| OSTIM (K030052) | Heraeus Kulzer, Inc. | 2004-12-06 |
| H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM (K043186) | Health & Life Co., Ltd. | 2004-12-06 |
| FLEXI-STAT SP02 EAR SENSOR (K042675) | Elekon Industries U.S.A., Inc. | 2004-12-06 |
| HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256) | Hospira, Inc. | 2004-12-06 |
| ESTENIA C&B (K042929) | Kuraray Medical Kurashiki Plant | 2004-12-06 |
| UNIMIDE (K042284) | United Medical Industries Co. , Ltd. | 2004-12-03 |
| CERASYS - ZR (K042548) | Cerasys, Inc. | 2004-12-03 |
| PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 (K043023) | LeMaitre Vascular, Inc. | 2004-12-03 |
| HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES (K042148) | Ge Medical Syst. Information Technologies | 2004-12-03 |
| CONTOUR FOREHEAD/BROWLIFT THREAD (K042856) | Surgical Specialties Corp | 2004-12-03 |
| CORRECT DENTAL IMPRESSION MATERIAL (K042860) | Handae Chemical Co., Ltd. | 2004-12-03 |
| SHIMADZU COLLIMATOR R-20J (K042840) | Shimadzu Corp. | 2004-12-03 |
| BD ONECATH (K042862) | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-12-03 |
| HOVEROUND E100 POWER CHAIR (K043069) | Hoveround Corp. | 2004-12-03 |
| A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 (K042967) | A&D Engineering, Inc. | 2004-12-03 |
| HOVEROUND SE-3 POWERCHAIR (K042920) | Hoveround Corp. | 2004-12-03 |
| GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K042427) | Genemed, Inc. | 2004-12-03 |
| HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K043080) | Medtronic Vascular | 2004-12-03 |
| 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS (K042858) | Spire Biomedical, Inc. | 2004-12-03 |
| OLYMPUS LACTATE, OSR6193 (K042406) | Olympus America, Inc. | 2004-12-03 |
| ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM (K041834) | Takara Belmont USA, Inc. | 2004-12-03 |
| MODULAR ARTHRODESIS NAIL (K042409) | Biomet, Inc. | 2004-12-02 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML (K042932) | Becton, Dickinson & CO | 2004-12-02 |
| COATEST SP FVIII (K042576) | Instrumentation Laboratory CO | 2004-12-02 |
| WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES (K041693) | Hangzhou Hua'An Medical & Health Instruments Co., | 2004-12-02 |
| DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (K042941) | Dade Behring, Inc. | 2004-12-02 |
| MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 (K043027) | Applied Medical Technology, Inc. | 2004-12-02 |
| OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 (K042828) | Young O/S, LLC | 2004-12-01 |
| HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P (K042777) | Ethicon Endo-Surgery, Inc. | 2004-12-01 |
| VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS (K042476) | Ortho-Clinical Diagnostics, Inc. | 2004-12-01 |
| POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE (K041913) | Pt. Medisafe Technologies | 2004-12-01 |
| ULTRADENT CARBON MASK - UPI #342 (K041047) | Medspring Group, Incorporated | 2004-12-01 |
| MX POLYAXIAL PEDICLE SCREW (K043001) | Scient'X | 2004-12-01 |
| GAMMA-B 1,25-DIHYDROXY VITAMIN D (K042519) | Immunodiagnostic Systems , Ltd. | 2004-12-01 |
| MODIFICATION TO D-TRONPLUS (K043000) | Disetronic Medical Systems AG | 2004-12-01 |
| EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS (K041957) | Diomed, Inc. | 2004-12-01 |
| COSMEDENT PIT & FISSURE SEALANT (K042823) | Cosmedent, Inc. | 2004-12-01 |
| LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) (K043115) | Niti Medical Technologies , Ltd. | 2004-12-01 |
| CONTROL PLASMA N, PROC CONTROL PLASMA (K042333) | Dade Behring, Inc. | 2004-12-01 |
| UNIESTER C (K042286) | United Medical Industries Co. , Ltd. | 2004-12-01 |
| MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 (K033732) | Medtrade Products , Ltd. | 2004-12-01 |
| OUTPATIENT III MINOR SURGERY LIGHT (K042395) | Burton Medical Products Corp. | 2004-12-01 |
| SMARTWAVE MS 2000 (K041063) | Newwave Medical, LLC | 2004-12-01 |
| UNISILK (K042282) | United Medical Industries Co. , Ltd. | 2004-12-01 |
| VASCULAR SOLUTIONS SCLERO-KIT (K043019) | Vascular Solutions, Inc. | 2004-12-01 |
| DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE (K040888) | Collagen Matrix, Inc. | 2004-12-01 |
| UNIPRO (K042283) | United Medical Industries Co. , Ltd. | 2004-12-01 |
| DRAGON HEART PISTON SYRINGE (K042547) | Dragon Heart Medical Devices Co., Ltd. | 2004-12-01 |
| PUMP CONNECTIVITY INTERFACE (K040985) | Baxter Healthcare Corp | 2004-11-30 |
| VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III (K042520) | Ortho-Clinical Diagnostics, Inc. | 2004-11-30 |
| DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD (K042382) | Med-General Technologies, LLC | 2004-11-30 |
| OPTIV ANTAGE DH POWER INJECTION SYSTEM (K042744) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2004-11-30 |
| VAG O SPECULUM, MODELS VS1, VM1, VL1 (K042950) | Panatrex, Inc. | 2004-11-30 |
| SURGICAL DRAPE KIT - D.I.R.R.A. SRL (K041080) | D.I.R.R.A. S.R.L. | 2004-11-30 |
| ATRILAZE SOFT TISSUE ABLATION SYSTEM (K040744) | Medical Cv, Inc. | 2004-11-30 |
| ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM (K043196) | Aloka Co., Ltd. | 2004-11-30 |