| SERAQUEST ANTI-SM/RNP (K980811) | Quest Intl., Inc. | 1998-05-12 |
| ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE (K981256) | Ximed/Prosure/Injectx | 1998-05-12 |
| LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW (K980512) | Walter Lorenz Surgical, Inc. | 1998-05-11 |
| PHILIPS GYROSCAN NT RELEASE 6 SERIES (K980645) | Philips Medical Systems North America, Inc. | 1998-05-11 |
| DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) (K980863) | Dumex Medical Surgical Products, Ltd. | 1998-05-11 |
| INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER (K981327) | Idem (Int'L Dist. of Electronics For Medicine) | 1998-05-11 |
| HAKOMED ELECDT / PRO ELEDT SERIES (K980892) | Alive, Inc. | 1998-05-11 |
| EXTENTRAC (K980021) | Advanced Back Technologies | 1998-05-11 |
| THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT (K974038) | A & A Medical, Inc. | 1998-05-11 |
| PROCAD (K980986) | Ivoclar USA, Inc. | 1998-05-11 |
| AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K980691) | Hitachi Medical Systems America, Inc. | 1998-05-11 |
| LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER (K980809) | Lumisys, Inc. | 1998-05-11 |
| HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) (K980963) | Foremost Dental Mfg., Inc. | 1998-05-11 |
| HAKOMED ELECDT/VACUPULLS (K980958) | Alive, Inc. | 1998-05-11 |
| REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE (K980942) | London International Group, Inc. | 1998-05-11 |
| SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM (K980928) | Synthes Spine | 1998-05-11 |
| BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) (K980741) | Polymer Technology Div. Wilmington Partners, L.P. | 1998-05-11 |
| CORDIS VANGUARD STEERABLE GUIDEWIRES (K974560) | Cordis Corp. | 1998-05-11 |
| SURGIDEV SILICONE PUNCTUM PLUG (K980844) | Advanced Vision Science | 1998-05-11 |
| DEPUY ORTHOTECH CATERA SUTURE ANCHOR (K980595) | DePuy Orthopaedics, Inc. | 1998-05-11 |
| SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE (K980704) | Aesculap, Inc. | 1998-05-11 |
| ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE (K981392) | Ansell Perry | 1998-05-11 |
| SOFSILK SUTURE (K981128) | United States Surgical, A Division of Tyco Healthc | 1998-05-11 |
| OSTEO 4.0MM CANNULATED SCREW SYSTEM (K981259) | Osteonics Corp. | 1998-05-11 |
| HERNIAMESH SURGICAL MESHES (K973955) | Herniamesh | 1998-05-11 |
| AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (K980988) | Axya Medical, Inc. | 1998-05-11 |
| CARDIOSTATION (K980624) | Universal Medical, Inc. | 1998-05-11 |
| SYNTHES 3.0 MM PC-FIX SYSTEM (K981372) | Synthes (Usa) | 1998-05-11 |
| STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB (K981516) | Sterngold/Implamed | 1998-05-11 |
| MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M (K973561) | Medical Components, Inc. | 1998-05-11 |
| C/T MED-SYSTEMS CASSETTE SYSTEM (K980065) | C/T Med System, Ltd. | 1998-05-11 |
| PRINCESS SYRINGE (K980577) | Sodexco | 1998-05-08 |
| COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM (K981505) | Sonosite,Inc. | 1998-05-08 |
| SONOACE 6000/ ULTRAMARK 400 (K981510) | Medison America, Inc. | 1998-05-08 |
| ENDO FMS UROLOGY (K980808) | Future Medical Systems, Inc. | 1998-05-08 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (K981403) | Beckman Instruments, Inc. | 1998-05-08 |
| KSEA PLASTIC TROCARS (K980694) | KARL STORZ Endoscopy-America, Inc. | 1998-05-08 |
| URIC ACID (K981189) | Abbott Laboratories | 1998-05-07 |
| VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981079) | Impra, Inc. | 1998-05-07 |
| VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981076) | Impra, Inc. | 1998-05-07 |
| FRIOS BONESHIELD (K973924) | Friatec AG | 1998-05-07 |
| BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER (K973646) | Bird Products Corp. | 1998-05-07 |
| QUICK CHECK INSTANT THERMOMETER (K971831) | Ejb Medical, Inc. | 1998-05-07 |
| QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST (K981019) | Syntron Bioresearch, Inc. | 1998-05-07 |
| CONTROLLED TEMPERATURE CABINET SYSTEM (K973747) | Smith | 1998-05-07 |
| OLYMPUS SERUM PROTEIN MULTICALIBRATOR (K981305) | Olympus America, Inc. | 1998-05-07 |
| DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS (K981472) | Draeger Medical, Inc. | 1998-05-07 |
| TRIMPORT (K974533) | Gerard Medical, Inc. | 1998-05-07 |
| GLU (K981185) | Abbott Laboratories | 1998-05-07 |
| CARESIDE GLUCOSE (K981183) | Exigent Diagnostics, Inc. | 1998-05-07 |
| CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (K981474) | Spectral Diagnostics, Inc. | 1998-05-07 |
| MUSE CARDIOVASCULAR INFORMATION SYSTEM (K980495) | Marquette Medical Systems, Inc. | 1998-05-07 |
| SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT (K980445) | Spectrum Designs, Inc. | 1998-05-06 |
| QUICK-CUT AUTOMATIC BIOPSY SYSTEM (K980479) | Gallini U.S., LLC | 1998-05-06 |
| SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT (K980463) | Spectrum Designs, Inc. | 1998-05-06 |
| VR NETSERVE (K980684) | I.S.G. Technologies, Inc. | 1998-05-06 |
| ECHOTECH 3D FREESCAN (K980308) | Echotech 3D Imaging Systems GmbH | 1998-05-06 |
| IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES (K980646) | Instrumentation Laboratory CO | 1998-05-06 |
| FACTS MONOBLOCK (K981267) | Dynarad Corp. | 1998-05-06 |
| VSS, VIRTUAL SIMULATION SYSTEM (K980629) | Nucletron Corp. | 1998-05-06 |
| NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM (K980246) | Canon USA, Inc. | 1998-05-06 |
| XTEND (K980752) | Walling Medical Equipment Co. | 1998-05-06 |
| SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT (K980462) | Spectrum Designs, Inc. | 1998-05-06 |
| CHARGER (ED) (K980567) | Walling Medical Equipment Co. | 1998-05-06 |
| AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) (K980715) | Adac Laboratories | 1998-05-06 |
| DIFFUSION PACKAGE / GYROSCAN NT (K973658) | Philips Medical Systems North America, Inc. | 1998-05-06 |
| SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT (K980444) | Spectrum Designs, Inc. | 1998-05-06 |
| SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT (K980446) | Spectrum Designs, Inc. | 1998-05-06 |
| OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR (K972020) | Cas Medical Systems, Inc. | 1998-05-05 |
| JOBST ATHROMBIC PUMP SYSTEM 2600 (K980456) | Jobst A Beiersdorf Co. | 1998-05-05 |
| OSTEONICS FX-CABLELOK GRIP COMPONENTS (K980594) | Osteonics Corp. | 1998-05-05 |
| ONPLANT ORTHODONTIC SYSTEM (K980460) | Nobel Biocare Uas, Inc. | 1998-05-05 |
| EXEL AVF SINGLE NEEDLE (K963658) | Exel Intl. | 1998-05-05 |
| OSTEONICS TOTAL ELBOW SYSTEM (K980502) | Osteonics Corp. | 1998-05-05 |
| BIOMET BIAXIAL TOTAL ELBOW (K980428) | Biomet, Inc. | 1998-05-05 |
| LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING (K980827) | Tucker & Associates | 1998-05-04 |
| SYNTEC VITMAN (K980480) | Syntec, Inc. | 1998-05-04 |
| PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE (K980703) | Aesculap, Inc. | 1998-05-04 |
| DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING (K980777) | Dumex Medical Surgical Products, Ltd. | 1998-05-04 |
| MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V (K980417) | Medrad, Inc. | 1998-05-04 |
| LIGHTSHEER (K980420) | Palomar Medical Products, Inc. | 1998-05-04 |
| REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (K980650) | Helena Laboratories | 1998-05-01 |
| ENDOSOLV E (K980633) | Specialites Septodont | 1998-05-01 |
| IMMULITE ANTI-TG AB (K980206) | Diagnostic Products Corp. | 1998-05-01 |
| COAMATIC PLASMINOGEN (K974711) | Instrumentation Laboratory CO | 1998-05-01 |
| BRONCHIAL CATHETER SYSTEM (K980046) | Broncus Technologies, Inc. | 1998-05-01 |
| TRIP TONOMETRY CATHETER, 18F (K980384) | Datex-Engstrom, Inc. | 1998-05-01 |
| SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL (K980965) | Cavex Holland BV | 1998-05-01 |
| SCMD-1000 (K980985) | Howard Instruments, Inc. | 1998-05-01 |
| CERA E DENTAL ALLOY (K980661) | European Dental Imports, Inc. | 1998-05-01 |
| GII SPINAL FIXATION SYSTEM (K980852) | Karen E. Warden, M.E.B.E. | 1998-05-01 |
| OAC (OPTICAL ASPIRATING CURETTE) (K980096) | Imagyn Medical Technologies, Inc. | 1998-05-01 |
| BACTEC MGIT 960 SYSTEM (K974883) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-05-01 |
| CREATINE KINASE (CK) (K981218) | Abbott Laboratories | 1998-05-01 |
| ELECSYS AFP (K981282) | Roche Diagnostics GmbH | 1998-05-01 |
| B-D ASSURE EAR THERMOMETER (K971994) | Becton Dickinson Consumer Products | 1998-05-01 |
| CMVGEN (K974456) | Instrumentation Laboratory CO | 1998-05-01 |
| KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) (K980510) | Micro Specialties, Inc. | 1998-05-01 |
| DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES (K980385) | Datascope Corp. | 1998-05-01 |
| PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS (K981382) | Catheter Innovations, Inc. | 1998-05-01 |