| ACQPLAN (K974770) | Philips Medical Systems (Cleveland), Inc. | 1998-09-02 |
| PIV SYSTEM (K981032) | Medical Solutions, Inc. | 1998-09-02 |
| QUANTI-TEST SYSTEM (K982578) | Panatrex, Inc. | 1998-09-02 |
| NUCAMMA R+ (K982044) | Is2 Research, Inc. | 1998-09-02 |
| MODEL MS-2 HANDPIECE (K982050) | Parkell, Inc. | 1998-09-02 |
| ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 (K982501) | Alko Diagnostic Corp. | 1998-09-01 |
| COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER (K981952) | Instruments For Medicine and Diagnostics | 1998-09-01 |
| ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS (K982904) | Les Laboratoires Blanchard | 1998-09-01 |
| VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM (K982345) | Cardiac Mariners, Inc. | 1998-09-01 |
| PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE (K980762) | Pall Corp. | 1998-09-01 |
| COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K981168) | Allergan, Inc. | 1998-09-01 |
| ESOPHAGEAL STETHOSCOPE (K982193) | Shore Medical, Inc. | 1998-09-01 |
| SULLIVAN AUTOSET (K980721) | Resmed, Ltd. | 1998-09-01 |
| SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM (K982155) | Influence, Inc. | 1998-08-31 |
| UNI/MONOPOLAR HF CABLE (K982677) | Richard Wolf Medical Instruments Corp. | 1998-08-31 |
| MANUAL WHEELCHAIR (K982607) | G. Hirsch and Co., Inc. | 1998-08-31 |
| PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW (K982900) | Depuy, Inc. | 1998-08-31 |
| FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH (K981066) | Fukuda Denshi USA, Inc. | 1998-08-31 |
| THE BAGNOLI-4 EMG SYSTEM (K981934) | Delsys, Inc. | 1998-08-31 |
| HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A (K982248) | Howmedica, Inc. | 1998-08-31 |
| IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) (K964977) | Interactive Living Systems, Inc. | 1998-08-31 |
| VAPAMASTA 6 (K980489) | Medical Industrial Equipment | 1998-08-31 |
| HEMOSITE TEST SYSTEM (K973649) | Gds Technology, LLC | 1998-08-31 |
| SCOUT (K982158) | Burke, Inc. | 1998-08-31 |
| HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM (K982068) | Howmedica Corp. | 1998-08-31 |
| MP-3 POWER BASE CHAIR (K982066) | Merits Health Products., Inc. | 1998-08-31 |
| ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 (K982141) | Arrow Intl., Inc. | 1998-08-31 |
| DEPUY ACE TIMAX PILON PLATE (K982347) | Depuy Ace Medical Co. | 1998-08-31 |
| LIGASURE VESSEL SEALING SYSTEM (K981916) | Valleylab, Inc. | 1998-08-28 |
| CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S (K982740) | Cordis Webster, Inc. | 1998-08-28 |
| ACCU-CHECK VOICEMATE (K982079) | Boehringer Mannheim Corp. | 1998-08-28 |
| AMY (K981653) | Abbott Laboratories | 1998-08-28 |
| POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) (K981011) | Pos-T-Vac, Inc. | 1998-08-28 |
| MODIFICATION TO EBI SPINELINK SYSTEM (K982908) | Electro-Biology, Inc. | 1998-08-28 |
| REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT (K981180) | Pos-T-Vac, Inc. | 1998-08-28 |
| 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME (K981705) | American Bio Medica Corp. | 1998-08-27 |
| ENDO-SCRUB/ENDO-SCRUB 2 (K982594) | Xomed, Inc. | 1998-08-27 |
| SLT BIPOLAR SHEATH (K981041) | Surgical Laser Technologies, Inc. | 1998-08-27 |
| 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS (K974090) | Fresenius Medical Care North America | 1998-08-27 |
| INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER (K973943) | Richard Wolf Medical Instruments Corp. | 1998-08-27 |
| CAOW HEMOSTASIS SYSTEM (K972689) | Anlam Corp. | 1998-08-27 |
| IL TEST PLASMIN INHIBITOR (K981696) | Instrumentation Laboratory CO | 1998-08-27 |
| QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA (K982366) | Inova Diagnostics, Inc. | 1998-08-27 |
| IMAGE POST-PROCESSING TECHNIQUES (K980831) | Philips Medical Systems (Cleveland), Inc. | 1998-08-27 |
| WHISTLE WATCH (K980550) | Harwill Medical (Pty) , Ltd. | 1998-08-27 |
| AU5 ULTRASOUND IMAGING SYSTEM (K980468) | Biosound Esaote, Inc. | 1998-08-26 |
| FETH-R-KATH (K981329) | Epimed International, Inc. | 1998-08-26 |
| AQUILION CT SCANNER, MODEL TSX-101A (K982265) | Toshiba America Medical Systems, In.C | 1998-08-26 |
| HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE (K982378) | Solution Technologies | 1998-08-26 |
| EC6 PLETHYSMOGRAPH (K982707) | D. E. Hokanson, Inc. | 1998-08-26 |
| ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE (K981897) | Roche Diagnostic Systems, Inc. | 1998-08-26 |
| ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K981801) | Princeton BioMeditech Corp. | 1998-08-25 |
| C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (K982442) | Care Wise Medical Products Corp. | 1998-08-25 |
| MT-200 (K973751) | Schiller America, Inc. | 1998-08-25 |
| MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K974220) | Micromedical, Inc. | 1998-08-25 |
| ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES (K982429) | Zymetx, Inc. | 1998-08-25 |
| BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5 (K973593) | Bridge Medical, Inc. | 1998-08-25 |
| ONE UP DISPOSABLE KERATOME HEAD (K981742) | Moria, Inc. | 1998-08-25 |
| CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY (K981931) | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-08-25 |
| MICROVIT MT-100 (K973735) | Schiller America, Inc. | 1998-08-25 |
| DIMENSION(R) VALPROIC (VALP) ACID METHOD (K982880) | Dade Behring, Inc. | 1998-08-25 |
| THE WAVE DIGITAL PHACO SYSTEM (K981989) | Circuit Tree | 1998-08-25 |
| STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) (K982061) | OraSure Technologies, Inc. | 1998-08-25 |
| VIVACAP HR (K982460) | Ab Ardent | 1998-08-24 |
| CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS (K982369) | Allegiance Healthcare Corp. | 1998-08-24 |
| THE SNORE PEACE (K981923) | The Snore Peace Group | 1998-08-24 |
| PEGASUS ND:YAG LASER SYSTEM (K980559) | Premier Laser Systems, Inc. | 1998-08-24 |
| REACH HIP COMPONENT (K982367) | Biomet, Inc. | 1998-08-24 |
| MITEK MICRO ANCHOR (K982420) | Mitek Products | 1998-08-24 |
| SUCTION CATHETER (K981910) | Ni-Med, Inc. | 1998-08-24 |
| TOKUYAMA SOFRELINER (K982537) | Tokuyama America, Inc. | 1998-08-24 |
| BREATHERITE (K981944) | Ventlab Corp. | 1998-08-24 |
| SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR (K982730) | Siemens Medical Solutions USA, Inc. | 1998-08-24 |
| GLASIONOMER CEMENT CX PLUS (K982461) | Shofu Dental Corp. | 1998-08-24 |
| AIRDENT RADIANCE CURING LIGHT (K982615) | Air Techniques, Inc. | 1998-08-24 |
| EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) (K980725) | Instrumentation Industries, Inc. | 1998-08-24 |
| MAGELLAN (K961903) | Biosense, Ltd. | 1998-08-24 |
| COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 (K980786) | Cobe Cardiovascular, Inc. | 1998-08-24 |
| TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 (K981971) | Bird Products Corp. | 1998-08-24 |
| VIVALLOY HR (K982458) | Ab Ardent | 1998-08-24 |
| MPS FIXED FLOW RATE SET (K982587) | Medical Product Specialists | 1998-08-24 |
| WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM (K981937) | Welch Allyn, Inc. | 1998-08-24 |
| ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES (K981272) | Electro Therapeutic Devices, Inc. | 1998-08-24 |
| AMALCAP PLUS (K982456) | Ab Ardent | 1998-08-24 |
| MEDWORKS INSEMINATION CATHETER (K982628) | Medworks Corp. | 1998-08-21 |
| PEDIATRIC INSTATRAK SYSTEM (K981998) | Visualization Technology, Inc. | 1998-08-21 |
| CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 (K982845) | More Diagnostics | 1998-08-21 |
| 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214 (K982638) | Innovative Technologies , Ltd. | 1998-08-21 |
| VES 1501-M (K982409) | Angiolaz, Inc. | 1998-08-21 |
| MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 (K981568) | Cdc Technologies, Inc. | 1998-08-21 |
| SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, (K974269) | Medison America, Inc. | 1998-08-21 |
| BIPOLAR FEMORAL HEAD (K981238) | Whiteside Biomechanics, Inc. | 1998-08-21 |
| SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (K980885) | Shield Diagnostics, Ltd. | 1998-08-21 |
| KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS (K982336) | Invacare Corp. | 1998-08-21 |
| AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP (K980976) | Hollister, Inc. | 1998-08-21 |
| ARGOMEDICAL BIPOLAR SYSTEM (K981451) | Stelkast Company | 1998-08-21 |
| BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 (K982238) | Binax, Inc. | 1998-08-21 |
| IS-TOXOPLASMA IGG TEST SYSTEM (K981498) | Diamedix Corp. | 1998-08-21 |
| GYNEX EXTENDED REACH NEEDLE (K980238) | Gynex Corp. | 1998-08-21 |
| OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (K981993) | The Olympus Optical Co. | 1998-08-21 |