| SOPRANO CRYO-THERAPY SYSTEM (K980393) | Gynecare Innovation Center | 1998-05-01 |
| KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 (K980508) | Micro Specialties, Inc. | 1998-05-01 |
| IRMA BLOOD ANALYSIS SYSTEM (K981270) | Diametrics Medical, Inc. | 1998-05-01 |
| TBIL (K981336) | Abbott Laboratories | 1998-05-01 |
| HEELBO WAIST AND CHEST VEST (K980640) | Heelbo, Inc. | 1998-05-01 |
| MG (K981192) | Abbott Laboratories | 1998-05-01 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (K981354) | Beckman Instruments, Inc. | 1998-05-01 |
| BIO-POST DENTAL POST SYSTEM (K974649) | Advanced Aeromedical, Inc. | 1998-05-01 |
| N-ASSAY L D-BIL (K981276) | Crestat Diagnostics, Inc. | 1998-05-01 |
| IRON (K981241) | Abbott Laboratories | 1998-05-01 |
| IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (K980833) | Diagnostic Products Corp. | 1998-05-01 |
| GLASS VAN GLASS SYRINGES (K963364) | Myco Medical Supplies, Inc. | 1998-05-01 |
| TROVAFLOXACIN 10G, SENSI-DISC (K980683) | Becton Dickinson Microbiology Systems | 1998-05-01 |
| EBNA-1 IGM ELISA TEST SYSTEM (K980598) | Clark Laboratories, Inc. | 1998-05-01 |
| PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS (K981368) | Catheter Innovations, Inc. | 1998-05-01 |
| ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER (K980815) | Ethicon Endo-Surgery, Inc. | 1998-05-01 |
| PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) (K980616) | Kohler Medizintechnik GmbH & Co. KG | 1998-04-30 |
| E100 SERIES SPO2 SENSORS (K970098) | Epic Medical Equipment Services, Inc. | 1998-04-30 |
| RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC (K972705) | Sage Products, Inc. | 1998-04-30 |
| PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 (K980400) | Peregrine Surgical , Ltd. | 1998-04-30 |
| CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS (K981280) | Bayer Corp., Agfa Div. | 1998-04-30 |
| MOOORLDI LASER DOPPLER IMAGER (K980383) | Moor Instruments, Ltd. | 1998-04-30 |
| NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) (K970460) | Puritan Bennett Corp. | 1998-04-30 |
| MENTOR SUSPEND SLING (K980483) | Mentor Corp. | 1998-04-30 |
| CS2000 & CS2000 TOMO (K973834) | Pausch Corp. | 1998-04-30 |
| DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H (K980534) | The Heart Valve Div. Medtronic Cardiovascular Surg | 1998-04-30 |
| PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 (K980399) | Peregrine Surgical , Ltd. | 1998-04-30 |
| MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR (K970211) | Micro Weiss Electronics | 1998-04-30 |
| JUMBO GLASS IONOMER CEMENT (K980568) | Centrix, Inc. | 1998-04-30 |
| GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (K971377) | Wilson Greatbatch Technologies, Inc. | 1998-04-30 |
| MEDRAD ATD-T INTERFACE DEVICE (K974438) | Medrad, Inc. | 1998-04-30 |
| MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO (K970139) | Micro Weiss Electronics | 1998-04-30 |
| PROTEC CEM. (K980922) | Ivoclar North America, Inc. | 1998-04-30 |
| TOENNIES NEUROSCREEN SYSTEM (K972419) | Erich Jaeger, Inc. | 1998-04-30 |
| SPIROMETER MODEL NPB-500 (K980441) | Nellcor Puritan Bennett, Inc. | 1998-04-30 |
| QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (K973335) | Zenyx Scientific , Ltd. | 1998-04-30 |
| BAIR HUGGER BLOOD/FLUID WARMER (K973741) | Augustine Medical, Inc. | 1998-04-30 |
| N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE (K980623) | N-Tech Endoscopy, Inc. | 1998-04-30 |
| SILICONE PUNCTAL PLUG (K980437) | Oasis Medical, Inc. | 1998-04-30 |
| KLEENASEPTIC (K981023) | Metrex Research Corp. | 1998-04-30 |
| SIS WOUND DRESSING (K973170) | Cook Biotech, Inc. | 1998-04-30 |
| PEAK FLOW METER MINIMAX (K980443) | The D&T, Inc. | 1998-04-30 |
| INNOVASIVE LINX TIBIAL LIGAMENT FASTENER (K980491) | Innovasive Devices, Inc. | 1998-04-29 |
| INNOVASIVE DEVICES MENISCAL SCREW (K980681) | Innovasive Devices, Inc. | 1998-04-29 |
| ABBOTT AXSYM 3RD GENERATION TSH ASSAY (K981060) | Abbott Laboratories | 1998-04-29 |
| DUMEX PAK-ITS WOVEN RIBBON PACKING (K980791) | Dumex Medical Surgical Products, Ltd. | 1998-04-29 |
| SURETOUCH (K980784) | Sahar Technologies, Inc. | 1998-04-29 |
| BRIGHTSTAR (K981081) | Hill-Rom, Inc. | 1998-04-29 |
| ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE (K980373) | Ultramind International , Ltd. | 1998-04-29 |
| SIGMA DIAGNOSTICS ACCUCLOT CONTROL I (K981248) | Sigma Diagnostics, Inc. | 1998-04-29 |
| SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES (K980360) | Scimed Life Systems, Inc. | 1998-04-29 |
| SIGMA DIAGNOSTICS ACCUCLOT CONTROL III (K981255) | Sigma Diagnostics, Inc. | 1998-04-29 |
| CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM (K974674) | Cynosure, Inc. | 1998-04-29 |
| THE NUFFIELD TOTAL KNEE SYSTEM (K980545) | Corin USA | 1998-04-29 |
| ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST (K980776) | Tcpi, Inc. | 1998-04-29 |
| SIGMA DIAGNOSTICS ACCUCLOT CONTROL II (K981254) | Sigma Diagnostics, Inc. | 1998-04-29 |
| ACROMED TIMX PLATE BASED LOW BACK SYSTEM (K981274) | Acromed Corp. | 1998-04-29 |
| HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS (K980364) | Howmedica Corp. | 1998-04-29 |
| OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS (K980774) | Osteonics Corp. | 1998-04-29 |
| OSSEOTITE DENTAL IMPLANT SYSTEM (K980549) | Implant Innovations, Inc. | 1998-04-28 |
| I.V. CATHETER SYSTEM (K980493) | Johnson & Johnson Medical, Inc. | 1998-04-28 |
| VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 (K980350) | Cuda Products Co. | 1998-04-28 |
| BABYPAC (K970158) | Pneupac, Inc. | 1998-04-28 |
| ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) (K980346) | Universal Technology Systems, Inc. | 1998-04-28 |
| HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED (K980848) | P.T. Irama Dinamika Latex | 1998-04-28 |
| NTECH CYSTOSCOPES (K980592) | N-Tech Endoscopy, Inc. | 1998-04-28 |
| EASY ECG PC BASED ELECTROCARDIOGRAPH (K972996) | Ates Medical S.R.L. | 1998-04-28 |
| SYNTHES SCHUHLI IMPLANT SYSTEM (K980944) | Synthes (Usa) | 1998-04-27 |
| MANAN VS ACCESS NEEDLE/SET (K980372) | Medical Device Technologies, Inc. | 1998-04-27 |
| INNOVASIVE 10MM LINX HT LIGAMENT FASTENER (K980334) | Innovasive Devices, Inc. | 1998-04-27 |
| PALFIQUE ESTELITE (K980054) | Tokuyama America, Inc. | 1998-04-27 |
| EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE (K980583) | Sims Deltec, Inc. | 1998-04-27 |
| THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS (K981178) | Cardiovascular Diagnostics, Inc. | 1998-04-27 |
| TOKUSO MAC BOND II (K980058) | Tokuyama America, Inc. | 1998-04-27 |
| CLASS III REVERSE PULL FACEMASK (K980436) | Ortho Kinetics Corp. | 1998-04-27 |
| STRATUS CS CARDIAC TROPONIN I TESTPAK (K981098) | Dade Behring, Inc. | 1998-04-27 |
| AUTOTRANSFUSION APPARTUS (AUTOLOG) (K972894) | Medtronic Blood Management | 1998-04-27 |
| HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (K980772) | Diagnostic Chemicals , Ltd. | 1998-04-27 |
| PELVX INCONTINENCE RING (K974116) | Deschutes Medical Products, Inc. | 1998-04-27 |
| CSS-CARDIOPLEGIA SAFETY SYSTEM (K973237) | Medtronic Bio-Medicus, Inc. | 1998-04-27 |
| STRATUS CS MYOGLOBIN (MYO) TESTPAK (K981102) | Dade Behring, Inc. | 1998-04-27 |
| PELVX RING, PELVX RING WITH SUPPORT (K974115) | Deschutes Medical Products, Inc. | 1998-04-27 |
| PELVX DONUT, PELVX CUBE (K974117) | Deschutes Medical Products, Inc. | 1998-04-27 |
| BIOGOLD PLUS DENTAL ALLOY (K980660) | European Dental Imports, Inc. | 1998-04-27 |
| N-ASSAY L T-BIL (K981289) | Crestat Diagnostics, Inc. | 1998-04-27 |
| AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER (K972911) | United States Surgical, A Division of Tyco Healthc | 1998-04-25 |
| URESIL DILATOR WITH RADIOPAQUE MARKER (K980282) | Uresil Corp. | 1998-04-24 |
| ELECSYS CALCHECK FERRITIN (K981281) | Roche Diagnostics GmbH | 1998-04-24 |
| KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER (K980357) | Konan, Inc. | 1998-04-24 |
| SERAQUEST ANTI-DSDNA (K980391) | Quest Intl., Inc. | 1998-04-24 |
| STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM (K980276) | Stelkast Company | 1998-04-24 |
| ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL (K974840) | Roche Diagnostic Systems, Inc. | 1998-04-24 |
| SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING (K980557) | Siemens Medical Solutions USA, Inc. | 1998-04-24 |
| PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE (K972793) | Radi Medical Systems AB | 1998-04-24 |
| ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS (K980614) | Abbott Laboratories | 1998-04-24 |
| MECTEST (K973986) | Meco Industries | 1998-04-24 |
| DIRECT BILIRUBIN (DBIL) (K981222) | Abbott Laboratories | 1998-04-24 |
| ACL CLIP-IN PLATE (K973874) | Innovasive Devices, Inc. | 1998-04-24 |
| APEX OXIMETER (K980299) | Marquette Medical Systems, Inc. | 1998-04-24 |
| IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 (K973556) | Imex Medical Systems, Inc. | 1998-04-24 |