| CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 (K980913) | Galil Medical , Ltd. | 1998-07-01 |
| PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 (K980087) | Pressure Products, Inc. | 1998-07-01 |
| SILCAST (CODE NAME RD-0118) (K981247) | J.F. Jelenko & Co., Inc. | 1998-07-01 |
| CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER (K971975) | Cardima, Inc. | 1998-07-01 |
| 7200 ULTRASOUND IMAGING SYSTEM (K981293) | Biosound Esaote, Inc. | 1998-06-30 |
| MRI COMPATIBLE MONITOR AND ACCESSORIES (K980362) | Datex-Engstrom, Inc. | 1998-06-30 |
| HIGH IMPEDANCE CARDIAC GATING CABLE (K981190) | GE Medical Systems | 1998-06-30 |
| SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR (K973914) | Sense Technology, Inc. | 1998-06-30 |
| STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR (K981717) | Stryker Instruments | 1998-06-30 |
| HAMMERSMITH ENDOCAVITARY COILS (K981410) | Philips Medical Systems (Cleveland), Inc. | 1998-06-30 |
| SYMPHONY 360 REMOTE CONTROL TABLE (K981227) | Acoma Medical Imaging, Inc. | 1998-06-30 |
| INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING (K981753) | Innovative Technologies , Ltd. | 1998-06-30 |
| LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES (K981172) | Byron Medical | 1998-06-30 |
| FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT (K981194) | Nexa Orthopedics, Inc. | 1998-06-30 |
| AMIGO RT (K981121) | Amigo Mobility Intl., Inc. | 1998-06-30 |
| TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM (K981714) | Acromed Corp. | 1998-06-30 |
| LASETTE LASER SKIN PERFORATOR (K981149) | Cell Robotics, Inc. | 1998-06-29 |
| CHROMOSCAN SCANNING SYSTEM (K980753) | Mehl/Biophile Intl., Inc. | 1998-06-29 |
| SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR (K981362) | Synthes (Usa) | 1998-06-29 |
| DAUM BONE BIOPSY SET (K981320) | Daum Corp. | 1998-06-29 |
| OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 (K982024) | Medical Analysis Systems, Inc. | 1998-06-29 |
| URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 (K981933) | Medical Analysis Systems, Inc. | 1998-06-29 |
| AST/SGOT LIQUID REAGENT - KINETIC METHOD (K981650) | Teco Diagnostics | 1998-06-29 |
| AST (K981843) | Abbott Laboratories | 1998-06-29 |
| QUANTECH MYOGLOBIN ASSAY (K981536) | Hellen Professional Services | 1998-06-29 |
| BIOSTRIDE FREE T4 EIA TEST KIT (K981243) | Biostride Diagnostics, Inc. | 1998-06-29 |
| I-STAT LACTATE TEST (K982071) | I-Stat Corp. | 1998-06-29 |
| ELECSYS CEA ON THE ELECSYS 1010 (K980887) | Boehringer Mannheim Corp. | 1998-06-29 |
| SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (K981872) | Diagnostic Chemicals , Ltd. | 1998-06-29 |
| OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES (K981219) | Enable Medical Corp. | 1998-06-29 |
| GENIE CUP INTEGRATED SCREENING DEVICE (K980836) | Applied Technology Ventures, LLC | 1998-06-29 |
| SURGITRON (K980170) | Ellman Intl., Inc. | 1998-06-29 |
| MANAN BLUNT NEEDLE (K981386) | Manan Medical Products, Inc. | 1998-06-29 |
| HICHEM PHOSPHORUS REAGENT KIT (K981769) | Elan Pharma, Inc. | 1998-06-29 |
| ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY (K981342) | Abbott Laboratories | 1998-06-29 |
| VANTAGE 3.0 INSYNCH (K981291) | Adac Laboratories | 1998-06-29 |
| RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM (K965223) | Endosonics Corp. | 1998-06-29 |
| MODEL 7410 VOYAGER (K974879) | Healthdyne Technologies, Inc. | 1998-06-29 |
| CHOL (K981652) | Abbott Laboratories | 1998-06-29 |
| VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM (K980915) | Valleylab, Inc. | 1998-06-29 |
| MODIFICATION FOR PTA BALLOON CATHETER (K981906) | Cook, Inc. | 1998-06-29 |
| PHYTACARE ALGINATE HYDROGEL WOUND DRESSING (K980132) | Phytatek Laboratories, Inc. | 1998-06-26 |
| PASSPORT 5L-CE MODEL 0998-00-0131XXX (K974178) | Datascope Corp. | 1998-06-26 |
| SILIMED NASAL L SHAPED IMPLANT (K981833) | Silimed, LLC | 1998-06-26 |
| LIFE SUPPORT FOR TRAUMA AND TRANSPORT (K965117) | Northrop Grumman Corp. | 1998-06-26 |
| CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER (K973298) | Cardima, Inc. | 1998-06-26 |
| THALAFIX NATURAL SEA SALT DRESSING (K980779) | Dumex Medical Surgical Products, Ltd. | 1998-06-26 |
| PATHFINDER MOBILE C ARM (K981131) | Acoma Medical Imaging, Inc. | 1998-06-26 |
| RELIANCE LONG STEM FEMORAL COMPONENTS (K980813) | Howmedica, Inc. | 1998-06-26 |
| CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (K964514) | Corpak, Inc. | 1998-06-26 |
| DIALOG DIALYSIS MACHINE (K963440) | B. Braun Medical AG | 1998-06-26 |
| SURGIFLATOR-20 ECU (K981859) | W.O.M. World of Medicine GmbH | 1998-06-26 |
| ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 (K981728) | Alexander Mfg. Co. | 1998-06-26 |
| OSTEOGRAF/N-700 (K981214) | Ceramed Dental, LLC | 1998-06-26 |
| VED VALU- VACUUM ERECTION DEVICE (K980948) | Mission Pharmacal Comp | 1998-06-25 |
| RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) (K981506) | Repro-Med Systems, Inc. | 1998-06-25 |
| POLYSORB SUTURE (K981935) | United States Surgical, A Division of Tyco Healthc | 1998-06-25 |
| BIOSIGN HCG I - ONE STEP PREGNANCY TEST (K981443) | Princeton BioMeditech Corp. | 1998-06-25 |
| CARESIDE URIC ACID (K981604) | Careside, Inc. | 1998-06-25 |
| ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 (K981838) | Unotech Diagnostics, Inc. | 1998-06-25 |
| SPENCO SILICONE GEL SHEET (K981902) | Spenco Medical Corp. | 1998-06-25 |
| CARESIDE ANALYZER (K981610) | Careside, Inc. | 1998-06-25 |
| ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE (K982009) | Scitech Solutions, Inc. | 1998-06-25 |
| WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD (K982097) | Worldwide Medical Technologies, LLC | 1998-06-25 |
| CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3 (K981126) | Ceram Optec, Inc. | 1998-06-25 |
| GC FUJI ORTHO LC (K981461) | GC America, Inc. | 1998-06-25 |
| SMC 28MM CERAMIC FEMORAL HEADS (K981302) | Signal Medical Corp. | 1998-06-25 |
| CHOL (K981476) | Abbott Laboratories | 1998-06-25 |
| MICROCAP (K981114) | Oridion Medical , Ltd. | 1998-06-25 |
| MINRAD DRTS LIGHT SABER SYRINGE (K981140) | Minrad, Inc. | 1998-06-25 |
| BECTON DICKINSON SYRINGES (K980580) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-25 |
| ORTHODONTIC BRACES (K981433) | Midwest Orthodontic Mfg. | 1998-06-25 |
| SYNTHES (USA) RATCHETING DISTRACTOR (K981275) | Synthes (Usa) | 1998-06-25 |
| CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM (K961320) | Buckman Co., Inc. | 1998-06-25 |
| RADIO-PLAST (K981115) | Smith & Nephew, Inc. | 1998-06-25 |
| CLEARPLAN EASY OVULATION TEST (K981271) | Unipath , Ltd. | 1998-06-25 |
| SEMKIN BIPOLAR FORCEP (K974594) | Titan Mfg., Inc. | 1998-06-24 |
| MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 (K981416) | Magna Advanced Technologies, Inc. | 1998-06-24 |
| RAICHEM CO2 REAGENT (K982056) | Reagents Applications, Inc. | 1998-06-24 |
| DRS SYSTEM (K981822) | Professional Distribution Systems, Inc. | 1998-06-24 |
| VENTURI VENTILATOR (K982174) | Cardiopulmonary Corp. | 1998-06-24 |
| RENU MULTIPLUS LUBRICATING & REWETTING DROPS (K980591) | Bausch & Lomb, Inc. | 1998-06-24 |
| STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE (K974735) | Aaron Medical Industries | 1998-06-24 |
| UNIVERSAL DRIVE SYSTEM (K981269) | Linvatec Corp. | 1998-06-24 |
| CUSHING BAYONET, INSULATED BIPOLAR FORCEP (K974595) | Titan Mfg., Inc. | 1998-06-24 |
| CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT (K981779) | Cantor & Silver , Ltd. | 1998-06-24 |
| OLYMPUS CALCIUM ARSENAZO III REAGENT (K982035) | Olympus Diagnostica GmbH | 1998-06-24 |
| SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM (K974417) | Resmed Corp | 1998-06-24 |
| SEMKIN INSULATED BIPOLAR FORCEP (K974593) | Titan Mfg., Inc. | 1998-06-24 |
| PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA (K981265) | Hewlett-Packard Co. | 1998-06-23 |
| POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER (K982127) | Porous Media Corp. | 1998-06-23 |
| PURESPERM (K980814) | Nidacon International AB | 1998-06-23 |
| AUTOMATED CORNEAL TREPHINE (K981063) | Laser Center Dev. Corp. | 1998-06-23 |
| CARESIDE TOTAL BILIRUBIN (K981588) | Careside, Inc. | 1998-06-23 |
| TURBOSONICS LIMITED REUSE ULTRASONIC TIP (K981103) | Alcon Laboratories | 1998-06-23 |
| OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) (K981252) | Alden Optical Labs., Inc. | 1998-06-23 |
| SOLOSITE GEL CONFORMABLE DRESSING (K981150) | Smith & Nephew, Inc. | 1998-06-22 |
| HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES (K981893) | M.R.G. Industries Sdn. Bhd. | 1998-06-22 |
| O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 (K981724) | Medtrex, Inc. | 1998-06-22 |
| KSEA CALCUSON (K973251) | KARL STORZ Endoscopy-America, Inc. | 1998-06-22 |