| MYCOPLASMA IGG ELISA TEST SYSTEM (K971393) | Immunoprobe, Inc. | 1997-07-14 |
| FG INFUSION CATHETER (K971306) | Cordis Neurovascular, Inc. | 1997-07-14 |
| ALCON CONTACT LENS CASE (K971618) | Alcon Laboratories | 1997-07-14 |
| INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (K972330) | Oxis Intl., Inc. | 1997-07-14 |
| TARGOBEAM (K970819) | Ferguson Medical | 1997-07-14 |
| THYROGLOBULIN ASSAY SYSTEM (K972190) | American Laboratory Products Co., Ltd. | 1997-07-14 |
| FACTOR DEFICIENT PLASMAS - FACTOR XI (11) (K972286) | Universal Reagents, Inc. | 1997-07-14 |
| N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT (K965100) | Crestat Diagnostics, Inc. | 1997-07-14 |
| SUNGLASSES (K971385) | Kosway Industries Co., Ltd. | 1997-07-14 |
| VISTA BRITE TIP CATHETERS (K971572) | Cordis Corp. | 1997-07-14 |
| PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE (K971945) | Tillotson Healthcare Corp. | 1997-07-14 |
| N-ASSAY TIA C1-INACTIVATOR TEST KIT (K965024) | Crestat Diagnostics, Inc. | 1997-07-14 |
| CELL ROBOTICS ER: YAG SURGICAL LASER (K970461) | Cell Robotics, Inc. | 1997-07-11 |
| MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM (K971105) | Avecor Cardiovascular, Inc. | 1997-07-11 |
| ALLEN, ULTRA AND SMART SOCKETS (K971988) | Allen Medical Systems, Inc. | 1997-07-11 |
| FAR-EAST SHOE COVERS (K971191) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| FAR-EAST BOUFFANT CAPS (K970988) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| FLOTEC OXYSAVRR (S) (K970371) | Flotec, Inc. | 1997-07-10 |
| SOMNITOR 32K SLEEP ACTIVITY MONITOR (K965079) | Neurim Pharmaceuticals, Ltd. | 1997-07-10 |
| SOMA 900 TRANSPORT BED (K971546) | Nova Technologies, Inc. | 1997-07-10 |
| TRANS VAGINAL NEEDLE GUIDE (K971722) | Protek Medical Products, Inc. | 1997-07-10 |
| PRO CHECK DIGITAL PACIFIER THERMOMETER (K972259) | Micro Weiss Electronics | 1997-07-10 |
| ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K964190) | Biotronik, Inc. | 1997-07-10 |
| POST-STOP EPISTAXIS CATHETER (K972078) | Boston Medical Products, Inc. | 1997-07-10 |
| MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE (K970051) | Smith and Nephew Donjoy, Inc. | 1997-07-10 |
| ACTA OEM MODULE (K972006) | Interactive Consulting, Inc. | 1997-07-10 |
| HEADLOC CERAMIC HEAD (K971426) | Ortho Development Corp. | 1997-07-09 |
| OSTEO COMPRESSION HIP SCREW SYSTEM (K971654) | Osteonics Corp. | 1997-07-09 |
| ASC BALANCE MIDDLEWEIGHT GUIDE WIRE (K971815) | Guidant Corp. | 1997-07-09 |
| OSTEONICS ALUMINA C-TAPER HEAD (K971409) | Osteonics Corp. | 1997-07-09 |
| ESCORT II CLINICAL THERMOMETRY MODULE (CTM) (K970011) | Medical Data Electronics | 1997-07-09 |
| NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES (K971194) | Nihon Kohden America, Inc. | 1997-07-09 |
| EPITECH ISLAND DRESSINGS (K971337) | Rynel, Ltd. Inc. | 1997-07-09 |
| HEADLOC CERAMIC FEMORAL HEADS (K971435) | Ortho Development Corp. | 1997-07-09 |
| 34MM SCARF THREAD-HEAD(TM) SCREW (K971068) | Landos, Inc. | 1997-07-09 |
| POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES (K971381) | Allegiance Healthcare Corp. | 1997-07-09 |
| SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER (K971404) | Schwartz Electro-Optics, Inc. | 1997-07-09 |
| DISPOSABLE PATIENT RETURN ELECTRODE (K972269) | Erbe USA, Inc. | 1997-07-09 |
| AMS MAINSTAY UROLOGIC BONE ANCHOR (K971332) | American Medical Systems, Inc. | 1997-07-09 |
| SP4044 & SP4055 LUX MODULES (K972026) | Satelec | 1997-07-09 |
| SCARF THREAD-HEAD (TM) HEAD SCREW (K971070) | Landos, Inc. | 1997-07-09 |
| THERAPLAN PLUS VERSION 1.2 (K970236) | Theratronics, Inc. | 1997-07-09 |
| INTERSEAL ACETABULAR SCREW HOLE PLUG (K971429) | Wrightmedicaltechnologyinc | 1997-07-09 |
| INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (K971079) | Interlogics, Inc. | 1997-07-09 |
| RPI DUAL PORT IRRIGATION ADAPTER (K964920) | Ridge Products, Inc. | 1997-07-09 |
| OSTEO COMPRESSION CONDYLE SCREW SYSTEM (K971321) | Osteonics Corp. | 1997-07-09 |
| BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER (K971700) | Biosound, Inc. | 1997-07-09 |
| BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM (K971358) | Arthrex, Inc. | 1997-07-09 |
| TWIST-OFF (TM) SCREW (K971069) | Landos, Inc. | 1997-07-09 |
| KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS (K971550) | Howmedica Corp. | 1997-07-08 |
| TBD (K972273) | Megadyne Medical Products, Inc. | 1997-07-08 |
| RMI HEMOCONCENTRATOR PREFERENCE PACK (K970739) | Research Medical, Inc. | 1997-07-08 |
| FAR-EAST BARRIER GOWNS (K971702) | Far East Science & Technology Development Co., Ltd. | 1997-07-08 |
| QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS (K972146) | Consolidated Technologies, Inc. | 1997-07-08 |
| DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) (K971342) | Disk Whisk, Inc. | 1997-07-08 |
| KAR (K961732) | Landos, Inc. | 1997-07-08 |
| X-RAY ASSIST BAR (K972000) | Ralph Lindel, D.C. | 1997-07-08 |
| NASAL AIRWAY SPLINT (K972092) | Boston Medical Products, Inc. | 1997-07-08 |
| NICAS(TM) ELECTRODE (K972001) | Ni Medical | 1997-07-08 |
| DOYLE COMBO NASAL AIRWAY SPLINT (K972151) | Boston Medical Products, Inc. | 1997-07-07 |
| EPILIGHT HAIR REMOVAL SYSTEM (K963249) | Esc Medical Systems , Ltd. | 1997-07-07 |
| BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST (K971349) | Princeton BioMeditech Corp. | 1997-07-07 |
| PRECINORM TDM CONTROLS (K971060) | Boehringer Mannheim Corp. | 1997-07-07 |
| IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (K971473) | M-Pact Worldwide Management Corp. | 1997-07-07 |
| SCLERAL SHELL (K970320) | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 |
| OCULAR CONFORMER (K970319) | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 |
| CMS CRYOLITE (K970995) | Cryomedical Sciences, Inc. | 1997-07-07 |
| DADE TRU-LIQUID BILIRUBIN CONTROL (K972287) | Dade Intl., Inc. | 1997-07-07 |
| ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE (K971302) | Ethicon Endo-Surgery, Inc. | 1997-07-07 |
| CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE (K961734) | Terumo Medical Corp. | 1997-07-07 |
| MANUAL RESUSCITATOR (K963848) | Owens-Brigam Medical Co. | 1997-07-07 |
| OCULAR CONFORMER (K970318) | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| SCLERAL SHELL (K970327) | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| LEVO ACTIVE-EASY LAE (K971873) | Levo USA | 1997-07-03 |
| MEDRAD FLEX INTERFACE DEVICE (K971380) | Medrad, Inc. | 1997-07-03 |
| SHARPS CONTAINER (K970398) | Custom Medical Plastics, Inc. | 1997-07-03 |
| INTRUDER (K972038) | The Buzzz Corp. | 1997-07-03 |
| UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (K972068) | Pharmacia, Inc. | 1997-07-03 |
| INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO (K965179) | Neo Imagery Technologies, Inc. | 1997-07-03 |
| ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (K965230) | Abbott Mfg., Inc. | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (K971865) | Alexander Mfg. Co. | 1997-07-03 |
| SHARPS CONTAINER (K970383) | Custom Medical Plastics, Inc. | 1997-07-03 |
| MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL (K964172) | Medtronic Vascular | 1997-07-03 |
| PEFECT SHOT (K972019) | International Imaging Electronics | 1997-07-03 |
| UNIJECT EXAMINATION GLOVES (K970191) | Uniject Gloves , Ltd. | 1997-07-03 |
| 2008H ON LINE CLEARANCE MONITOR (K961465) | Fresenius USA, Inc. | 1997-07-03 |
| CUSTOM NASAL SPLINT (K972082) | Boston Medical Products, Inc. | 1997-07-03 |
| ONE STEP MORPHINE CARD TEST (K970579) | Teco Diagnostics | 1997-07-03 |
| VERSION 4 OPERATING SYSTEM SOFTWARE (K971279) | Hitachi Medical Systems America, Inc. | 1997-07-03 |
| AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971635) | Oxoid , Ltd. | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 (K972089) | Alexander Mfg. Co. | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (K972084) | Alexander Mfg. Co. | 1997-07-03 |
| PROWLER (K972037) | The Buzzz Corp. | 1997-07-03 |
| MS401097-17,MS722-K,MS720,MS721,MS722 (K962767) | Alexander Mfg. Co. | 1997-07-03 |
| ONE STEP MARIJUANA CARD TEST (K970548) | Teco Diagnostics | 1997-07-03 |
| BIO-ESTHETIC INDIRECT ABUTMENT (K970073) | Steri-Oss, Inc. | 1997-07-03 |
| SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES (K971666) | Sj Medical Products (M) Sdn Bhd | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010 (K971866) | Alexander Mfg. Co. | 1997-07-03 |
| PURE COMPANY FLUID DELIVERY SYSTEM (K971278) | Pure Co. | 1997-07-03 |
| STEALTH (K972036) | The Buzzz Corp. | 1997-07-03 |