| SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT (K964373) | 3M Healthcare | 1997-06-18 |
| UNIVERSAL DRIVE SYSTEM (K971059) | Linvatec Corp. | 1997-06-18 |
| QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 (K972080) | Consolidated Technologies, Inc. | 1997-06-18 |
| CREA OR CREATININE (K971908) | Carolina Liquid Chemistries Corp. | 1997-06-17 |
| 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, (K963920) | Arrow Intl., Inc. | 1997-06-17 |
| KEY CHAIN EMERGENCY AIRWAY (K962312) | Ffrench Pocket Emergency Airway, Inc. | 1997-06-17 |
| OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM (K965041) | Ohmeda Medical | 1997-06-17 |
| DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES (K971065) | Xintec Corporation | 1997-06-17 |
| BLOOD FLOW ANALYZER (K970887) | Paradigm Medical Industries, Inc. | 1997-06-17 |
| MICRODL DIARYCARD SPIROMETER (K965042) | Micro Direct, Inc. | 1997-06-17 |
| HEARTPORT ENDOARTERIAL RETURN CANNULA (K971291) | Heartport, Inc. | 1997-06-17 |
| COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 (K971428) | Pacific Hemostasis | 1997-06-17 |
| DANAVOX MODELS 163/162 BTE (K971032) | Gn Danavox, Inc. | 1997-06-17 |
| TINAQUANT RHEUMATOID FACTOR ASSAY (K971379) | Boehringer Mannheim Corp. | 1997-06-17 |
| STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES (K971439) | Storz Instrument Co. | 1997-06-17 |
| PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS (K970992) | Premier Dental Products Co. | 1997-06-17 |
| AUDALLION III HEARING SYSTEM (K971031) | Gn Danavox, Inc. | 1997-06-17 |
| BUN (K971967) | Carolina Liquid Chemistries Corp. | 1997-06-17 |
| ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) (K964818) | Laserscope | 1997-06-17 |
| SOFTSCAN (K971024) | Sahar Technologies, Inc. | 1997-06-17 |
| DYNABITE HOT GI BIOPSY FORCEPS (K970083) | Portlyn Corp. | 1997-06-17 |
| VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (K971449) | Becton Dickinson Vacutainer Systems | 1997-06-17 |
| DIASCREEN REAGENT STRIPS (K971976) | Dia-Screen Corp. | 1997-06-17 |
| TOTAL THROXINE MICROPLATE EIA(225-300) (K971709) | Monobind | 1997-06-16 |
| ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS (K971053) | International Medical Products, Inc. | 1997-06-16 |
| ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS (K972004) | Alko Diagnostic Corp. | 1997-06-16 |
| ELECSYS CEA ASSAY (K964368) | Boehringer Mannheim Corp. | 1997-06-16 |
| DATEX ENGSTOM MANUAL RESUSCITATOR (K970991) | Promedic, Inc. | 1997-06-16 |
| LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR (K971162) | Genzyme Corp. | 1997-06-16 |
| NIL - POWDER-FREE LATEX EXAMINATION GLOVES (K961634) | Hl Rubber Products Sdn Bhd | 1997-06-16 |
| POWDER-FREE LATEX EXAMINATION GLOVES (K964724) | Pwa Industries Sdn. Bhd. | 1997-06-16 |
| HIGH RANGE PEROXIDE TEST STRIP (K964264) | Integrated Biomedical Technology, Inc. | 1997-06-16 |
| GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 (K965044) | Elscint, Inc. | 1997-06-16 |
| LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) (K971952) | Bio-Rad | 1997-06-16 |
| SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (K971467) | Carolina Liquid Chemistries Corp. | 1997-06-16 |
| ACTIVE TESTOSTERONE EIA (DSL-10-4000) (K971823) | Diagnostic Systems Laboratories, Inc. | 1997-06-16 |
| ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE (K970131) | C.L. Mcintosh & Assoc., Inc. | 1997-06-16 |
| GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER (K971276) | Bayer Corp. | 1997-06-16 |
| TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER (K971111) | Tri-Tech, Inc. | 1997-06-16 |
| SPECIALITY URINE 1,2 (K971405) | Chiron Diagnostics Corp. | 1997-06-16 |
| SNT DISPOSABLE BIOPSY NEEDLE (K971247) | Surgical Navigation Technologies, Inc. | 1997-06-16 |
| TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (K971779) | Monobind | 1997-06-16 |
| MYCOPLASMA IGG ELISA TEST SYSTEM (K970150) | Zeus Scientific, Inc. | 1997-06-16 |
| N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K971190) | Genzyme Corp. | 1997-06-16 |
| ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT (K971902) | Roche Diagnostic Systems, Inc. | 1997-06-16 |
| N-ASSAY TIA TRANSFERRIN TEST KIT (K964295) | Crestat Diagnostics, Inc. | 1997-06-16 |
| C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET (K971274) | Fresenius AG | 1997-06-13 |
| AMO DIPLOMAX/OPSYS CONSOLE (K971186) | Allergan, Inc. | 1997-06-13 |
| VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS (K971253) | Smith & Nephew, Inc. | 1997-06-13 |
| SIMS HYPERINFLATION BAG SYSTEM (K970785) | Sims | 1997-06-13 |
| MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM (K970964) | International Imaging Electronics | 1997-06-13 |
| DEVILBISS 8650D (K963349) | Devilbiss Health Care, Inc. | 1997-06-13 |
| INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) (K970959) | Instrumentation Industries, Inc. | 1997-06-13 |
| NYLON COATED SPECULA (K925501) | Zinnanti Surgical Instruments, Inc. | 1997-06-13 |
| LXN FRUCTOSAMINE TEST SYSTEM (K962597) | Lxn Corp. | 1997-06-13 |
| AUTIMO (K971001) | Medizintechnik, GmbH | 1997-06-13 |
| OPTIM-EYES 450 (K971875) | Taylor/Fox Enterprises, LLC | 1997-06-13 |
| PEAK FLOW METER (K970507) | Intl. Medical, Inc. | 1997-06-13 |
| OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS (K971054) | Siemens Medical Solutions USA, Inc. | 1997-06-13 |
| THERAPAX SXT 150 (K971074) | Pantak, Inc. | 1997-06-13 |
| ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE (K971805) | Aaron Medical Industries | 1997-06-13 |
| SUNGLASSES (NON-PRESCRIPTION) (K971707) | Niko Sunglasses Corp. | 1997-06-13 |
| DUALINE 400 CIC (K971158) | Bernafon-Maico, Inc. | 1997-06-13 |
| SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC) (K971087) | W.J. Byrnes & Co. of Los Angeles, Inc. | 1997-06-13 |
| PERITONEAL/CARDIAC CATHETER (K970983) | Integra Neurocare, LLC | 1997-06-13 |
| VERIDOSE DIODES (K964785) | Victoreen, Inc. | 1997-06-13 |
| N/A (K970590) | North American Technical Services Corp. | 1997-06-13 |
| HBF-1000 OMRON BODY COMPOSITION ANALYZER (K963575) | Omron Healthcare, Inc. | 1997-06-13 |
| GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE (K971115) | Protek Medical Products, Inc. | 1997-06-13 |
| ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K964507) | Roche Molecular Systems, Inc. | 1997-06-13 |
| BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS (K961787) | Hologic, Inc. | 1997-06-13 |
| MITAYA ALUMINUM INTERSPACED X-RAY GRID (K964025) | X-Ray Accessory Corp. | 1997-06-13 |
| N/A (K970592) | North American Technical Services Corp. | 1997-06-13 |
| AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC (K971399) | General Hearing Instruments, Inc. | 1997-06-13 |
| CARDIOMATCH (K970970) | Focus Medical SA | 1997-06-13 |
| MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER (K961779) | Avion Medical Products, Inc. | 1997-06-13 |
| SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT (K971230) | Innerdyne, Inc. | 1997-06-13 |
| ASPISAFE GASTRIC TUBE (K961711) | B.Braun Medical, Inc. | 1997-06-11 |
| OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (K971061) | Opportunity, Inc. | 1997-06-11 |
| SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT (K971505) | Beckman Instruments, Inc. | 1997-06-11 |
| CB ERBIUM/2.94(TM) ER:YAG LASER (K970934) | Continuum Biomedical, Inc. | 1997-06-11 |
| BIO-GIDE RESORBABLE BILAYER MEMBRANE (K960724) | Geistlich-Pharma | 1997-06-11 |
| ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM (K970955) | Acromed Corp. | 1997-06-11 |
| ACCUTEST HCG-URINE (K971886) | Unotech Diagnostics, Inc. | 1997-06-11 |
| PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR (K971334) | Pilling Weck Group | 1997-06-11 |
| OLYMPUS CK-MB REAGENT (K971817) | Olympus America, Inc. | 1997-06-11 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT (K964842) | Beckman Instruments, Inc. | 1997-06-11 |
| N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971713) | Bayer Corp. | 1997-06-11 |
| 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES (K971444) | 3M Medical Products Group | 1997-06-11 |
| LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) (K971954) | Bio-Rad | 1997-06-11 |
| KANEDA SR ANTERIOR SPINAL SYSTEM (K971248) | Acromed Corp. | 1997-06-11 |
| VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST (K971674) | Aaron Medical Industries | 1997-06-11 |
| DURATION STABILIZED UHMWPE KNEE COMPONENTS (K965173) | Howmedica Corp. | 1997-06-11 |
| ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA (K970177) | Immco Diagnostics, Inc. | 1997-06-11 |
| WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM (K963653) | Wallach Surgical Devices, Inc. | 1997-06-11 |
| DURATION STABILIZED UHMWPE (K963612) | Howmedica Corp. | 1997-06-11 |
| CLYDE CORONARY GUIDEWIRE (K970528) | Schneider (Europe) GmbH | 1997-06-10 |
| BREATH TAKER (K971887) | Hofa, LLC | 1997-06-10 |
| SOLOS 10MM OPERATING LAPAROSCOPE (K970917) | Woodbine Optical Corp. | 1997-06-10 |
| HOTMAN (K952172) | Hemo Sapiens, Inc. | 1997-06-10 |