| OSTEONICS ACETABULAR WEDGE SYSTEM (K971422) | Osteonics Corp. | 1997-05-22 |
| DSL ACTIVE T4 EIA (K971269) | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
| INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES (K970706) | Sulzer Orthopedics, Inc. | 1997-05-22 |
| DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE (K970758) | Howmedica Corp. | 1997-05-22 |
| PROSPORE II (K971430) | Raven Biological Laboratories, Inc. | 1997-05-22 |
| CRYSTAL-EEG MODEL 10 (MODEL 10) (K970672) | Cleveland Medical Devices, Inc. | 1997-05-22 |
| SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING (K971613) | Technical Products, Inc. | 1997-05-22 |
| SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL (K971534) | Beckman | 1997-05-21 |
| HYCOR ALLERGEN DISC (K965094) | Hycor Biomedical, Inc. | 1997-05-21 |
| FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS (K971164) | Aspect Vision Care, Ltd. | 1997-05-21 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT (K964635) | Nichols Institute Diagnostics | 1997-05-21 |
| SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT (K970919) | Beckman Instruments, Inc. | 1997-05-21 |
| PAN (CHIBA ASPIRATING NEEDLE) (K970872) | Gallini Intl., Inc. | 1997-05-21 |
| SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K963254) | Boston Scientific Corp | 1997-05-21 |
| TENOSCOPE (K970642) | Luxtec Corp. | 1997-05-21 |
| ANCA COMBI DIAGNOSTIC TEST KIT (K965133) | The Binding Site, Ltd. | 1997-05-21 |
| PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS (K971174) | Playtex, Inc. | 1997-05-21 |
| UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) (K964329) | Richard Wolf Medical Instruments Corp. | 1997-05-21 |
| ROCHE COBAS AMPLICOR ANALYZER (K964506) | Roche Molecular Systems, Inc. | 1997-05-21 |
| FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K971049) | Aspect Vision Care, Ltd. | 1997-05-21 |
| TR NEEDLE (K970871) | Gallini Intl., Inc. | 1997-05-21 |
| CEDIA DIGOXIN II (K970883) | Boehringer Mannheim Corp. | 1997-05-21 |
| DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM (K964922) | Althin Medical AB an Affiliate of Baxter Intl | 1997-05-21 |
| CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID (K964551) | Scimed Life Systems, Inc. | 1997-05-21 |
| VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (K964978) | Quinton, Inc. | 1997-05-21 |
| 800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES (K970948) | Laserscope | 1997-05-21 |
| ACE HDL-C REAGENT (K971526) | Schiapparelli Biosystems, Inc. | 1997-05-21 |
| FIF TM (K970189) | Panbio, Inc. | 1997-05-21 |
| ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) (K970875) | American Medical Devices, Inc. | 1997-05-20 |
| RADIUS PTCA GUIDEWIRE (K970466) | Radius Medical Technologies, Inc. | 1997-05-20 |
| ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (K970873) | American Medical Devices, Inc. | 1997-05-20 |
| SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR (K970999) | Sony Medical Systems | 1997-05-20 |
| UROSTYM (K962009) | Laborie Medical Technologies, Ltd. | 1997-05-20 |
| HOWTEK 960 (K970908) | Howtek, Inc. | 1997-05-20 |
| OUR ROTATING GAMMA SYSTEM (K970647) | Our Scientific Intl., Inc. | 1997-05-20 |
| SCOPETEX(TM) (K945590) | Smith Helms Mulliss & Moore, L.L.P. | 1997-05-20 |
| JELBOND-PDF (K971574) | J.F. Jelenko & Co., Inc. | 1997-05-20 |
| PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK) (K971515) | Biomed Devices Corp. | 1997-05-20 |
| EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (K964702) | Euclid Systems Corp. | 1997-05-20 |
| LOCKING STYLET 2 (K970690) | Cook Pacemaker Corp. | 1997-05-20 |
| PROSPORE (K971432) | Raven Biological Laboratories, Inc. | 1997-05-20 |
| SAFE-T-CLAMP (K971277) | Talon Medical, Ltd. | 1997-05-20 |
| VISTA SINGLE CHIP VIDEO CAMERA (K971373) | Vista Medical Technologies, Inc. | 1997-05-20 |
| ULTRAFLEX DIAMOND (K962899) | Boston Scientific Corp | 1997-05-20 |
| UMI X-RAY FILM CASSETTE (K971431) | Umi Intl. | 1997-05-20 |
| JEL-71 PDF (K971292) | J.F. Jelenko & Co., Inc. | 1997-05-20 |
| 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER (K964868) | Micro Therapeutics, Inc. | 1997-05-20 |
| CLARUS MODEL 5197 SIGHTLITE (K971455) | Clarus Medical Systems, Inc. | 1997-05-20 |
| ZOLL AUTOCLAVABLE INTERNAL HANDLES (K963781) | Zoll Medical Corp | 1997-05-20 |
| BC THROMBIN REAGENT (K970645) | Behring Diagnostics, Inc. | 1997-05-19 |
| GALILEO HALLEY (K970703) | Biosound Esaote, Inc. | 1997-05-19 |
| VIEWPOINT - 3.0 SOFTWARE (K970604) | Philips Medical Systems (Cleveland), Inc. | 1997-05-19 |
| LUMBAR DRAINAGE ACCESSORY KIT (K970658) | Integra Neurocare, LLC | 1997-05-19 |
| WHITE RIVER MINI MANUAL BREAST PUMP (K971231) | White River Concepts | 1997-05-19 |
| MEGA ME 3000 PROFESSIONAL MUSCLE TESTER (K963202) | Mega Electronics , Ltd. | 1997-05-19 |
| KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) (K962753) | Biomedical Implant Technology, Inc. | 1997-05-19 |
| FREEDOM TRAVELLER (K964825) | Impact Case Technologies, Inc. | 1997-05-19 |
| GRASS BRAINWAVE SOFTWARE (K970951) | Astro-Med, Inc. | 1997-05-19 |
| DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER (K970659) | Telediagnostic Systems, Inc. | 1997-05-16 |
| SYNCHRON SYSTEMS THYROXINE REAGENT (K971203) | Beckman Instruments, Inc. | 1997-05-16 |
| FLEXICAIR EXLIPSE PLUS (K970295) | Hill-Rom, Inc. | 1997-05-16 |
| MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (K953647) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-05-16 |
| TM MICRO-CATHETERS (K971124) | Xomed, Inc. | 1997-05-16 |
| HERO 642 (K970649) | Micro-Mega | 1997-05-16 |
| MANAN V.S. ACCESS NEEDLE/SET (K963767) | Manan Medical Products, Inc. | 1997-05-16 |
| IMMULITE VITAMIN B12 (LKVB1,LKVB5) (K971177) | Diagnostic Products Corp. | 1997-05-16 |
| CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM (K970362) | Apex Metal, Inc. | 1997-05-16 |
| ALP REAGENT SET (K971463) | Carolina Liquid Chemistries Corp. | 1997-05-16 |
| DSL ESTRONE-SULFATE RIA (K970915) | Diagnostic Systems Laboratories, Inc. | 1997-05-16 |
| OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (K970716) | Opticon Medical, Inc. | 1997-05-16 |
| BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000) (K964605) | Thermoscan, Inc. | 1997-05-16 |
| TOTAL PROTEIN OR TP (K971524) | Carolina Liquid Chemistries Corp. | 1997-05-16 |
| DHD EMERALD PRODUCT (K970596) | Dhd Diemolding Healthcare Div. | 1997-05-16 |
| AMBU SPUR NEONATE (K964584) | Ambu, Inc. | 1997-05-15 |
| HEWLETT-PACKARD CENTRALVUE SOFTWARE (K964832) | Hewlett-Packard Co. | 1997-05-15 |
| P.H.D. - PERSONAL HEART DEVICE MODEL 5258 (K963904) | Heart Alert, Inc. | 1997-05-15 |
| 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES (K971148) | Cardiotronics Systems, Inc. | 1997-05-15 |
| QUANTUM 3080SP SURGICAL TABLE (K971390) | STERIS Corporation | 1997-05-15 |
| NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K (K970639) | Medicotest, Inc. | 1997-05-15 |
| FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (K964518) | Daig Corp. | 1997-05-14 |
| MODEL 405T WITH ETCO2 OPTION (K964961) | Ivy Biomedical Systems, Inc. | 1997-05-14 |
| MYERSON'S ECONOMY DENTURE BASE MATERIAL (K970522) | Austenal, Inc. | 1997-05-14 |
| NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR (K964869) | The Magstim Company , Ltd. | 1997-05-14 |
| ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) (K970787) | Alexander Mfg. Co. | 1997-05-14 |
| TENOSNARE (K970562) | Luxtec Corp. | 1997-05-14 |
| D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES (K965052) | Wesley Jessen Corp. | 1997-05-14 |
| SCANRITE DFS (K970850) | Scanrite Systems | 1997-05-14 |
| B-350 CEILING MOUNTED C-POSITIONER (K970947) | Omega Medical Imaging, Inc. | 1997-05-14 |
| REST X SYSTEM (K970428) | Restxsys | 1997-05-14 |
| PHILIPS INTEGRIS H5000 (K971365) | Philips Medical Systems North America, Inc. | 1997-05-14 |
| MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (K971452) | Siemens Medical Solutions USA, Inc. | 1997-05-14 |
| QUIKPAC II ONE STEP AMPHETAMINE TEST (K971109) | Drial Consultants, Inc. | 1997-05-14 |
| CEDIA DIGOXIN (K970881) | Boehringer Mannheim Corp. | 1997-05-14 |
| ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) (K970784) | Alexander Mfg. Co. | 1997-05-14 |
| MODEL 1700, HYDRO PREP (K970694) | Physiometrix, Inc. | 1997-05-14 |
| ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (K970799) | Alexander Mfg. Co. | 1997-05-14 |
| ODYSSEY I DENTAL WATER UNIT (K964796) | Germiphene Corp. | 1997-05-14 |
| CALTAG CAL-LYSE (K965232) | Caltag Laboratories, Inc. | 1997-05-14 |
| EPISTAXIS NASAL PACK (K971000) | Invotec International, Inc. | 1997-05-14 |
| SUNGLASSES (K971412) | Team Chien Industrial Co., Ltd. | 1997-05-13 |