| ACUITY CENTRAL STATION (K972121) | Protocol Systems, Inc. | 1997-11-07 |
| SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (K970081) | Cathay Consolidated, Inc. | 1997-11-07 |
| GESCO PER-Q-CATH MIDLINE CATHETERS (K971991) | Bard Access Systems, Inc. | 1997-11-07 |
| STERI-OSS UNTIL IMPLANT CEMENT (K972965) | Steri-Oss, Inc. | 1997-11-07 |
| KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (K973546) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-11-07 |
| PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) (K973058) | Sri Johani Sdn. Bhd. | 1997-11-07 |
| D.O.R.C. SOLUX LIGHT SOURCE (K973757) | Dutch Ophthalmic USA, Inc. | 1997-11-07 |
| LOW PROFILE FEEDING SET ACCESSORY (K971757) | Applied Medical Technologies | 1997-11-07 |
| ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE (K973301) | Retractable Technologies, Inc. | 1997-11-07 |
| O2 BOOT (K971507) | Gwr Medical, Llp | 1997-11-07 |
| MICRO21 WITH WBC ESTIMATE (K973050) | Triangle Biomedical Sciences, Inc. | 1997-11-07 |
| UNCOATED ELECTROSURGICAL ELECTRODE (K973346) | Megadyne Medical Products, Inc. | 1997-11-07 |
| VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR (K971836) | CooperSurgical, Inc. | 1997-11-07 |
| FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE (K962554) | Abbott Laboratories | 1997-11-07 |
| KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING (K973068) | Karl Storz Endoskop GmbH | 1997-11-07 |
| IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (K973502) | Implantech Associates, Inc. | 1997-11-07 |
| DURALASTIC ANATOMICAL CHIN IMPLANTS (K973575) | Hanson Medical, Inc. | 1997-11-07 |
| LIFEPAK 300 (K962359) | Physio-Control Corp. | 1997-11-06 |
| BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT (K972203) | Allied Healthcare Products, Inc. | 1997-11-06 |
| DADE TRU-LIQUID CARDIAC CONTROL (K973974) | Dade Intl., Inc. | 1997-11-06 |
| (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH (K962473) | Data Critical Corporation | 1997-11-06 |
| QUEST VESSEL CATHETER (K971928) | Quest Medical, Inc. | 1997-11-06 |
| POLY (VINYL) EXAM GLOVE, POWDER-FREE (K972624) | Copioumed Intl., Inc. | 1997-11-06 |
| ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR (K972927) | Richard Wolf Medical Instruments Corp. | 1997-11-06 |
| DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER (K973007) | Datascope Corp. | 1997-11-06 |
| STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM (K973215) | Laurus Medical Corp. | 1997-11-06 |
| OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED (K973134) | Omnigrace , Ltd. | 1997-11-06 |
| MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K973551) | Pwa Industries Sdn. Bhd. | 1997-11-06 |
| MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) (K965022) | Dako Corp. | 1997-11-06 |
| CONVEEN EASICATH SET (K973070) | Coloplast Corp. | 1997-11-06 |
| VITAPEX PRE-LOADED DENTAL SYRINGE (K973667) | Neodental Chemical Products Co., Ltd. | 1997-11-06 |
| FINGERPRINT DRUG SCREENING DEVICE (K973726) | Applied Technology Ventures, LLC | 1997-11-06 |
| CARIES STAIN (K973200) | Parkell, Inc. | 1997-11-06 |
| INVOTEC EAR TAMPON (WICK) W/STRING (K973578) | Invotec International, Inc. | 1997-11-06 |
| 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K972962) | 3M Company | 1997-11-06 |
| ACE PHENOBARBITAL REAGENT/AED CALIBRATORS (K973536) | Schiapparelli Biosystems, Inc. | 1997-11-06 |
| POWERTREK INSTRUMENTS (K972057) | Medtrek Corp. | 1997-11-05 |
| VITALMIX PLUS EMPTY I.V. CONTAINER (K972464) | Pacific Device, Inc. | 1997-11-05 |
| PASCO MIC AND MIC/ID PANELS (K973695) | Pasco Laboratories, Inc. | 1997-11-05 |
| SERAQUEST VZV IGG (K972295) | Quest Intl., Inc. | 1997-11-05 |
| DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) (K973081) | Howtek, Inc. | 1997-11-05 |
| ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO (K970857) | Davis & Geck, Inc. | 1997-11-05 |
| MICRO ELECTRODES (K971838) | CooperSurgical, Inc. | 1997-11-05 |
| ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE (K973158) | Oratec Interventions, Inc. | 1997-11-05 |
| AVE BRIDGE STENT SYSTEM (K971295) | Arterial Vascular Engineering, Inc. | 1997-11-05 |
| L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM (K973079) | Acuson Corp. | 1997-11-05 |
| MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM (K973012) | MDC Research , Ltd. | 1997-11-05 |
| POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES (K972090) | Shen Wei (Usa), Inc. | 1997-11-05 |
| STELKAST BIPOLAR SYSTEM (K972961) | Stelkast Company | 1997-11-04 |
| PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (K953893) | Biomedical Sensors, Inc. | 1997-11-04 |
| THERAPIK (K964397) | The Jenex Corporation | 1997-11-04 |
| NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) (K973533) | Nidek, Inc. | 1997-11-04 |
| IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS (K972903) | Imatron, Inc. | 1997-11-04 |
| TRINITY DVT SYSTEM (K963957) | Delphi Consulting Group | 1997-11-04 |
| HYDROCHECK MICRO FILTER (K970488) | White River Concepts | 1997-11-04 |
| VISTA EYESHOWER (K971134) | John Branch | 1997-11-04 |
| NIDEK HANDY (K973218) | Nidek, Inc. | 1997-11-04 |
| PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) (K973972) | Perfect Ear | 1997-11-04 |
| Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (K974000) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER (K972518) | Cordis Neurovascular, Inc. | 1997-11-04 |
| IMX CA 125 (K964185) | Abbott Diagnostics | 1997-11-04 |
| IL TEST APTT-SP (K973306) | Instrumentation Laboratory CO | 1997-11-04 |
| OSOM CARD HCG-URINE TEST (K973879) | Wyntek Diagnostics, Inc. | 1997-11-04 |
| TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) (K973226) | Heinz Kurz GmbH Medizintechnik | 1997-11-04 |
| AXSYM CA 125 (K964020) | Abbott Laboratories | 1997-11-04 |
| RODENSTOCK LASER SLITLAMP (K973220) | G. Rodenstock Instrumente GmbH | 1997-11-04 |
| SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (K973933) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| MUMPS IGG ELISA TESTY (K971857) | Gull Laboratories, Inc. | 1997-11-04 |
| IL TEST D-DIMER (K972696) | Instrumentation Laboratory CO | 1997-11-04 |
| MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER (K973665) | Magnatone Hearing Aid Corp. | 1997-11-04 |
| CONTROL SYRINGE (K972655) | Medical Specialties Intl., Inc. | 1997-11-04 |
| ELECSYS CALLCHECK DIGOXIN (K973973) | Boehringer Mannheim Corp. | 1997-11-04 |
| ACE PHENYTOIN REAGENT, AED CALIBRATORS (K973414) | Schiapparelli Biosystems, Inc. | 1997-11-04 |
| PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) (K970853) | Cardima, Inc. | 1997-11-04 |
| SMARTVAC SMOKE EVACUATION SYSTEM (K970352) | Isomedix Operations, Inc. | 1997-11-04 |
| VENTRAL WALL DEFECT REDUCTION SILO (K973082) | Specialty Surgical Products, Inc. | 1997-11-04 |
| OTICON DIGISOUND COMPACT (K973886) | Oticon, Inc. | 1997-11-04 |
| OTICON DIGISOUND ITE (K973885) | Oticon, Inc. | 1997-11-04 |
| BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC (K964926) | Joerns Healthcare, Inc. | 1997-11-03 |
| INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (K973023) | Hollister, Inc. | 1997-11-03 |
| THEROX INFUSION GUIDEWIRES (K971719) | Therox, Inc. | 1997-11-03 |
| PARTNERSHIP REVISION FEMORAL STEMS (K972893) | Howmedica Corp. | 1997-11-03 |
| THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* (K973281) | United States Surgical, A Division of Tyco Healthc | 1997-11-03 |
| PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES (K971912) | Xintec Corporation | 1997-11-03 |
| EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS (K972994) | Integra Neurocare, LLC | 1997-11-03 |
| DYNA T-2000 PHYSICAL THERAPY SYSTEM (K955808) | Thermia, Inc. | 1997-11-03 |
| KERBOULL CROSS (K972928) | Howmedica, Inc. | 1997-11-03 |
| MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT (K972944) | Medtronics Interventional Vascular | 1997-11-03 |
| DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM (K973060) | Depuy, Inc. | 1997-11-03 |
| ERCO-VAC (K972537) | Ercons, Inc. | 1997-11-03 |
| STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE (K973031) | R. Thomas Grotz, M.D., Inc. | 1997-11-03 |
| C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 (K973378) | Fresenius USA, Inc. | 1997-11-03 |
| STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM (K973627) | Cobe Cardiovascular, Inc. | 1997-11-03 |
| DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM (K971730) | Depuy, Inc. | 1997-11-03 |
| QUICK-CARE BIOPSY NEEDLE (K973565) | Cook, Inc. | 1997-11-03 |
| APR POROUS HA HIP SYSTEM (K973124) | Sulzer Orthopedics, Inc. | 1997-11-03 |
| TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 (K970482) | Srs Intl. | 1997-10-31 |
| APOLLO (K972882) | Norland Corp. | 1997-10-31 |
| ACCUCOLOR HIGH CALIBRATOR (A3089) (K973274) | Sigma Diagnostics, Inc. | 1997-10-31 |
| TRUQUANT BR RIA (K965141) | Biomira USA, Inc. | 1997-10-31 |