| VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER (K964908) | Sorin Biomedical, Inc. | 1997-09-03 |
| 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL (K972113) | Boston Scientific Corp | 1997-09-02 |
| OPUS S MODEL 4121 AND 4124 PACEMAKERS (K970072) | Ela Medical, Inc. | 1997-08-29 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER (K970296) | Boston Scientific Corp | 1997-08-29 |
| MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM (K970347) | Paladin Medical, Inc. | 1997-08-29 |
| INFUSASLEEVE IIA (IS-2A) (K972175) | Localmed, Inc. | 1997-08-28 |
| COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR (K970769) | Aristo Medical | 1997-08-28 |
| MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (K972970) | Graphic Controls Corp. | 1997-08-27 |
| CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE (K972503) | Sorin Group Italia S.R.L. | 1997-08-26 |
| NPB-190 PULSE OXIMETER (NPB-190) (K971946) | Nellcor Puritan Bennett, Inc. | 1997-08-25 |
| ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING (K972142) | Guidant Corp. | 1997-08-25 |
| CHASE BLOOD VESSEL SHUNT (K972665) | Chase Medical, Inc. | 1997-08-22 |
| VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT (K964907) | Sorin Biomedical, Inc. | 1997-08-21 |
| NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH (K972310) | Nihon Kohden America, Inc. | 1997-08-20 |
| DM-400 HOLTER ECG CASSETTE RECORDER (K970298) | Diagnostic Monitoring | 1997-08-20 |
| ORIGIN CARDIAC STABLIZER OCCLUDER (K970611) | Origin Medsystems, Inc. | 1997-08-19 |
| DINAMAP COMPACT MONITOR (K970182) | Johnson & Johnson Medical, Inc. | 1997-08-18 |
| CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM (K965140) | Cardio Metrics, Inc. | 1997-08-18 |
| PRINTER INTERFACE (K970305) | Micromedical, Inc. | 1997-08-15 |
| SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER (K970348) | Siemens Medical Solutions USA, Inc. | 1997-08-15 |
| BK-N SEALING CAP (K971930) | Biotronik, Inc. | 1997-08-14 |
| Cordis Endeavor Infusion Catheter (K972110) | Cordis Corp. | 1997-08-14 |
| A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (K970388) | Biotronik, Inc. | 1997-08-14 |
| THE CIRCULATOR BOOT (K971026) | Circulator Boot Corp. | 1997-08-14 |
| HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET (K963073) | Harmac Medical Products, Inc. | 1997-08-14 |
| HARMAC THERMODILUTION CATHETER (K963336) | Harmac Medical Products, Inc. | 1997-08-14 |
| SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (K964784) | Quinton, Inc. | 1997-08-13 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 (K971828) | Alexander Mfg. Co. | 1997-08-12 |
| CHASE PHRENIC NERVE PAD (K971021) | Chase Medical, Inc. | 1997-08-12 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 (K971827) | Alexander Mfg. Co. | 1997-08-12 |
| ECG REVIEW STATION (K942685) | Mortara Instrument, Inc. | 1997-08-12 |
| ARRHYTHMIA MAPPING SYSTEM (8100/8300) (K965066) | Cardiac Pathways Corp. | 1997-08-11 |
| THROMBOLYTIC BRUSH CATHETER (K963925) | Micro Therapeutics, Inc. | 1997-08-08 |
| FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 (K970027) | Rmds, Inc. | 1997-08-08 |
| VISION CARDIOPLEGIA DELIVERY SYSTEM (K964571) | Lifestream Int'L, Inc. | 1997-08-08 |
| TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) (K970014) | Delphi Consulting Group | 1997-08-06 |
| AFFINITY BLOOD PUMP SYSTEM (K964017) | Avecor Cardiovascular, Inc. | 1997-08-05 |
| 40 CC SUMO (K971673) | Boston Scientific Corp | 1997-08-05 |
| MEDI-DYNE GUIDING CATHETER (K970401) | Medi-Dyne, Inc. | 1997-08-01 |
| EVT EXPANDABLE SHEATH (K970470) | Guidant Cardiac and Vascular Surgery | 1997-07-31 |
| MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS (K970207) | Boston Scientific Corp | 1997-07-31 |
| SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM (K970920) | Siemens Medical Solutions USA, Inc. | 1997-07-29 |
| FIRST MEDIC PULSE OXIMETRY MODULE (K955890) | Colorado Medtech, Inc. | 1997-07-28 |
| A-V IMPULSE SYSTEM MODEL 6060 (K964425) | Powell,Goldstein,Frazer & Murphy | 1997-07-28 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP (K971604) | Alexander Mfg. Co. | 1997-07-28 |
| CARD GUARD, MODEL CG-7100 (K964836) | Card Guard Scientific Survival , Ltd. | 1997-07-28 |
| ANNULOFLO SYSTEM (K970375) | Carbomedics, Inc. | 1997-07-25 |
| PERCUTANEOUS VENOUS INTRODUCER 10264 (K965167) | Medamicus, Inc. | 1997-07-25 |
| ARROW-TREROTOLA PTD CATHETER (K970080) | Arrow Intl., Inc. | 1997-07-25 |
| MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS (K971607) | Boston Scientific Corp | 1997-07-24 |
| POSEIDON CARDIAC MONITORING SYSTEM (PCMS) (K964408) | Instromedix, Inc. | 1997-07-23 |
| CAMOUFLAGE CUFF SAVERS (K963987) | N.A. Braggs Medical, Inc. | 1997-07-23 |
| SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) (K971968) | Remington Medical, Inc. | 1997-07-23 |
| ENVOY GUIDING CATHETER (K965247) | Cordis Neurovascular, Inc. | 1997-07-23 |
| INTRODUCER SHEATH AND DILATOR (K971165) | Boston Scientific Corp | 1997-07-23 |
| COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR (K971669) | Cobe Cardiovascular, Inc. | 1997-07-23 |
| CORDIS POWERFLEX PLUS PTA BALLOON CATHETER (K971516) | Cordis Corp. | 1997-07-23 |
| MODEL 6495 BIPOLAR TEMPORARY PACING LEAD (K963898) | Medtronic Vascular | 1997-07-22 |
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K971608) | Cordis Corp. | 1997-07-21 |
| UNI-GRAFT K DV (K963790) | Atrium Medical Corp. | 1997-07-21 |
| CHASE VESSEL CANNULA (K971019) | Chase Medical, Inc. | 1997-07-21 |
| CORDIS OPTA 5 PTA BALLOON CATHETER (K971579) | Cordis Corp. | 1997-07-18 |
| CARDIOMAGIC 2000 SOFTWARE (K964036) | Instromedix, Inc. | 1997-07-18 |
| COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 (K964821) | Ventrex, Inc. | 1997-07-16 |
| OXIMETER PRE-AMP CABLE (K965172) | Epic Medical Equipment Services, Inc. | 1997-07-16 |
| NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES (K971355) | Nihon Kohden America, Inc. | 1997-07-15 |
| 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER (K971646) | Cordis Corp. | 1997-07-14 |
| MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL (K971474) | Medtronic Vascular | 1997-07-14 |
| MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR (K970763) | Medical Data Electronics | 1997-07-14 |
| COBE CENTURY PERFUSION PUMP (K960974) | Cobe Cardiovascular, Inc. | 1997-07-14 |
| GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE (K971395) | Target Therapeutics | 1997-07-14 |
| FG INFUSION CATHETER (K971306) | Cordis Neurovascular, Inc. | 1997-07-14 |
| VISTA BRITE TIP CATHETERS (K971572) | Cordis Corp. | 1997-07-14 |
| MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM (K971105) | Avecor Cardiovascular, Inc. | 1997-07-11 |
| ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K964190) | Biotronik, Inc. | 1997-07-10 |
| ASC BALANCE MIDDLEWEIGHT GUIDE WIRE (K971815) | Guidant Corp. | 1997-07-09 |
| NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES (K971194) | Nihon Kohden America, Inc. | 1997-07-09 |
| NICAS(TM) ELECTRODE (K972001) | Ni Medical | 1997-07-08 |
| CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE (K961734) | Terumo Medical Corp. | 1997-07-07 |
| CORDIS OPTA LP PTA BALLOON CATHETER (K971448) | Cordis Corp. | 1997-07-03 |
| TRANSEND EX PLATINUM GUIDEWIRE (K971254) | Boston Scientific Corp | 1997-07-01 |
| QA-40M DEFIBRILLATOR TESTER (K963190) | Metron U.S., Inc. | 1997-07-01 |
| SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) (K965236) | Datascope Corp. | 1997-07-01 |
| V2 (K970481) | Survivalink Corp. | 1997-07-01 |
| LMI THROMBECTOMY CATHETER (K970657) | Lucas Medical, Inc. | 1997-07-01 |
| DIASCOPE TRAVELLER PLUS (4053) (K964593) | S & W Medico Teknik A/S | 1997-06-30 |
| PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) (K963578) | Intl. Products, Inc. | 1997-06-30 |
| DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 (K971753) | Denver Biomaterials, Inc. | 1997-06-27 |
| ESCORT LINK CENTRAL STATION MONITOR (K970012) | Medical Data Electronics | 1997-06-26 |
| BAIR HUGGER MODEL 630 CARDIAC BLANKET (K964673) | Augustine Medical, Inc. | 1997-06-26 |
| HARMAC QUADPOLAR MAPPING PACING CATHETER (K963074) | Harmac Medical Products, Inc. | 1997-06-25 |
| SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION (K962811) | Spacelabs Medical, Inc. | 1997-06-24 |
| SVL-9130 DEFIBRILLATION ELECTRODE (K971149) | Survivalink Corp. | 1997-06-23 |
| PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS (K971010) | Cordis Corp. | 1997-06-18 |
| SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT (K964374) | 3M Healthcare | 1997-06-18 |
| FOCUS-PV BALLOON DILATATION CATHETER (K971577) | Cardiovascular Dynamics, Inc. | 1997-06-18 |
| SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT (K964373) | 3M Healthcare | 1997-06-18 |
| 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, (K963920) | Arrow Intl., Inc. | 1997-06-17 |
| HEARTPORT ENDOARTERIAL RETURN CANNULA (K971291) | Heartport, Inc. | 1997-06-17 |
| HBF-1000 OMRON BODY COMPOSITION ANALYZER (K963575) | Omron Healthcare, Inc. | 1997-06-13 |