| 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES (K971444) | 3M Medical Products Group | 1997-06-11 |
| CLYDE CORONARY GUIDEWIRE (K970528) | Schneider (Europe) GmbH | 1997-06-10 |
| HOTMAN (K952172) | Hemo Sapiens, Inc. | 1997-06-10 |
| PTCA GUIDEWIRE (K970376) | Lake Region Mfg., Inc. | 1997-06-06 |
| INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K970843) | Intervascular, Inc. | 1997-06-05 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W (K971235) | Alexander Mfg. Co. | 1997-06-05 |
| PACE 101H (K970497) | Sulzer Oscor, Inc. | 1997-06-04 |
| SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES (K965062) | Siemens Medical Solutions USA, Inc. | 1997-06-04 |
| FOGARTY VALVULOTOME MODEL 700091 (K965137) | Baxter Edwards | 1997-06-04 |
| SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER (K970823) | Scimed Life Systems, Inc. | 1997-06-03 |
| USCI MAINSTAY GUIDING CATHETER (K971034) | C.R. Bard, Inc. | 1997-05-28 |
| Cordis Endeavor Infusion Catheter (K970842) | Cordis Corp. | 1997-05-28 |
| ULTRAVERSE PTA CATHETER (K964881) | Vas-Cath, Inc. | 1997-05-28 |
| STELA MODEL BJ44 AND BJ45 PACING LEADS (K963738) | Ela Medical, Inc. | 1997-05-23 |
| OCCLUSION CLAMP** DEVICE (K964251) | United States Surgical, A Division of Tyco Healthc | 1997-05-23 |
| 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 |
| RADIUS PTCA GUIDEWIRE (K970466) | Radius Medical Technologies, Inc. | 1997-05-20 |
| LOCKING STYLET 2 (K970690) | Cook Pacemaker Corp. | 1997-05-20 |
| 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER (K964868) | Micro Therapeutics, Inc. | 1997-05-20 |
| ZOLL AUTOCLAVABLE INTERNAL HANDLES (K963781) | Zoll Medical Corp | 1997-05-20 |
| MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (K953647) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-05-16 |
| 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 |
| FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (K964518) | Daig Corp. | 1997-05-14 |
| ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) (K970787) | Alexander Mfg. Co. | 1997-05-14 |
| ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) (K970784) | Alexander Mfg. Co. | 1997-05-14 |
| CHASE LEFT VENT SAFETY VALVE (K964391) | Chase Medical, Inc. | 1997-05-13 |
| CHASE CORONARY OSTIAL PERFUSION CANNULA (K971041) | Chase Medical, Inc. | 1997-05-13 |
| CHASE AORTIC PERFUSION CANNULA (K970914) | Chase Medical, Inc. | 1997-05-13 |
| OPTI-PLAST XL 5.5 F PTA CATHETER (K970725) | Vas-Cath, Inc. | 1997-05-09 |
| HANNIBAL GUIDEWIRE (K970494) | Schneider (Europe) GmbH | 1997-05-09 |
| HEARTPORT THORACIC TROCAR (K964302) | Heartport, Inc. | 1997-05-09 |
| DASH 1000 PATIENT MONITOR (K970545) | Marquette Medical Systems, Inc. | 1997-05-08 |
| EVT ANGIOSCALE ANGIOGRAPHIC CATHETER (K970469) | Guidant Cardiac and Vascular Surgery | 1997-05-08 |
| BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER (K964814) | Bipore, Inc. | 1997-05-07 |
| VISTA BRITE TIP CATHETERS (K963962) | Cordis Corp. | 1997-05-07 |
| HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT (K964188) | Healthcare Service and Supply | 1997-05-06 |
| VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR (K955816) | Baxter Healthcare Corp | 1997-05-06 |
| 3F ANGIOPTIC ANGIOGRAPHIC CATHETER (K964033) | AngioDynamics, Inc. | 1997-05-06 |
| SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER (K970368) | Siemens Medical Solutions USA, Inc. | 1997-05-06 |
| CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR (K970463) | Terumo Medical Corp. | 1997-05-06 |
| CORDIS OPTA5 PTA BALLOON CATHETER (K970620) | Cordis Corp. | 1997-05-06 |
| TRANSJUGULAR ACCESS SET (K964034) | AngioDynamics, Inc. | 1997-05-06 |
| MEDILOG FD4 (K970902) | Oxford Instruments Medical Systems | 1997-05-05 |
| HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES (K964625) | Intervascular, Inc. | 1997-05-05 |
| TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE (K963418) | Transmedica, Inc. | 1997-05-02 |
| FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR (K964187) | Fukuda Denshi USA, Inc. | 1997-05-01 |
| CHANNEL BALLOON CATHETER (K970379) | Boston Scientific Corp | 1997-05-01 |
| BK-A; BK-B; BK-IS SEALING CAP (K970204) | Biotronik, Inc. | 1997-04-29 |
| MEDRAD DISPOSABLE SYRINGES (K964642) | Medrad, Inc. | 1997-04-29 |
| SPACELABS MEDICAL ECG ANALYSIS SYSTEM (K962930) | Spacelabs Medical, Inc. | 1997-04-25 |
| VANTAGE PERIPHERAL DILATATION CATHETER (K965183) | Guidant Corp. | 1997-04-24 |
| JUPITER PTA CATHETERS (VARIOUS) (K970299) | Cordis Corp. | 1997-04-24 |
| CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM (K970392) | Cordis Corp. | 1997-04-24 |
| EVS (K963886) | Applied Medical Resources | 1997-04-24 |
| THERMAL REGULATION SYSTEM BLANKET (K964377) | Gibeck, Inc. | 1997-04-23 |
| CHASE RETROGRADE CARDIOPLEGIA CANNULA (K964393) | Chase Medical, Inc. | 1997-04-23 |
| TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT (K963731) | Enthermics Medical Systems, Inc. | 1997-04-22 |
| GSI CANNULA WITH INTRODUCER (K970201) | General Surgical Innovations | 1997-04-21 |
| 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES (K970719) | Cardiotronics Systems, Inc. | 1997-04-16 |
| CHASE MULTIPLE PERFUSION SET (K964200) | Chase Medical, Inc. | 1997-04-16 |
| CHASE CURVED LEFT HEART VENT CATHETER (K964194) | Chase Medical, Inc. | 1997-04-16 |
| SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM (K970099) | Nitinol Medical Technologies, Inc. | 1997-04-16 |
| CHASE AORTIC ARCH CANNULA (K964193) | Chase Medical, Inc. | 1997-04-16 |
| CONTINUOUS FLUSH DEVICE (K962129) | Merit Medical Systems, Inc. | 1997-04-15 |
| IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K971192) | Impra, Inc. | 1997-04-15 |
| STEALTHSHIELD (K970755) | Vital Connections, Inc. | 1997-04-15 |
| IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM (K961924) | Irvine Biomedical, Inc. | 1997-04-11 |
| CARDIO TEAM II (K962937) | Vision Electronics | 1997-04-10 |
| 3M RED DOT 2560 & 2570 MONITORING ELECTRODES (K970796) | 3M Healthcare | 1997-04-09 |
| VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT (K962700) | Vasamedics, LLC | 1997-04-09 |
| HEARTPORT ENDOAORTIC CLAMP (K964161) | Heartport, Inc. | 1997-04-04 |
| FLEXIBLE DILATING SHEATH (K945586) | Med Institute, Inc. | 1997-04-04 |
| CTS MIDCAB CORONARY SHUNT (K963503) | Cardiothoracic Systems, Inc. | 1997-04-03 |
| SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE (K952912) | Spacelabs Medical, Inc. | 1997-04-02 |
| MICS DEVICE SYSTEM (K963716) | Percutaneous Technologies, Inc. | 1997-04-02 |
| OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR (K964107) | Oscor Medical Corp. | 1997-04-01 |
| CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER (K954547) | Citizen Watch Co., Ltd. | 1997-04-01 |
| D SERIES ELECTRODE (K970603) | Cmc Sense-It, Inc. | 1997-04-01 |
| DUAL LUMEN EMBOLECTOMY CATHETER (K970762) | Applied Medical Resources | 1997-03-28 |
| FOCUS PV BALLOON DILATATION CATHETER (K963688) | Cardiovascular Dynamics, Inc. | 1997-03-28 |
| AIRCAST VENAFLOW SYSTEM (MODIFICATION) (K961676) | Aircast, Inc. | 1997-03-28 |
| COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (K965214) | Coeur Laboratories, Inc. | 1997-03-28 |
| SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES (K970244) | Scimed Life Systems, Inc. | 1997-03-28 |
| MAGNO ALARM (K960849) | Cardiac Assist Devices, Inc. | 1997-03-26 |
| SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION (K962970) | Spacelabs Medical, Inc. | 1997-03-25 |
| SPINNAKER (K965189) | Target Therapeutics | 1997-03-24 |
| CES INFUSION CATHETER (K965181) | Cordis Neurovascular, Inc. | 1997-03-21 |
| FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER (K963057) | Fukuda Denshi USA, Inc. | 1997-03-21 |
| CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (K963698) | International Biophysics Corp. | 1997-03-20 |
| IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K964877) | Impra, Inc. | 1997-03-20 |
| CHASE CORONARY SINUS PERFUSION CANNULA (K964199) | Chase Medical, Inc. | 1997-03-19 |
| CHASE TWO STAGE VENOUS RETURN CATHETER (K964195) | Chase Medical, Inc. | 1997-03-19 |
| VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 (K962141) | B.Braun Medical, Inc. | 1997-03-19 |
| CAHSE AORTIC ROOT CANNULA (K964198) | Chase Medical, Inc. | 1997-03-19 |
| MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (K960766) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 |
| CARDIOBEEPER CB-12L (K965101) | Meridian Medical Technologies, Inc. | 1997-03-17 |
| DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 (K964987) | Datascope Corp. | 1997-03-17 |