| SARNS INGANT MEMBRANE OXYGENATOR (K895393) | 3M Company | 1989-12-04 |
| STETH-SHIELD(TM) (K892890) | North East Technology | 1989-12-01 |
| ANGEION HEMOSTASIS VALVE INTRODUCER (K894446) | Angeion Corp. | 1989-11-30 |
| SCD KNEE IMMOBILIZER (K895278) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1989-11-30 |
| KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN (K895352) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1989-11-29 |
| QUINTON MAHURKAR CATHETERS W/VITACUFF (K895440) | Quinton, Inc. | 1989-11-29 |
| A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20 (K895428) | A&D Engineering, Inc. | 1989-11-28 |
| A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650 (K895429) | A&D Engineering, Inc. | 1989-11-28 |
| SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F (K894168) | Baxter Healthcare Corp | 1989-11-27 |
| DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H (K893678) | Medtronic Blood Systems, Inc. | 1989-11-27 |
| V*S*R(TM) SCOPE (K895545) | Vsr Enterprises Corp. | 1989-11-15 |
| SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) (K895454) | Advance Medical Designs, Inc. | 1989-11-14 |
| HEMOSTASIS VALVE (K895214) | Applied Vascular Devices, Inc. | 1989-11-14 |
| BREVET DISPOSABLE CONNECTORS (K895753) | Brevet, Inc. | 1989-11-14 |
| SELDINGER PERCUTANEOUS 2 PC NEEDLES (K895455) | Advance Medical Designs, Inc. | 1989-11-14 |
| NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI (K893041) | Telectronics Pacing Systems, Inc. | 1989-11-14 |
| NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856) | Acacia Laboratories, Inc. | 1989-11-08 |
| ARROW HANDS-OFF THERMO-PACE (K895268) | Arrow Intl., Inc. | 1989-11-06 |
| CCO SYSTEM MODEL SP1467,SP5567,SP6267 (K892941) | Spectramed, Inc. | 1989-11-06 |
| CMS VRB-1200 (K895076) | Cobe Laboratories, Inc. | 1989-11-03 |
| BABY MAC ELECTROCARDIOGRAPH ELECTRODE (K895834) | Marquette Electronics, Inc. | 1989-11-03 |
| BIO-CAL 370 HEATER/COOLER (K894980) | Bio Medicus, Inc. | 1989-11-02 |
| NANOS (K894239) | Biotronik Cardiac Pacemakers | 1989-11-01 |
| BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES (K892641) | Bard Cardiosurgery Div | 1989-11-01 |
| WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR (K894970) | Minntech Corp. | 1989-11-01 |
| DATASCOPE STEERING HANDLE (K894940) | Datascope Corp. | 1989-11-01 |
| 1100 VITAL SIGNS MONITOR (K884643) | Criticare Systems, Inc. | 1989-10-30 |
| BIOPSY FORCEPS (K895098) | Annex Medical, Inc. | 1989-10-30 |
| SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES (K892323) | Seismed Instruments, Inc. | 1989-10-30 |
| E-RAM (K884126) | Reynolds Medical , Ltd. | 1989-10-30 |
| HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM (K894892) | Koven and Assoc., Inc. | 1989-10-27 |
| FIRST MEDIC MODEL 610P (K895185) | First Medical Devices Corp. | 1989-10-27 |
| COORDINATOR (K895113) | Cardiotronics, Inc. | 1989-10-26 |
| NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER (K893643) | Novametrix Medical Systems, Inc. | 1989-10-26 |
| NON-INVASIVE BLOOD PRESSURE MODULE (K894945) | Marquette Electronics, Inc. | 1989-10-26 |
| PAQ10 PAPER CHART RECORDER (K894607) | Protocol Systems, Inc. | 1989-10-26 |
| NEOS 02 (K894240) | Biotronik Cardiac Pacemakers | 1989-10-26 |
| ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. (K894991) | Labeltape Meditect, Inc. | 1989-10-26 |
| DEFIB/PACING PADS (K894588) | Conmedcorp | 1989-10-26 |
| SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR (K894630) | Shiley, Inc. | 1989-10-20 |
| TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE (K894721) | The Traumafuse Co. | 1989-10-20 |
| MODEL SSH-140A ULTRASOUND IMAGING SYSTEM (K894632) | Toshiba America Medical Systems, In.C | 1989-10-19 |
| DISPOSABLE CATHETER PRESSURE TRANSDUCER (K894033) | Deseret Medical, Inc. | 1989-10-17 |
| CORDIS STEERABLE COATED GUIDEWIRE (K894633) | Cordis Corp. | 1989-10-17 |
| PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT (K894684) | Pioneering Technologies, Inc. | 1989-10-17 |
| LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD (K894494) | Biotronik, GmbH & Co. | 1989-10-17 |
| CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512 (K890875) | Ppg Industries, Inc. | 1989-10-17 |
| PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER (K894286) | Ppg Industries, Inc. | 1989-10-12 |
| P POLYMER (K893990) | Pace West | 1989-10-12 |
| HEMO-ALERT (K893830) | Koregon Enterprise, Inc. | 1989-10-12 |
| OLYMPUS VALVULOTOME W/FIXED TIP (K894496) | Olympus Corp. | 1989-10-12 |
| PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) (K891786) | Pioneering Technologies, Inc. | 1989-10-12 |
| DATASCOPE INTERLOCK GUIDE WIRE EXTENSION (K894318) | Datascope Corp. | 1989-10-12 |
| ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP. (K894976) | Medtronic Vascular | 1989-10-12 |
| TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000 (K894540) | Physio-Control Corp. | 1989-10-12 |
| CARE DISP. DIAG. ELECTRODES, SILVER/SILVER (K894462) | Labeltape Meditect, Inc. | 1989-10-12 |
| REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER (K894681) | Shiley, Inc. | 1989-10-12 |
| FEM-FLEX FEMORAL ACCESS CANNULATION SET (K891576) | Research Medical, Inc. | 1989-10-12 |
| ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES (K895032) | Zmi Corp. | 1989-10-12 |
| CARE 5000 SYSTEM (K894858) | Care Systems, Inc. | 1989-10-12 |
| VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION) (K894732) | Medtronic Vascular | 1989-10-12 |
| R2 PACE PAD, MODEL 480 (K895729) | Darox Corp. | 1989-10-12 |
| PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. (K894747) | Endosonics Corp. | 1989-10-12 |
| R2 PACE ADAPTOR CABLE, MODEL 196 (K895728) | Darox Corp. | 1989-10-12 |
| SELECTRODE (K894920) | S & W Medico Teknik | 1989-10-03 |
| ERGOMED 840/ERGOMED 840L (K885085) | Burdick Corp. | 1989-10-03 |
| CARDIOBEEPER MEMORY MONITOR CB 600 SERIES (K894799) | Survival Technology, Inc. | 1989-10-03 |
| PCI MODEL 2041-A TELEMETRY MONITOR (K894340) | Accucore, Inc. | 1989-10-02 |
| TYPE 9140 (SYSTEM ATHENA) (K894699) | S & W Medico Teknik | 1989-10-02 |
| MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE (K894445) | Mallinckroot, Inc. | 1989-10-02 |
| HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM (K893094) | Heartware Intl. Corp. | 1989-10-02 |
| MODEL DS-504 DYNASCOPE PATIENT MONITOR (K893405) | Fukuda Denshi USA, Inc. | 1989-10-02 |
| AP-851PA NIBP MODULE (K894693) | Nihon Kohden America, Inc. | 1989-10-02 |
| TYPE PDU/CDU 9040 (SYSTEM ATHENA) (K894700) | S & W Medico Teknik | 1989-10-02 |
| BEDSIDE MONITORS, BSM-8301A, BSM-8302A (K894692) | Nihon Kohden America, Inc. | 1989-10-02 |
| SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA (K894460) | Siemens Medical Electronics | 1989-10-02 |
| OBTURATOR (K894157) | Argon Medical Corp. | 1989-09-28 |
| TARGET THERAPEUTICS TRACKER LF CATHETER (K894105) | Target Therapeutics | 1989-09-28 |
| MINIMON 7137B PATIENT MONITOR (K895425) | Kontron Instruments, Inc. | 1989-09-26 |
| EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS (K890597) | D-R Medical Systems, Inc. | 1989-09-26 |
| DMI PC HOLTER SCANNER (K894285) | Diagnostic Medical Instruments | 1989-09-26 |
| MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING (K893471) | Medtronic Vascular | 1989-09-26 |
| DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO (K894343) | Daig Corp. | 1989-09-26 |
| OPUS MODEL 4001 (K894065) | Ela Medical, Inc. | 1989-09-26 |
| CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH (K892530) | Arrow Intl., Inc. | 1989-09-26 |
| ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP (K894255) | St. Jude Medical, Inc. | 1989-09-26 |
| DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 (K894131) | Thermedics, Inc. | 1989-09-26 |
| SILICONE FLOW-DIRECTED THERMODILUTION CATHETER (K893435) | Cathlab Corp. | 1989-09-26 |
| ESCORT PULSE OXIMETRY OPTION (K892120) | Medical Data Electronics | 1989-09-26 |
| ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS (K895495) | Medtronic Vascular | 1989-09-26 |
| M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME (K894277) | Hewlett-Packard Co. | 1989-09-26 |
| SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER (K894942) | Boston Scientific Corp | 1989-09-26 |
| MAESTRO PACEMAKER TEST MAGNET (K895110) | Cardiac Control Systems, Inc. | 1989-09-26 |
| FLEXMEDICS GUIDEWIRE (K893626) | Flexmedics | 1989-09-26 |
| HOLTAIN BODY COMPOSITION ANALYSER (K891928) | Seritex, Inc. | 1989-09-22 |
| SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II (K894103) | Scimed Life Systems, Inc. | 1989-09-21 |
| MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE (K894981) | Medtronic Vascular | 1989-09-20 |
| 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON (K892798) | Kontron Instruments, Inc. | 1989-09-20 |
| 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON (K892799) | Kontron Instruments, Inc. | 1989-09-20 |
| PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE) (K893459) | Medtronic Vascular | 1989-09-20 |