| MODEL OX-1 OXYGEN SATURATION MODULE (K884822) | Colin Medical Instruments Corp. | 1989-03-02 |
| ASTRO TRACE (MODEL AT-01) (K884592) | The LE Blanc Corp. | 1989-03-02 |
| WELLSHIRE EMLINK MODEL 1000 (K890508) | American Executive Technology | 1989-03-02 |
| KONTRON PULSE OXIMETER 7840 (K890299) | Kontron Instruments, Inc. | 1989-03-02 |
| SARNS VENT CATHETER (K890024) | 3M Company | 1989-03-02 |
| PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. (K890492) | Endosonics Corp. | 1989-03-02 |
| SMDS460 SURGICAL MONITOR DISPLAY SYSTEM (K890353) | Vidco, Inc. | 1989-03-02 |
| CNS-8200A CENTRAL NURSES STATION (K884050) | Nihon Kohden America, Inc. | 1989-02-23 |
| PATIENT MONITOR MODEL 701 (K884096) | Ivy Biomedical Systems, Inc. | 1989-02-23 |
| HEARTSTART 2000 DEFIBRILLATION ELECTRODE (K885186) | Laerdal Mfg. Corp. | 1989-02-23 |
| CARDIOBEEPER IV (K890461) | Survival Technology, Inc. | 1989-02-23 |
| LIFEPAK 10 DEFIBRILLATOR/MONITOR (K890079) | Physio-Control Corp. | 1989-02-23 |
| BP-408 MARK II (K884885) | Colin Medical Instruments Corp. | 1989-02-23 |
| NUPREP (K885306) | Weaver & Co. | 1989-02-23 |
| BP-308 MARK II (K884896) | Colin Medical Instruments Corp. | 1989-02-23 |
| DAIG OBTURATOR, CATHETER INTRODUCER (K884494) | Daig Corp. | 1989-02-22 |
| DAIG COLLAPSIBLE STERILE SLEEVE (K884478) | Daig Corp. | 1989-02-22 |
| SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT (K884159) | Mallinckroot, Inc. | 1989-02-22 |
| INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (K885154) | Medtronic Blood Systems, Inc. | 1989-02-22 |
| ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS (K884811) | Telectronics and Control Pacing Systems | 1989-02-22 |
| FORCEPS-ORTHOPEDIC (K890165) | Dhason Brothers, Inc. | 1989-02-13 |
| MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD (K885240) | Tpl-Cordis, Inc. | 1989-02-10 |
| AFP MODEL 262T PULSE GENERATOR (K884733) | Pacesetter Systems | 1989-02-10 |
| SURGI-CUF STERILE/NON-STERILE DISPOSABLE (K883977) | Ethox Corp. | 1989-02-10 |
| THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) (K883412) | Promedica Products, Inc. | 1989-02-08 |
| JEHLE CORONARY PERFUSION CATHETERS (K884946) | Pilling Co. | 1989-02-06 |
| MODEL 8700 PULSE OXIMETER (K890033) | Nonin Medical, Inc. | 1989-02-06 |
| MODEL 499 SSR ANALYSIS SYSTEM (K884887) | Del Mar Avionics | 1989-02-06 |
| ARBO PINK H82P (K884775) | Arbo Medical, Inc. | 1989-02-06 |
| A10 ULTRASCOPE RECORDER (K890142) | Ems Medical, Inc. | 1989-02-06 |
| AL-800PA PULSE OXIMETER MODULE (K884536) | Nihon Kohden America, Inc. | 1989-02-06 |
| ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE (K884895) | Advanced Cardiovascular Systems, Inc. | 1989-02-06 |
| MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY (K885188) | Quinton, Inc. | 1989-02-06 |
| RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER (K883845) | Phoenix Imaging | 1989-02-03 |
| ESCORT NON-INVASIVE BLOOD PRESSURE OPTION (K884742) | Medical Data Electronics | 1989-02-02 |
| VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (K890350) | Telectronics, Inc. | 1989-02-02 |
| PATIENT MONITOR MODEL 703 (K884662) | Ivy Biomedical Systems, Inc. | 1989-02-02 |
| PATIENT MONITOR RIGEL MODEL MULTICARE 429 (K884645) | Rigel Medical Electronics, Inc. | 1989-02-02 |
| PACH-PEN CALCULATOR (K884619) | Oculab, Inc. | 1989-02-02 |
| MVL/MODULAB WITH PVR MODULE (K884624) | Life Sciences Manufacturing, Inc. | 1989-02-01 |
| EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. (K884614) | Edentec Corp. | 1989-02-01 |
| DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR (K884872) | Shiley, Inc. | 1989-01-30 |
| MODEL 6208,6209,6210,6211,6212,6214 (PLI'S) (K890045) | Medtronic Vascular | 1989-01-30 |
| CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (K884893) | American Omni Medical, Inc. | 1989-01-30 |
| ANGIOSCOPE FOR PULMONARY ARTERY USE (K882658) | Washington Regulatory Services | 1989-01-26 |
| OPTIMA MPT AND SPT PACEMAKERS (K884411) | Telectronics, Inc. | 1989-01-26 |
| MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F (K885296) | Baxter Healthcare Corp | 1989-01-25 |
| UNILITH 3 MODELS 7580/7583/7680/7683 (K883037) | Ela Medical, Inc. | 1989-01-25 |
| MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH (K883454) | Cambridge Medical Instruments, Inc. | 1989-01-25 |
| SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (K885235) | Spectramed, Inc. | 1989-01-25 |
| POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES (K885262) | Valleylab, Inc. | 1989-01-25 |
| SARNS 9000 WITH CENTRIFUGAL PUMP OPTION (K884659) | 3M Health Care, Sarns | 1989-01-24 |
| BARD TAB ECG MONITORING ELECTRODE (K890103) | C.R. Bard, Inc. | 1989-01-24 |
| CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (K884640) | American Omni Medical, Inc. | 1989-01-24 |
| SOFTRAC-PTA PERIPHERAL DILATATION CATHETER (K882826) | Schneider-Shilley (Usa) | 1989-01-24 |
| MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM (K882609) | Waltham Div. Hewlett Packard | 1989-01-19 |
| USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER (K884502) | C.R. Bard, Inc. | 1989-01-18 |
| E550 ELECTROCARDIOGRAPH (K883440) | Burdick Corp. | 1989-01-17 |
| MINIMON 7134B PATIENT MONITOR (K883069) | Kontron Instruments, Inc. | 1989-01-17 |
| MINIMON 7136B PATIENT MONITOR (K883109) | Kontron, Inc. | 1989-01-17 |
| EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER) (K883402) | Quinton, Inc. | 1989-01-17 |
| HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 (K884539) | Rmv Medical (Romavat, Inc.) | 1989-01-17 |
| TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR (K882824) | A&D Engineering, Inc. | 1989-01-17 |
| TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN (K882825) | A&D Engineering, Inc. | 1989-01-17 |
| INTRODUCER SAFETY SYRINGE (K884490) | Arrow Intl., Inc. | 1989-01-17 |
| MEDTRONIC MODEL 4058 PACING LEAD (K883743) | Medtronic Vascular | 1989-01-17 |
| VENTRALITH I (K883750) | Bio Pace Technology, Inc. | 1989-01-13 |
| MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 (K885252) | Ep Technologies, Inc. | 1989-01-13 |
| CORTRONIC SCR1000 (K884911) | Cortronic Corp. | 1989-01-13 |
| PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT (K884421) | Pymah Corp. | 1989-01-13 |
| DOPCORD PPG (K884451) | Huntleigh Technology, Inc. | 1989-01-12 |
| USCI ADJUSTABLE TIP GUIDE WIRE (K884647) | C.R. Bard, Inc. | 1989-01-12 |
| TORAY VASCULAR PROSTHESIS (K884083) | Toray Industries (America), Inc. | 1989-01-12 |
| SENSOCOR(TM) DIASYS (K881771) | Sensormedix, Inc. | 1989-01-12 |
| MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE (K885171) | Andover Medical, Inc. | 1989-01-12 |
| CATH LAB MONITORING CATHETER (K884065) | C.R. Bard, Inc. | 1989-01-12 |
| MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR (K885101) | Medtronic Vascular | 1989-01-12 |
| NAMIC DUAL BACKCHECK VALVE (K884408) | North American Instrument Corp. | 1989-01-12 |
| FUKUDA DENSHI MODEL FX-1201 (K884992) | Fukuda Denshi USA, Inc. | 1989-01-12 |
| TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (K884375) | Argon Medical Corp. | 1989-01-11 |
| MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (K884331) | Medtronic Vascular | 1989-01-10 |
| CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE (K884481) | Mallinckroot, Inc. | 1989-01-10 |
| ANGIOPUMP TUBING SET (K884310) | Olympus Corp. | 1989-01-10 |
| EDENTEC MODEL 4700 SCANNER (K884388) | Edentec Corp. | 1989-01-10 |
| DISPOSABLE DOME STOCK #D-300 (K884919) | Advanced Medical, Inc. | 1989-01-05 |
| ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (K884386) | Ethitek Pharmaceuticals Co. | 1989-01-05 |
| MICRO-GUIDE SYSTEM (K884337) | Catheter Research C/O Burditt, Bowles & Radzius | 1989-01-05 |
| MODEL 463 ELECTROCARDIORECORDER RECORDER (K884330) | Del Mar Avionics | 1989-01-05 |
| ASK-300 (K882977) | Medical Repackers Co. | 1989-01-05 |
| EDENTRACE MULTI-CHARTER MODEL 3700 (K883315) | Edentec Corp. | 1988-12-28 |
| CARDIOCAP(TM) CM-104 MONITOR (K884955) | Datex Division Instrumentarium Corp. | 1988-12-28 |
| PROCEDURE PACKS CONTRAST MEDIA SETS (K882717) | Procedure Packs, Inc. | 1988-12-28 |
| OC-100 OXIMETER INTERFACE CALIBRATOR (K884891) | Telediagnostic Systems, Inc. | 1988-12-28 |
| LIFEPAK 50 MONITOR/DEFIBRILLATOR (K883617) | Physio-Control Corp. | 1988-12-28 |
| SURGICAL CLAMP INSERTS (K883790) | Applied Vascular Devices, Inc. | 1988-12-27 |
| PROPAQ 106(TM) (K884320) | Protocol Systems, Inc. | 1988-12-27 |
| CARDIOCAP(TM) CTO-104 MONITOR (K884956) | Datex Division Instrumentarium Corp. | 1988-12-27 |
| SURGICAL SPRING CLIPS (K883909) | Applied Vascular Devices, Inc. | 1988-12-27 |
| ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301 (K880505) | Ppg Industries, Inc. | 1988-12-27 |
| MODIFIED SHILEY FEMORAL ARTERIAL CANNULA (K884393) | Shiley, Inc. | 1988-12-27 |