| POCKET MANOMETER (K880599) | Abbott Laboratories | 1988-10-06 |
| USCI SOFT-TIP ANGIOGRAPHIC CATHETER (K883051) | C.R. Bard, Inc. | 1988-10-06 |
| SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR (K882380) | Scimed Life Systems, Inc. | 1988-10-06 |
| TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE (K883523) | Cardiotronics, Inc. | 1988-10-06 |
| TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 (K882904) | Tdk Corp. | 1988-10-05 |
| POLY-TAC (K882235) | Cardiovascular Group, Inc. | 1988-10-05 |
| ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER (K881966) | C.R. Bard, Inc. | 1988-10-04 |
| VASCUCARE ANGIOPUMP (K881780) | Vascucare, Inc. | 1988-09-28 |
| SARNS INFANT VENOUS RESERVOIR MODEL #16387 (K883345) | 3M Health Care, Sarns | 1988-09-28 |
| ACS SCHWARTEN XT BALLOON DILATATION CATHETER (K882925) | Advanced Cardiovascular Systems, Inc. | 1988-09-28 |
| MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH (K881825) | Spectramed, Inc. | 1988-09-28 |
| MEMBRANE OXYGENATOR (K882892) | Baxter Bentley Laboratories, Inc. | 1988-09-27 |
| MODEL PM-20A PHYSIOLOGICAL MONITOR (K880756) | Advanced Medical Systems, Inc. | 1988-09-27 |
| PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP (K882981) | Pioneering Technologies, Inc. | 1988-09-27 |
| TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE (K882928) | Advanced Cardiovascular Systems, Inc. | 1988-09-27 |
| EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER (K882771) | Cook, Inc. | 1988-09-27 |
| FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT (K881632) | Huntleigh Technology, Inc. | 1988-09-26 |
| SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F (K883346) | Devices For Vascular Intervention, Inc. | 1988-09-26 |
| PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) (K883135) | Pioneering Technologies, Inc. | 1988-09-26 |
| SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II (K883054) | Scimed Life Systems, Inc. | 1988-09-26 |
| VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER (K881851) | Micro Medical, Ltd. | 1988-09-26 |
| BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 (K883330) | Shiley, Inc. | 1988-09-26 |
| VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT (K882969) | Gish Biomedical, Inc. | 1988-09-26 |
| BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 (K883331) | Shiley, Inc. | 1988-09-26 |
| MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 (K883332) | Shiley, Inc. | 1988-09-26 |
| SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A (K883053) | Scimed Life Systems, Inc. | 1988-09-26 |
| CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 (K882427) | Ela Medical, Inc. | 1988-09-23 |
| EPICARDIA PC/FC (K883103) | Medicomp, Inc. | 1988-09-22 |
| QUIK-PACE II ELECTRODES (K883121) | Physio-Control Corp. | 1988-09-20 |
| HOLTER SCANNER (K881488) | Cardiodata Corp. | 1988-09-20 |
| Q-CATH RM (K883031) | Quinton, Inc. | 1988-09-20 |
| JOBST EXTREMITY PUMP(R) SYSTEM 7500 (K882683) | Jobst Institute, Inc. | 1988-09-20 |
| MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A (K875179) | Tsi, Inc. | 1988-09-19 |
| PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE (K882655) | Procedure Packs, Inc. | 1988-09-16 |
| MRL OXIMETER (K882664) | Medical Research Laboratories, Inc. | 1988-09-16 |
| POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP (K883016) | Cardiac Control Systems, Inc. | 1988-09-16 |
| ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST (K882803) | Advanced Cardiovascular Systems, Inc. | 1988-09-16 |
| INTERSEPT*PREBYPASS FILTER (K883086) | Medtronic Blood Systems, Inc. | 1988-09-16 |
| BARO-GRAF 24 (K881297) | Instromedix, Inc. | 1988-09-16 |
| SCIMED R30 SILICONE ASSIST RESERVOIR (K882720) | Scimed Life Systems, Inc. | 1988-09-16 |
| PROCEDURE PACKS SOLUTION ADMINISTRATION SETS (K882716) | Procedure Packs, Inc. | 1988-09-16 |
| OMEGA NV(TM) BALLOON DILATATION CATHETER (K882052) | Cook, Inc. | 1988-09-14 |
| PROLOG MP 658M PULSE GENERATOR (K883087) | Pacesetter Systems | 1988-09-14 |
| MX860, REUSABLE PRESSURE TRANSDUCER (K883095) | Medex, Inc. | 1988-09-12 |
| OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 (K882476) | Ela Medical, Inc. | 1988-09-12 |
| TRU-TRAC TORQUE GUIDEWIRE (K880288) | N-S Medical Products | 1988-09-12 |
| HEARTSTART 1000 (K883341) | Laerdal Mfg. Corp. | 1988-09-12 |
| PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) (K882879) | Pioneering Technologies, Inc. | 1988-09-12 |
| HEARTSTART 1000S (K883344) | Laerdal Mfg. Corp. | 1988-09-12 |
| TRU-TRAC COILED GUIDEWIRE (K880287) | N-S Medical Products | 1988-09-12 |
| OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 (K882474) | Ela Medical, Inc. | 1988-09-12 |
| MYOCARD BIOPSY FORCEP (K881412) | Fehling Medizintechnik GmbH | 1988-09-08 |
| MODEL 5866-34A PACEMAKER LEAD ADAPTOR (K883203) | Medtronic Vascular | 1988-09-06 |
| BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER (K882330) | C.R. Bard, Inc. | 1988-09-06 |
| RK2000 K-THERMIA SYSTEM (K882442) | Baxter Healthcare Corp | 1988-09-06 |
| BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD (K883602) | Intermedics, Inc. | 1988-09-06 |
| NUMED BALLOON THERMODILUTION CATHETER (K881893) | NuMED, Inc. | 1988-09-06 |
| L-F COILED EXTENSION TUBING (K882329) | Mallinckrodt Group, Inc. | 1988-09-02 |
| DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP (K882393) | Omron Electronics, Inc. | 1988-08-30 |
| DIGITAL MEDICINE ECG MONITOR AND RECORDER (K880971) | Digital Medicine Systems | 1988-08-30 |
| ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT (K882321) | Advanced Cardiovascular Systems, Inc. | 1988-08-30 |
| MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE (K882338) | Cardiotronics, Inc. | 1988-08-30 |
| MODEL #918 MULTI-PADS (K883375) | Cardiotronics, Inc. | 1988-08-30 |
| MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM (K882593) | Cardio Metrics, Inc. | 1988-08-29 |
| HORIZON 2000 PULSE OXIMETRY AND MODULE (K882273) | Mennen Medical, Inc. | 1988-08-25 |
| MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD (K882452) | Medtronic Vascular | 1988-08-25 |
| VESSEL DILATOR AND INTRODUCER SHEATH (K882238) | Ideal Medical, Inc. | 1988-08-25 |
| METATECH MICROCLIP APPLICATOR (K882367) | Metatech Corp. | 1988-08-25 |
| ECG MONITOR AND RESPIRATION PACER (K881055) | D. E. Hokanson, Inc. | 1988-08-19 |
| TAPER FLEX-TIP STEERABLE GUIDEWIRE (K880762) | Target Therapeutics | 1988-08-19 |
| 3000 PHYSIOLOGICAL MONITOR (K880301) | Datascope Corp. | 1988-08-19 |
| COATING FOR WIRE GUIDE (K880722) | Cook, Inc. | 1988-08-19 |
| TAPER-22 STEERABLE GUIDEWIRE (K880761) | Target Therapeutics | 1988-08-19 |
| EXTERNAL PACEMAKER 2000 (EP2000) (K882168) | Unomed, Inc. | 1988-08-19 |
| OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE (K882221) | Argon Medical Corp. | 1988-08-12 |
| SENTORR ARTERIAL PRESSURE SENSOR (K880830) | Ohmeda Medical | 1988-08-12 |
| EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 (K882137) | Medtronic Blood Systems, Inc. | 1988-08-12 |
| MINIMON 7131B PATIENT MONITOR (K882197) | Kontron Instruments, Inc. | 1988-08-12 |
| GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER (K881723) | Biosound, Inc. | 1988-08-12 |
| INTERSEPT* OXYGEN GAS LINE FILTER (K882136) | Medtronic Blood Systems, Inc. | 1988-08-11 |
| NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS (K875127) | Novoste Corp. | 1988-08-09 |
| TELSTETH TELEMETRIC STETHOSCOPE(TM) (K882119) | Quantsonics, Inc. | 1988-08-08 |
| CORONARY VEIN GRAFT MARKER (K882314) | Med-Edge, Inc. | 1988-08-04 |
| ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW (K881897) | Advanced Cardiovascular Systems, Inc. | 1988-08-03 |
| RHYTHMSCAN HR HOLTER RECORDER (K882366) | Brentwood Instruments, Inc. | 1988-08-02 |
| MODEL MICRO SI AMBULATORY ECG MONITOR (K881905) | Advanced Medical Products, Inc. | 1988-08-02 |
| SYSTEM5RH STATIONARY EXERCISE BICYCLE (K881475) | Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. | 1988-08-02 |
| MODEL 700 PATIENT MONITOR (K882118) | Ivy Biomedical Systems, Inc. | 1988-08-02 |
| OMNIGRAPH 6000 (K880357) | Telemed Div. | 1988-08-02 |
| CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES (K880575) | Nihon Kohden America, Inc. | 1988-08-02 |
| MODEL #825 ADULT STIM. PADS POLYMER TYPE (K882337) | Cardiotronics, Inc. | 1988-08-02 |
| SLIP-COAT(TM) CATHETERS (K882796) | Cook, Inc. | 1988-07-28 |
| HARBOR CENTRAL VENOUS CATHETER (K881884) | Harbor Medical Devices, Inc. | 1988-07-28 |
| MEDRAD OPEN ENDED GUIDEWIRE (K880332) | Medrad, Inc. | 1988-07-28 |
| CORDIS PTA DILATATION CATHETERS (K880612) | Cordis Corp. | 1988-07-28 |
| CARDIOCAP(TM) CMO-104 MONITOR (K882093) | Datex Division Instrumentarium Corp. | 1988-07-28 |
| MODIFIED PERIPHERAL DILATATION CATHETERS (K875175) | Schneider-Shilley (Usa) | 1988-07-28 |
| INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER (K882034) | Buckman Co., Inc. | 1988-07-28 |
| MINIMON 7132B PATIENT MONITOR (K882198) | Kontron Instruments, Inc. | 1988-07-28 |
| HEART-CHILL SALINE SLUSH PAD (K882035) | Buckman Co., Inc. | 1988-07-28 |