| MODEL #911 STEALTH MULTI PADS (K912621) | Cardiotronics, Inc. | 1991-10-16 |
| MODEL #110 STEALTH-TRODE CHILD DEFIB PADS (K911456) | Cardiotronics, Inc. | 1991-10-16 |
| SUB-4(TM), PERIPHERAL DILATATION CATHETER (K913689) | Boston Scientific Corp | 1991-10-16 |
| WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM (K913600) | Ralin Laboratories, Inc. | 1991-10-16 |
| IVT GUIDING CATHETER (K911869) | Intensive Technology, Inc. | 1991-10-16 |
| MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (K905403) | Cook Pacemaker Corp. | 1991-10-16 |
| CARD GUARD, MODELS CG-6000 & CG-7000 (K910884) | Card Guard Scientific Survival , Ltd. | 1991-10-16 |
| MODEL #100 SHOCK-TRODE CHILD DEFIB PADS (K911455) | Cardiotronics, Inc. | 1991-10-16 |
| MODEL 100 CENTRAL STATION (K913193) | Protocol Systems, Inc. | 1991-10-16 |
| CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL (K913801) | Cordis Corp. | 1991-10-16 |
| SATURATION/HEMATOCRIT MONITOR SYSTEM (K910421) | Medtronic Vascular | 1991-10-15 |
| DATASCOPE PASSPORT MONITOR (K911598) | Datascope Corp. | 1991-10-15 |
| GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM (K912107) | W. L. Gore & Associates, Inc. | 1991-10-11 |
| MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS (K911662) | Marquette Electronics, Inc. | 1991-10-10 |
| SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH (K913297) | Schneider Intl., Ltd. | 1991-10-10 |
| VER-MED A10020 RESTING EKG ELECTRODE (K911687) | Vermont Medical, Inc. | 1991-10-10 |
| PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED (K913110) | Microwave Medical Systems, Inc. | 1991-10-10 |
| VITALMAX 830 SERIES (K913263) | Pace Tech, Inc. | 1991-10-10 |
| BIO-SENSOR 01 EKG ELECTRODE (K911472) | Bio-Sensor, Inc. | 1991-10-10 |
| PEI PLAQUE ELECTRODE ARRAY (K904747) | Prucka Engineering, Inc. | 1991-10-09 |
| NOVOSTE VESSEL DILATER (K912050) | Novaste Corp. | 1991-10-09 |
| TRU-VIEW MULTI-CHANNEL DISPLAY (K912008) | General Devices | 1991-10-09 |
| ACS VSW GUIDE WIRE (K913178) | Advanced Cardiovascular Systems, Inc. | 1991-10-08 |
| THORACIC CATHETER STYLET (K913543) | Intl. Medical Devices , Ltd. | 1991-10-04 |
| SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (K913038) | Spacelabs, Inc. | 1991-10-04 |
| MODEL #350 SHOCK-PLATE DEFIB ADAPTOR (K911402) | Cardiotronics, Inc. | 1991-10-03 |
| IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 (K911194) | Rjl Systems, Inc. | 1991-09-30 |
| SAFEWEDGE(TM) RELIEF VALVE DEVICE (K912172) | Sunscope Intl., Inc. | 1991-09-27 |
| SARNS NON-FILTERED VENOUS RESERVOIR (K912915) | 3M Health Care, Ltd. | 1991-09-25 |
| SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER (K912920) | 3M Health Care, Ltd. | 1991-09-25 |
| CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY (K912833) | Camino Laboratories, Inc. | 1991-09-23 |
| PROFUSE INFUSION SYSTEM (K912877) | Lake Region Mfg., Inc. | 1991-09-23 |
| AMPLANTZ AND BENTSON GUIDEWIRES (K912798) | Meadox Medicals, Div. Boston Scientific Corp. | 1991-09-23 |
| MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM) (K911604) | Medphone Corp. | 1991-09-23 |
| PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION (K913201) | Oscor Medical Corp. | 1991-09-23 |
| IMPLANT PACING LEAD TINED #3390, MODIFICATION (K913203) | Oscor Medical Corp. | 1991-09-23 |
| RIGHT ATRIAL CATHETERS (K911333) | Akcess Medical Products, Inc. | 1991-09-23 |
| CARDIOSWISS CM-8 (K910109) | Care Systems, Inc. | 1991-09-23 |
| OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF (K913205) | Oscor Medical Corp. | 1991-09-23 |
| MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION (K913204) | Oscor Medical Corp. | 1991-09-23 |
| IMPLANT PACING LEAD, TINED #3262, MODIFICATION (K913202) | Oscor Medical Corp. | 1991-09-23 |
| IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION (K913393) | Oscor Medical Corp. | 1991-09-23 |
| MODIFIED OSCOR PY PACING LEADS/MODIFICATION (K913158) | Oscor Medical Corp. | 1991-09-23 |
| TRAC-WRIGHT SYSTEM, MODEL TW2 (K910594) | Dow Corning Wright | 1991-09-23 |
| LOW POROSITY (LP) VASCULAR PROSTHESIS (K912911) | Intervascular, Inc. | 1991-09-23 |
| GALIX MA-6C HOLTER CASSETTE RECORDER (K904177) | Galix Instrumentacion Biomedica | 1991-09-20 |
| GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER (K904176) | Galix Instrumentacion Biomedica | 1991-09-20 |
| CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER (K912777) | Cordis Corp. | 1991-09-20 |
| FURUI SHUNT, 2-WAY AND 3-WAY (K910004) | Theramed, Inc. | 1991-09-19 |
| LEMAITRE-BOOKWALTER VESSEL DEVICES (K912548) | Vascutech, Inc. | 1991-09-18 |
| MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD (K912235) | Intermedics, Inc. | 1991-09-18 |
| PRO-GUIDE (K911747) | American Interventional Technology | 1991-09-18 |
| ECHOMARK CSI INTERFACE (K910965) | Catheter Sciences Co. | 1991-09-17 |
| CORDIS INFLATOR DEVICE (K912644) | Cordis Corp. | 1991-09-16 |
| MEDRAD VARIBLE INFUSION INJECTOR (K905819) | Medrad, Inc. | 1991-09-16 |
| MINIMAX OXYGENATION SYSTEM (K912655) | Medtronic Vascular | 1991-09-13 |
| CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE (K911308) | Medical Equipment Designs, Inc. | 1991-09-11 |
| MX 339 TWIN HEMOSTATIC Y CONNECTOR (K912709) | Medex, Inc. | 1991-09-11 |
| QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC (K912599) | Physio-Control Corp. | 1991-09-11 |
| OPEN ENDED GUIDEWIRE (K912878) | Lake Region Mfg., Inc. | 1991-09-11 |
| MORSE VASCULAR INTRODUCER SET (K912961) | North American Instrument Corp. | 1991-09-11 |
| CASIO BP-100 (K910643) | Casio, Inc. | 1991-09-10 |
| MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM (K912627) | Ppg Industries, Inc. | 1991-09-10 |
| ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI (K912554) | Baxter Healthcare Corp | 1991-09-09 |
| ACS RX SUPPORT CATHETER (K911957) | Advanced Cardiovascular Systems, Inc. | 1991-09-06 |
| HEART TECHNOLOGY ROTABLATOR WIRECLIP (K913450) | Heart Technology, Inc. | 1991-09-06 |
| ACCUCORE TELEMETRY, MODIFICATION (K905506) | S & W Medico Teknik | 1991-09-06 |
| SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE (K912156) | Schneider Intl., Ltd. | 1991-09-06 |
| MEGA PERICARDIOCENTESIS KIT (K912564) | Mega Medical, Inc. | 1991-09-05 |
| CARDIOCAP II(TM) (K912530) | Datex Medical Instrumentation, Inc. | 1991-09-05 |
| MODEL #810 STEALTH-STIM ADULT STIMULATION PADS (K913226) | Cardiotronics, Inc. | 1991-09-04 |
| WARMTOUCH (K913016) | Advanced Warming Systems, Inc. | 1991-09-04 |
| CPI MODEL 2215 & SEAMED MODEL 3400 (K912507) | Seamed Corp. | 1991-09-03 |
| SCIMED 7 FR. & 8 FR. (K913364) | Scimed Life Systems, Inc. | 1991-08-30 |
| LP-PLUS (K903774) | Fidelity Medical, Inc. | 1991-08-29 |
| EDENTEC MODEL 3711 DIGITAL RECORDER (K910870) | Edentec Corp. | 1991-08-29 |
| ESCORT 300 SERIES (K911665) | Medical Data Electronics | 1991-08-29 |
| EDENTEC DIGITAL CHARTER MODEL 3710 (K910871) | Edentec Corp. | 1991-08-29 |
| BARD PERIPHERAL BALLOON DILATATION CATHETER (K910822) | C.R. Bard, Inc. | 1991-08-29 |
| TRACETS SME 5000 (K912450) | Lectec Corp. | 1991-08-28 |
| MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR (K897068) | Medtronic Vascular | 1991-08-28 |
| 100 CM PERMANENT PACING LEAD MODELS (K911273) | Telectronics Pacing Systems, Inc. | 1991-08-28 |
| ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE (K910924) | Pacesetter Systems | 1991-08-28 |
| PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (K910609) | Biotronik, GmbH & Co. | 1991-08-28 |
| THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER (K901281) | Val-Mark Medical, Inc. | 1991-08-28 |
| OXICOMPLUS (K911207) | Waters Instruments, Inc. | 1991-08-26 |
| BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP (K911351) | Biochem International, Inc. | 1991-08-22 |
| MONARCH SYSTEM (K911051) | Baxter Healthcare Corp | 1991-08-22 |
| SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH (K912317) | Schneider Intl., Ltd. | 1991-08-22 |
| MODEL 4220 (K913134) | Pace Medical | 1991-08-22 |
| MODEL SCR-1000 (K913400) | Accucore, Inc. | 1991-08-21 |
| MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT (K911789) | Medtronic Vascular | 1991-08-20 |
| SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION (K912078) | 3M Health Care, Sarns | 1991-08-20 |
| MR-5200 FULL DISCLOSURE SYSTEM (K911257) | Mennen Medical, Inc. | 1991-08-19 |
| OPTI-PLAST 5F PTA CATHETERS (K913112) | Vas-Cath, Inc. | 1991-08-16 |
| DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 (K911166) | Diagnostic Ultrasound Corp. | 1991-08-15 |
| VER-MED A10014 RESTING EKG ELECTRODE & A10021 (K910139) | Vermont Medical, Inc. | 1991-08-15 |
| LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) (K911763) | Vasamedics, LLC | 1991-08-13 |
| DASH IV (K912929) | Astro-Med, Inc. | 1991-08-13 |
| OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (K912984) | Vas-Cath, Inc. | 1991-08-13 |