| ACIST ANGIOGRAPHIC INJECTOR (K963982) | Invasatec | 1997-12-05 |
| CARDIOCALL CARDIAC EVENT RECORDER (K972649) | Reynolds Medical , Ltd. | 1997-12-04 |
| RHYTHMSTAT XL (K971650) | Data Critical Corp. | 1997-12-04 |
| HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES (K973437) | Hewlett-Packard GmbH | 1997-12-03 |
| BODYSTAT (K971554) | Bodystat , Ltd. | 1997-11-26 |
| MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) (K973230) | Merit Medical Systems, Inc. | 1997-11-25 |
| FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) (K973216) | Rmds, Inc. | 1997-11-25 |
| CERTODYN RAECG UNIVERSAL ADAPTER (K973371) | B.Braun Medical, Inc. | 1997-11-24 |
| FLUORO-TEX SURGICAL MEMBRANE (K973178) | Bridger Biomed, Inc. | 1997-11-24 |
| CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) (K973475) | Medtronic Vascular | 1997-11-20 |
| RENEGADE FIBER BRAIDED MICROCATHETER (K973645) | Boston Scientific Corp | 1997-11-19 |
| LMI IRRIGATION CATHETER (IGR) (K972623) | Lucas Medical, Inc. | 1997-11-19 |
| BLUE MAX - 20 BALLOON DILATATION CATHETER (K972357) | Boston Scientific Corp | 1997-11-19 |
| TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) (K973401) | Cordis Corp. | 1997-11-18 |
| SAFPACE SYSTEM (K955829) | B.Braun Medical, Inc. | 1997-11-18 |
| HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING (K970938) | Biocompatibles Cardiovascular, Inc. | 1997-11-17 |
| IBC CARDIAC SUCTION WARD (K963756) | International Biophysics Corp. | 1997-11-14 |
| NPB-295 PULSE OXIMETER (K973147) | Nellcor Puritan Bennett, Inc. | 1997-11-14 |
| IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM (K971868) | Marquette Electronics, Inc. | 1997-11-13 |
| BCI MODEL 6004 NIBP MONITOR (6004) (K970801) | Bci Intl., Inc. | 1997-11-12 |
| HEART ACCESS PLUS CARDIAC EVENT RECORDER (K973141) | Paceart, Inc. | 1997-11-12 |
| ACUITY CENTRAL STATION (K972121) | Protocol Systems, Inc. | 1997-11-07 |
| LIFEPAK 300 (K962359) | Physio-Control Corp. | 1997-11-06 |
| (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH (K962473) | Data Critical Corporation | 1997-11-06 |
| QUEST VESSEL CATHETER (K971928) | Quest Medical, Inc. | 1997-11-06 |
| DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER (K973007) | Datascope Corp. | 1997-11-06 |
| 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K972962) | 3M Company | 1997-11-06 |
| TRINITY DVT SYSTEM (K963957) | Delphi Consulting Group | 1997-11-04 |
| TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER (K972518) | Cordis Neurovascular, Inc. | 1997-11-04 |
| PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) (K970853) | Cardima, Inc. | 1997-11-04 |
| THEROX INFUSION GUIDEWIRES (K971719) | Therox, Inc. | 1997-11-03 |
| MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT (K972944) | Medtronics Interventional Vascular | 1997-11-03 |
| RETRIEVER II (K964210) | Target Therapeutics | 1997-10-31 |
| GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE (K963368) | Glycar, Inc. | 1997-10-31 |
| GLYCAR PERICARDIAL PATCH (K963967) | Glycar, Inc. | 1997-10-31 |
| CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT (K970638) | Cardiothoracic Systems, Inc. | 1997-10-30 |
| CHASE TEMPERATURE PROBE (K971013) | Chase Medical, Inc. | 1997-10-28 |
| CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM (K970264) | Cordis Webster, Inc. | 1997-10-28 |
| CRICKET 2000 RECORDING PULSE OXIMETER (K972829) | Respironics, Inc. | 1997-10-28 |
| EDEMA SYSTEM (K962783) | Bioanalogics, Inc. | 1997-10-23 |
| VIKING DIAGNOSTIC ELECTRODE CATHETER (K971265) | C.R. Bard, Inc. | 1997-10-23 |
| MDP2000 MEDICAL DATA PROCESSOR (K972880) | Vidco, Inc. | 1997-10-22 |
| WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET (K971683) | Marquette Electronics, Inc. | 1997-10-22 |
| NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES (K971436) | Nihon Kohden America, Inc. | 1997-10-21 |
| VISTA BRITE TIP GUIDING CATHETERS (K972978) | Cordis Corp. | 1997-10-21 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 (K972746) | Alexander Mfg. Co. | 1997-10-21 |
| NPB-290 PULSE OXIMETER (NPB-290) (K972837) | Nellcor Puritan Bennett, Inc. | 1997-10-21 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 (K972789) | Alexander Mfg. Co. | 1997-10-17 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 (K972786) | Alexander Mfg. Co. | 1997-10-17 |
| SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM (K972714) | Siemens Medical Solutions USA, Inc. | 1997-10-17 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P (K972787) | Alexander Mfg. Co. | 1997-10-17 |
| HARMAC BALLOON WEDGE PRESSURE CATHETER (K963335) | Harmac Medical Products, Inc. | 1997-10-16 |
| POWERHEART AECD (K970741) | Cardiac Science, Inc. | 1997-10-16 |
| HARMAC BALLOON ANGIOGRAPHIC CATHETER (K962829) | Harmac Medical Products, Inc. | 1997-10-16 |
| HARMAC TEMPORARY PACING CATHETER WITH BALLOON (K962833) | Harmac Medical Products, Inc. | 1997-10-15 |
| CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES (K972762) | Cardio Metrics, Inc. | 1997-10-14 |
| INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (K972684) | Innerdyne, Inc. | 1997-10-10 |
| SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) (K971628) | Somanetics Corp. | 1997-10-10 |
| MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS (K965112) | Medline Industries, Inc. | 1997-10-10 |
| RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE (K971281) | Medcomp | 1997-10-09 |
| GELBFISH ENDO-VAC SYSTEM (K970233) | Gary A. Gelbfish | 1997-10-08 |
| INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (K971273) | Bio-Tek Instruments, Inc. | 1997-10-08 |
| COEUR 130 ML ANGIOGRAPHIC SYRINGE (K971712) | Coeur Laboratories, Inc. | 1997-10-08 |
| MANIFOLD (K972654) | Medical Specialties Intl., Inc. | 1997-10-08 |
| LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR (K971877) | Dideco S.P.A. | 1997-10-08 |
| FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR (K971131) | Fukuda Denshi USA, Inc. | 1997-10-03 |
| NIVP3 (WINDOWS VERSION OF NIVP (K970570) | D. E. Hokanson, Inc. | 1997-10-03 |
| THUMPER (K972525) | Michigan Instruments, Inc. | 1997-10-02 |
| HEARTPORT INTRODUCER SHEATH (K972570) | Heartport, Inc. | 1997-10-01 |
| 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER (K970854) | Cordis Corp. | 1997-09-30 |
| COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS (K964043) | Cobe Cardiovascular, Inc. | 1997-09-29 |
| ACS VIKING GUIDING CATHETER (K972484) | Guidant Corp. | 1997-09-26 |
| 3M LITTMANN ELECTRONIC STETHOSCOPE (K961848) | Minnesota Mining and Mfg. Co. | 1997-09-26 |
| HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) (K972418) | Heartstream, Inc. | 1997-09-25 |
| ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) (K970061) | Datascope Corp. | 1997-09-25 |
| SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (K972199) | Marquette Electronics, Inc. | 1997-09-25 |
| SPACELABS MEDICAL PCIS PATIENT MONITORS (K972282) | Spacelabs Medical, Inc. | 1997-09-25 |
| NPB-195 PULSE OXIMETER (K972468) | Nellcor Puritan Bennett, Inc. | 1997-09-25 |
| KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE (K971038) | Kontron Instruments , Ltd. | 1997-09-24 |
| SANAPHON N (K972378) | Rudolf Riester GmbH & Co. KG | 1997-09-24 |
| PRECISA N (K972379) | Rudolf Riester GmbH & Co. KG | 1997-09-24 |
| RI-MEGA (K972377) | Rudolf Riester GmbH & Co. KG | 1997-09-24 |
| SHELHIGH PERICARDIAL PATCH (K964467) | Shelhigh, Inc. | 1997-09-23 |
| ANGIOMAT ILLUMENA (K963071) | Mallinckrodt Inc., Liebel-Flarsheim Business | 1997-09-23 |
| DINAMAP MPS PORTABLE MONITOR (K971569) | Johnson & Johnson Medical, Inc. | 1997-09-19 |
| AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) (K971984) | Microvena Corp. | 1997-09-19 |
| BIG BEN SQUARE, BIG BEN ROUND (K972301) | Rudolf Riester GmbH & Co. KG | 1997-09-17 |
| ACS HI-TORQUE RULER GUIDE WIRE (K972290) | Guidant Corp. | 1997-09-17 |
| 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S (K963865) | Arrow Intl., Inc. | 1997-09-16 |
| RIVETTI-LEVINSON INSTRALUMINAL SHUNT (K972261) | Integra Neurocare, LLC | 1997-09-15 |
| TELE TRENS TM 10 (K960884) | Life Sensing Instrument Company, Inc. | 1997-09-12 |
| SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM (K964624) | Siemens Medical Solutions USA, Inc. | 1997-09-11 |
| BIOZ SYSTEM & BIOZ PORTABLE (K972320) | Cardiodynamics International Corp. | 1997-09-11 |
| BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) (K972017) | Minntech Corp. | 1997-09-10 |
| S3 CYCLIC RPM CONTROL (K971520) | Stoeckert Instrumente | 1997-09-10 |
| MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED) (K963725) | Card Guard , Ltd. | 1997-09-10 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR (K970585) | Fukuda Denshi USA, Inc. | 1997-09-09 |
| AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS (K964238) | Aircast, Inc. | 1997-09-08 |
| CHASE THORACIC CATHETER (K971023) | Chase Medical, Inc. | 1997-09-08 |
| SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K973222) | Siemens Medical Solutions USA, Inc. | 1997-09-04 |