| MEADOX EXXCEL EPTFE VASCULAR GRAFT (K962433) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-17 |
| HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) (K963174) | Del Mar Avionics | 1997-03-13 |
| MS-2000 (K961144) | Touritu Engineering Co., Inc. | 1997-03-12 |
| HEARTPORT NEEDLE TROCAR (K965051) | Heartport, Inc. | 1997-03-12 |
| EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM (K963787) | Conmedcorp | 1997-03-11 |
| VESSEL DILATOR (K963388) | Maxxim Medical | 1997-03-11 |
| VISTA BRITE TIP CATHETERS (K965211) | Cordis Corp. | 1997-03-11 |
| VASCUTEK TWILLWEAVE VASCULAR GRAFT (K964959) | Vascutek, Ltd. | 1997-03-10 |
| GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR (K964973) | Gish Biomedical, Inc. | 1997-03-10 |
| BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION (K964604) | Biotronik, Inc. | 1997-03-10 |
| MODEL 700 (K944180) | Memtec Corp. | 1997-03-07 |
| CARDIOSERV P (K962547) | Marquette Electronics, Inc. | 1997-03-06 |
| QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES (K970391) | Contour Medical Technology, Inc. | 1997-03-06 |
| BIOCOR 200 HIGH PERFORMANCEOXYGENATOR (K964967) | Minntech Corp. | 1997-03-06 |
| PS-41 6M PATIENT SIMULATOR (K963198) | Metron U.S., Inc. | 1997-03-05 |
| NOAH MONITORING ELECTRODE SYSTEM (K970125) | Contour Medical Technology, Inc. | 1997-03-04 |
| CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE (K965023) | Scimed Life Systems, Inc. | 1997-03-04 |
| OXIMETRIX 4 COMPUTER SYSTEM (K961661) | Abbott Laboratories | 1997-03-04 |
| CARDIACMONITOR (K963375) | Vision Electronics | 1997-02-28 |
| HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II (K964888) | Tz Medical, Inc. | 1997-02-28 |
| MOBILE MEDICAL MONITOR (M3(A)) (K963576) | Scientific Applications | 1997-02-28 |
| RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120) | Marquette Electronics, Inc. | 1997-02-28 |
| BERENSTEIN COIL (K964112) | Target Therapeutics | 1997-02-26 |
| CAPIOX SP PUMP HEAD (K962981) | Terumo Medical Corp. | 1997-02-25 |
| ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (K962827) | Marquette Electronics, Inc. | 1997-02-24 |
| CARETONE II (K963678) | American Telecare, Inc. | 1997-02-24 |
| SPYGLASS ANGIOGRAPHIC CATHETER (K965249) | Daig Corp. | 1997-02-21 |
| CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) (K962765) | Cordis Corp. | 1997-02-21 |
| FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) (K964055) | Epic Medical Equipment Services, Inc. | 1997-02-21 |
| MAXI LD PTA BALLOON CATHETER (K963000) | Cordis Corp. | 1997-02-20 |
| VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (K964665) | Carbomedics, Inc. | 1997-02-19 |
| PROTECT ALL BLOOD PRESSURE CUFF COVER (K964648) | Protect All, Inc. | 1997-02-18 |
| SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M (K961246) | St. Jude Medical, Inc. | 1997-02-14 |
| 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING (K962717) | Biocompatibles Cardiovascular, Inc. | 1997-02-12 |
| AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION (K964697) | Advance Medical Device, Inc. | 1997-02-11 |
| 8500A PULSE OXIMETER (K945290) | Nonin Medical, Inc. | 1997-02-11 |
| SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K964859) | Scimed Life Systems, Inc. | 1997-02-10 |
| HEARTPORT ENDOVENOUS DRAINAGE CANNULA (K962835) | Heartport, Inc. | 1997-02-10 |
| AS/3 ESTPR MODULE (K953175) | Datex Division Instrumentarium Corp. | 1997-02-06 |
| MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES (K962603) | Masimo Corp. | 1997-02-06 |
| SAFE MICRO (K953976) | Polystan A/S | 1997-02-04 |
| 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM (K963104) | Arrow Intl., Inc. | 1997-02-04 |
| FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 (K964662) | Rmds, Inc. | 1997-02-03 |
| FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) (K963248) | J-Lloyd Medical, Inc. | 1997-02-03 |
| CHASE VESSEL OCCLUDER (K964390) | Chase Medical, Inc. | 1997-01-31 |
| OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (K964445) | Dlp, Inc. | 1997-01-30 |
| PATHFINDER (K955802) | Cardima, Inc. | 1997-01-29 |
| SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM (K962291) | Siemens Medical Solutions USA, Inc. | 1997-01-29 |
| PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM (K922668) | Colin Medical Instruments Corp. | 1997-01-29 |
| GYRO TIP EP CATHETER (K955847) | Cardiac Assist Devices, Inc. | 1997-01-29 |
| TRANSEND GUIDEWIRE (K964611) | Boston Scientific Corp | 1997-01-28 |
| TORQUE DEVICE (K964352) | B.Braun Medical, Inc. | 1997-01-28 |
| SOF. PRESS EPC 51 SYSTEM (K963067) | Gaymar Industries, Inc. | 1997-01-28 |
| JOBST ATHROMBIC PUMP SYSTEM 2100 (K963929) | Jobst A Beiersdorf Co. | 1997-01-27 |
| ANEROID AND MERCURIAL SPHYGMOMANOMETERS (K962655) | American Diagnostic Corp. | 1997-01-27 |
| PERCUPUMP II WITH EDA (K961845) | E-Z-Em, Inc. | 1997-01-23 |
| PERFORMR SERIES EP DIAGNOSTIC CATHETERS (K964272) | Medtronic Cardiorhythm | 1997-01-23 |
| BRENTWOOD PC-ECG (K955023) | Brentwood Medical Products, Inc. | 1997-01-22 |
| HEARTPORT ENDOCORONARY SINUS CATHETR (K964248) | Heartport, Inc. | 1997-01-22 |
| HEMASHIELD VANTAGE (VASCULAR GRAFT (K961847) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-01-22 |
| ACS HI-TORQUE IRON MAN GUIDE WIRE (K963702) | Advanced Cardiovascular Systems, Inc. | 1997-01-22 |
| SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM (K962404) | Siemens Medical Solutions USA, Inc. | 1997-01-17 |
| 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES (K964991) | Cardiotronics Systems, Inc. | 1997-01-15 |
| SEGUE INFUSION CATHETER (K964154) | Interventional Innovations Corp. | 1997-01-14 |
| 11F GUIDING CATHETER (K963663) | Boston Scientific /International Technologies | 1997-01-13 |
| ASC HIGH PRESSURE BRAIDED TUBES (K964331) | Adam Spencer Corp. | 1997-01-13 |
| VERSA-CATH ARTERIAL CATHETER (K961883) | Ideas For Medicine, Inc. | 1997-01-13 |
| GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET (K960511) | Gibeck, Inc. | 1997-01-13 |
| MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER (K963092) | Adam Spencer Corp. | 1997-01-13 |
| S3 CARDIOPLEGIA CONTROL (K962320) | Stoeckert Instrumente | 1997-01-10 |
| HP STAR ST AND ARRHHYTHMIA SOFTWARE (K964122) | Hewlett-Packard Co. | 1997-01-08 |
| DEGANIA SILICONE INDENTI LOOPS (K964547) | Degania Silicone , Ltd. | 1997-01-08 |
| CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM (K962978) | Johnson & Johnson Medical, Inc. | 1997-01-07 |
| VERSATEC 310 ELECTRODE (K963975) | Versatec, Inc. | 1997-01-07 |
| MODEL 90022 ROLLING STAND (K963672) | Augustine Medical, Inc. | 1997-01-06 |
| STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM (K964284) | Boston Scientific Corp | 1997-01-06 |
| IMPRA CARBOFLO EPTFE VASCULAR GRAFT (K964197) | Impra, Inc. | 1997-01-02 |
| NEEDLE'S EYE SNARE (K961992) | Cook Pacemaker Corp. | 1996-12-27 |
| ALBA HEALTH PAS WRAP SYSTEM (K961405) | Alba-Waldensian, Inc. | 1996-12-26 |
| HEMODIALYSIS INTRODUCER SET (K961780) | Thomas Medical Products, Inc. | 1996-12-24 |
| NPB-4000 (K962424) | Analogic Corp. | 1996-12-20 |
| SCIMED CHOICE PT VISION PTCA GUIDE WIRE (K962572) | Scimed Life Systems, Inc. | 1996-12-17 |
| PERSONAL TELEMEDICINE MODULE (K964554) | American Telecare, Inc. | 1996-12-17 |
| HYDRO-SELECT GUIDEWIRE (K954642) | Microvena Corp. | 1996-12-17 |
| HIGH PRESSURE INJECTION LINES (K963749) | Maxxim Medical | 1996-12-17 |
| MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER (K962641) | Medtronic Vascular | 1996-12-16 |
| MODEL 430-07 ENDOCARDIAL PACING LEAD (K954610) | Intermedics, Inc. | 1996-12-16 |
| NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) (K963707) | Nellcor Puritan Bennett, Inc. | 1996-12-13 |
| INTRAVASCULAR INFUSION DEVICE (K963988) | Boston Scientific Corp | 1996-12-12 |
| 700-F SERIES STIMULATION ELECTRODES (K964469) | Cardiotronics Systems, Inc. | 1996-12-11 |
| CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES (K963159) | Cmc Sense-It, Inc. | 1996-12-11 |
| ESORT II + 400 SERIES MONITOR (K961138) | Medical Data Electronics | 1996-12-10 |
| MEDICOTEST ECG ELECTRODES (K961643) | Medicotest, Inc. | 1996-12-09 |
| SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM (K961937) | Delphi Consulting Group | 1996-12-09 |
| GISH RELIANCE OXYGENATOR (MODEL HFO) (K961530) | Gish Biomedical, Inc. | 1996-12-05 |
| STETHOS (K963621) | Theratechnologies, Inc. | 1996-12-04 |
| SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE (K952315) | Emg Scientific | 1996-12-04 |
| CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (K963811) | Card Guard Scientific Survival , Ltd. | 1996-12-04 |
| TFX MEDICAL GUIDEWIRE (K963320) | Tfx Medical Group | 1996-12-03 |
| POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P (K960970) | Possis Medical, Inc. | 1996-12-03 |