| DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE (K011361) | Catheffects, LLC | 2001-09-06 |
| VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER (K012050) | Guidant Corp. | 2001-09-06 |
| MICROCRUISER PLUS INTRODUCER SET (K011790) | Medical Device Technologies, Inc. | 2001-09-05 |
| DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 (K012392) | Pace Medical | 2001-09-04 |
| PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS (K003548) | Padpro, LLC | 2001-09-04 |
| NEXAN SYSTEM, MODEL NX-301 (K010424) | Nexan, Ltd. | 2001-09-04 |
| ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 (K012169) | Intra Luminal Therapeutics, Inc. | 2001-08-30 |
| MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 (K012489) | Appriva Medical, Inc. | 2001-08-30 |
| SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 (K011729) | Dni Nevada, Inc. | 2001-08-30 |
| SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 (K003804) | Niko Medical Products | 2001-08-30 |
| ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM (K012130) | Medtronic Vascular | 2001-08-28 |
| SNIPER ELITE MODEL-OR-E3872XX SERIES (K011905) | Maxxim Medical | 2001-08-28 |
| ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 (K012083) | Medtronic Vascular | 2001-08-28 |
| ATTAIN 6215 VENOGRAM BALLOON CATHETER (K012225) | Medtronic Vascular | 2001-08-28 |
| NEUROEDGE INFUSION CATHETER (K011646) | Neuro Vasx, Inc. | 2001-08-27 |
| LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K010918) | Medtronic Physio-Control Corp. | 2001-08-23 |
| TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE (K012538) | Medtronic Vascular | 2001-08-23 |
| MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR (K012310) | Health & Life Co., Ltd. | 2001-08-22 |
| MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES (K012533) | Osi Medical, Inc. | 2001-08-22 |
| MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE (K011811) | Merit Medical Systems, Inc. | 2001-08-22 |
| MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR (K011991) | Medrad, Inc. | 2001-08-21 |
| RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC (K012020) | Non-Invasive Monitoring Systems, Inc. | 2001-08-21 |
| KSEA DION-GRACIA SET (K010785) | KARL STORZ Endoscopy-America, Inc. | 2001-08-21 |
| WECK CARDIAC PACING WIRES (K011660) | Weck Closure Systems | 2001-08-21 |
| QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 (K011339) | Spacelabs Burdick, Inc. | 2001-08-20 |
| PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 (K012451) | Welch Allyn Protocol, Inc. | 2001-08-20 |
| GSIBP BLOOD PRESSURE CUFF (K012553) | Globalshop, Inc. | 2001-08-17 |
| WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM (K012455) | Welch Allyn, Inc. | 2001-08-17 |
| SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER (K012461) | Siemens Medical Solutions USA, Inc. | 2001-08-17 |
| ABN ANEROID SPHYGMOMANOMETER (K012444) | Pt. Sugih Instrumendo Abadi | 2001-08-16 |
| MODIFICATION TO ENVOY PATIENT MONITOR (K011784) | Mennen Medical , Ltd. | 2001-08-16 |
| CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X (K012209) | Terumo Cardiovascular Systems Corp. | 2001-08-15 |
| 3T L. V. CONTROL VALVE (K001245) | 3t Medical Systems, LLC | 2001-08-15 |
| MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD (K012460) | Medtronic Vascular | 2001-08-14 |
| CG-3250 MINIRECEIVER (K012187) | Card Guard Scientific Survival , Ltd. | 2001-08-14 |
| MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD (K012452) | Medtronic Vascular | 2001-08-14 |
| MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD (K012454) | Medtronic Vascular | 2001-08-14 |
| MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD (K012458) | Medtronic Vascular | 2001-08-14 |
| PACEART TX3 CARDIAC EVENT RECORDER (K012407) | Paceart, Inc. | 2001-08-14 |
| MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE (K012459) | Medtronic Vascular | 2001-08-14 |
| BACK-UP MEIER GUIDEWIRE (K011906) | Boston Scientific Corp | 2001-08-13 |
| CHASE CARDIOVASCULAR PATCH (K012248) | Chase Medical, Inc. | 2001-08-10 |
| ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM (K011320) | Hitachi Medical Systems America, Inc. | 2001-08-09 |
| FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 (K012054) | Sein Electronics Co., Ltd. | 2001-08-08 |
| CADENCE PRECISION INJECTOR, MODEL 103-0304 (K011535) | Micro Therapeutics, Inc. | 2001-08-02 |
| MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI (K010413) | Konica Minolta Sensing, Inc. | 2001-08-02 |
| 8100/8500 VITAL SIGNS MONITOR (K012059) | Criticare Systems, Inc. | 2001-08-01 |
| ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (K011865) | Zoll Medical Corp | 2001-07-31 |
| BRAUN PRECISION SENSOR PRO, MODEL BP 2590 (K012035) | Braun GmbH | 2001-07-27 |
| VIKING OPTIMA GUIDING CATHETER (K012002) | Guidant Corp. | 2001-07-26 |
| STREERABLE PTCA GUIDEWIRE (K011968) | Lake Region Mfg., Inc. | 2001-07-25 |
| MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K012005) | Data Critical Corp. | 2001-07-24 |
| MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS (K012171) | Visicu, Inc. | 2001-07-24 |
| MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM (K011999) | Data Critical Corp. | 2001-07-24 |
| CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM (K011345) | Reynolds Medical , Ltd. | 2001-07-20 |
| INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II (K012016) | Siemens Medical Solutions USA, Inc. | 2001-07-20 |
| ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS (K011539) | Rossmax International , Ltd. | 2001-07-20 |
| NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 (K011310) | Nien Made Electrnics Corp. | 2001-07-20 |
| ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS (K011352) | Rossmax International , Ltd. | 2001-07-20 |
| BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 (K012194) | Nihon Seimitsu Sokki Co., Ltd. | 2001-07-20 |
| MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A (K012094) | Agilent Technologies, Inc. | 2001-07-20 |
| SPLITTABLE SHEATH INTRODUCER KIT (K004025) | Thomas Medical Products, Inc. | 2001-07-19 |
| ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE (K011847) | Zynergy Cardio Vasular (Zcv), Inc. | 2001-07-13 |
| MALLEABLE SHAFT CLAMP (K011078) | Allegiance Healthcare Corp. | 2001-07-13 |
| LIFECARD CF 7 DAY (K011837) | Reynolds Medical , Ltd. | 2001-07-13 |
| AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM (K011779) | Avid Care Corp. | 2001-07-13 |
| LIFESOURCE MODELS UA-787, UA 787PC, UA-787T (K012013) | A&D Engineering, Inc. | 2001-07-13 |
| MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B (K011395) | Medtronic Vascular | 2001-07-12 |
| PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS (K011557) | NuMED, Inc. | 2001-07-12 |
| VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 (K003551) | Jostra AG | 2001-07-11 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K011851) | Masimo Corp. | 2001-07-11 |
| GUIDEWIRE INTRODUCER SAFETY NEEDLE (K011085) | Medamicus, Inc. | 2001-07-09 |
| BRAIDED GUIDING INTRODUCER (K004026) | Thomas Medical Products, Inc. | 2001-07-09 |
| TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B (K011864) | Medtronic Vascular | 2001-07-09 |
| CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X (K011804) | Terumo Cardiovascular Systems Corp. | 2001-07-09 |
| MOBILE-PATIENT VIEWER (K011436) | Data Critical Corporation | 2001-07-05 |
| 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX (K011734) | Mogul Enterprises | 2001-07-03 |
| BIOZTECT SENSOR AND BIOZTECT CABLE (K011797) | Cardiodynamics International Corp. | 2001-07-03 |
| BODYSTAT (K002835) | Bodystat , Ltd. | 2001-07-03 |
| 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 (K011766) | St Jude Medical | 2001-07-03 |
| AGILENT M2636B TELEMON B MONITOR (TELEMON B) (K011824) | Agilent Technologies, Inc. | 2001-07-02 |
| HOME HEALTH MONITORING SYSTEM (K010029) | Avid Care Corp. | 2001-06-29 |
| TRAM 2001 MODULE (K011000) | General Electric Medical Systems Information Techn | 2001-06-29 |
| HOMMED OBSERVER, MODEL I (K003180) | Hommed, LLC | 2001-06-28 |
| AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 (K003999) | American Telecare, Inc. | 2001-06-28 |
| MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS (K011831) | Denver Biomedical, Inc. | 2001-06-28 |
| DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE (K011670) | Datex-Ohmeda | 2001-06-26 |
| FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 (K010838) | Jomed AG | 2001-06-21 |
| 6F MACH 1, MODEL 34356-XXX (K010874) | Boston Scientific Corp | 2001-06-21 |
| HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 (K011656) | Micro Therapeutics, Inc. | 2001-06-20 |
| RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET (K010974) | Sorin Group Italia S.R.L. | 2001-06-18 |
| CORDIS M3 PTA DILATATION CATHETER (K003920) | Cordis Corp. | 2001-06-15 |
| PORTABLE INSTENSIVE CARE UNIT (K010207) | Medical Research Laboratories, Inc. | 2001-06-14 |
| PULSECO HEMODYNAMIC MONITOR CM71 (K010049) | Lidco, Ltd. | 2001-06-14 |
| ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 (K011523) | Rossmax International , Ltd. | 2001-06-14 |
| BCI 3403 SLEEP SCREENING PULSE OXIMETER (K011156) | Bci, Inc. | 2001-06-14 |
| COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH (K010055) | Cook Vascular, Inc. | 2001-06-14 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 (K011526) | Micro Therapeutics, Inc. | 2001-06-14 |
| AVIATOR PERIPHERAL DILATATION CATHETER (K010831) | Guidant Corp. | 2001-06-13 |
| RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN (K011464) | Vascular Intervention | 2001-06-13 |