| K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A (K003228) | Katecho, Inc. | 2000-12-14 |
| NEXAN SYSTEM, MODEL NX-300 (K003520) | Nexan, Ltd. | 2000-12-13 |
| ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 (K002481) | Zcv ,Inc. | 2000-12-07 |
| POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D (K003452) | Ep Technologies, Inc. | 2000-12-07 |
| AEDEFIBRILLATOR (K002232) | Medical Research Laboratories, Inc. | 2000-12-06 |
| MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) (K003483) | Lake Region Mfg., Inc. | 2000-12-06 |
| EECP THERAPY SYSTEM, MODEL TS3 (K003469) | Vasomedical, Inc. | 2000-12-06 |
| DARDIK CAROTID SHUNT (K001621) | Vascutech, Inc. | 2000-12-06 |
| SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (K002105) | Siemens Medical Solutions USA, Inc. | 2000-12-05 |
| WIRECLIP TORQUER (K003398) | Boston Scientific Corporation Northwest Technology | 2000-12-01 |
| TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 (K003276) | NuMED, Inc. | 2000-12-01 |
| DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER (K002493) | Cobe Cardiovascular, Inc. | 2000-11-30 |
| NICOLET VASOGUARD (K002766) | Nicolet Biomedical | 2000-11-30 |
| MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS (K002781) | Medical Cables, Inc. | 2000-11-29 |
| MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 (K002787) | Palco Labs, Inc. | 2000-11-29 |
| ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 (K000004) | Daig Corp. | 2000-11-29 |
| PC ECG 1200 (K000404) | Norav Medical , Ltd. | 2000-11-22 |
| ALPHA OMEGA DUAL COOLER-HEATER (K001520) | Alpha Omega, Inc. | 2000-11-22 |
| DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 (K002047) | Doctor'S Research Group, Inc. | 2000-11-22 |
| K-DEFIB/PACE, MODEL KDP-60A (K002806) | Katecho, Inc. | 2000-11-21 |
| MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR (K003444) | Nihon Seimitsu Sokki Co., Ltd. | 2000-11-21 |
| MICROPAQ, MODELS 402 AND 404 (K002725) | Protocol Systems, Inc. | 2000-11-21 |
| PINNACLE R/O II OR RADIFOCUS INTRODUCER II (K003424) | Terumo Medical Corp. | 2000-11-21 |
| ROSETTA-LT/ROSETTA-RX (K002089) | General Devices | 2000-11-21 |
| TISSUE SPECTROSCOPE (K992529) | Vital Medical , Ltd. | 2000-11-17 |
| FRONT-LOAD POLYPROPYLENE SYRINGE (K001663) | Medrad, Inc. | 2000-11-16 |
| WELCH ALLYN SPOT CHECK DEVICE (K002530) | Welch Allyn, Inc. | 2000-11-14 |
| ALLON 2001 MODIFIED (K003349) | Mtre Advanced Technology , Ltd. | 2000-11-13 |
| ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 (K002687) | Zynergy Cardiovascular, Inc. | 2000-11-09 |
| SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM (K003179) | Siemens Medical Solutions USA, Inc. | 2000-11-09 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K003167) | Masimo Corp. | 2000-11-08 |
| WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES (K002473) | Nihon Kohden America, Inc. | 2000-11-08 |
| PERSONAL ECG TRANSMITTER, MODEL CG-6550 (K003220) | Card Guard Scientific Survival , Ltd. | 2000-11-08 |
| PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING (K002707) | Precision Vascular Systems, Inc. | 2000-11-08 |
| PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH (K002459) | Agilent Technologies, Inc. | 2000-11-08 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K003244) | Masimo Corp. | 2000-11-08 |
| ETHIBOND EXCEL VALVE LOOP SUTURE (K003070) | ETHICON, Inc. | 2000-11-07 |
| CNS-9300 SERIES CENTRAL STATION (K001433) | Nihon Kohden America, Inc. | 2000-11-07 |
| ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 (K001788) | Erecords Enterprises | 2000-11-03 |
| NUMED TYSHAK AND Z-MED PTV CATHETERS (K003114) | NuMED, Inc. | 2000-11-01 |
| AB-180 XC SYSTEM, MODEL AB-180XC (K991783) | Cardiacassist, Inc. | 2000-11-01 |
| FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H (K003282) | Sein Electronics Co., Ltd. | 2000-11-01 |
| NUMED TYSHAK II AND Z-MED II PTV CATHETERS (K003052) | NuMED, Inc. | 2000-11-01 |
| CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM (K001948) | Hypertension Diagnostics, Inc. | 2000-11-01 |
| CORDIS SLALOM PTA BALLOON CATHETER (K003159) | Cordis Corp. | 2000-10-30 |
| RESPONDER 3000 (K000638) | Ge Medical Systems Information Technologies GmbH | 2000-10-30 |
| ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER (K002676) | Guidant Cardiac and Vascular Surgery | 2000-10-30 |
| ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK (K001972) | Visicu, Inc. | 2000-10-27 |
| ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS (K002577) | Medivance, Inc. | 2000-10-26 |
| OSCAR 2, MODEL 222 (K003004) | Suntech Medical Instruments, Inc. | 2000-10-25 |
| CARDIOBEEPER CB12/12, MODEL CB12/12 (K002310) | Meridian Medical Technologies , Ltd. | 2000-10-25 |
| LIFE SCOPE P, MODEL BSM-4100 SERIES (K001693) | Nihon Kohden America, Inc. | 2000-10-24 |
| MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC (K002949) | Datascope Corp. | 2000-10-20 |
| M2376A DEVICELINK SYSTEM (K003107) | Agilent Technologies, Inc. | 2000-10-19 |
| SOLAR SPO2 MODULE WITH MASIMO SET (K002957) | General Electric Medical Systems Information Techn | 2000-10-18 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K002967) | Agilent Technologies, Inc. | 2000-10-18 |
| PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (K002204) | Pace Medical | 2000-10-18 |
| GUNTHER TULIP VENA CAVA MREYE FILTER SET (K000855) | Cook, Inc. | 2000-10-18 |
| EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 (K002534) | Eupalamus, LLC | 2000-10-18 |
| SAFE MINI (K980974) | Polystan A/S | 2000-10-13 |
| ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER (K001578) | AngioDynamics, Inc. | 2000-10-13 |
| HL168B (K002882) | Health & Life Co., Ltd. | 2000-10-13 |
| MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 (K002690) | Nonin Medical, Inc. | 2000-10-11 |
| MODEL 4810 ANALYZER OUTPUT ADAPTER (K002497) | Pace Medical | 2000-10-10 |
| MODEL 4815 ADAPTER (K002496) | Pace Medical | 2000-10-10 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER (K002939) | Masimo Corp. | 2000-10-06 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002751) | Masimo Corp. | 2000-10-05 |
| S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 (K002478) | Datex-Ohmeda, Inc. | 2000-10-05 |
| ELS CANNULA (KIT), MODEL M1210-88,M1510-88 (K002857) | Jostra AG | 2000-10-05 |
| CATHCOR DESKTOP (K002137) | Siemens Elema AB | 2000-10-05 |
| PRESSURE WIRE SENSOR, MODEL 12003/12303 (K002962) | Radi Medical Systems AB | 2000-10-04 |
| INQWIRE DIAGNOSTIC GUIDE WIRE (K002289) | Merit Medical Systems, Inc. | 2000-10-04 |
| AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES (K002074) | H&C Medical Devices Spa | 2000-10-04 |
| REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA (K002723) | Micro Therapeutics, Inc. | 2000-09-28 |
| TYSHAK, MODEL 102 AND Z-MED, MODEL 302 (K991977) | NuMED, Inc. | 2000-09-27 |
| WIRE, GUIDE, CATHETER, MODEL QSW1000 (K002346) | Medtronic Ave, Inc. | 2000-09-27 |
| COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE (K002767) | Semler Technologies, Inc. | 2000-09-27 |
| BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D (K001244) | Citizen Watch Co., Ltd. | 2000-09-26 |
| OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 (K000512) | Cas Medical Systems, Inc. | 2000-09-26 |
| CLOUD CUFF (K002360) | Parts Port, Ltd. | 2000-09-26 |
| OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES (K002030) | Invivo Research, Inc. | 2000-09-26 |
| CONSTELLATION CATHETERS (K000277) | Boston Scientific Corp | 2000-09-26 |
| ILT 0.014 CATHETER, MODEL C114NL2 (K001992) | Intra Luminal Therapeutics, Inc. | 2000-09-25 |
| VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES (K001926) | Thoratec Laboratories Corp. | 2000-09-22 |
| ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION (K002029) | Zoll Medical Corp | 2000-09-21 |
| DINAMAP PRO 1000 MONITOR, MODEL 1000 (K002248) | Critikon Company, LLC | 2000-09-21 |
| 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER (K000825) | Medi-Dyne, Inc. | 2000-09-21 |
| ZYBIT (K002004) | Zymed Medical Instrumentation | 2000-09-21 |
| VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS (K000664) | Baxter Healthcare Corp | 2000-09-20 |
| HL168T (K002750) | Health & Life Co., Ltd. | 2000-09-18 |
| QUEST MPS BACK-UP SYSYEM (K002366) | Quest Medical, Inc. | 2000-09-18 |
| ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 (K001842) | Somanetics Corp. | 2000-09-15 |
| NICORE MODEL ESP -1 (K980937) | Nicore Equipment & Leasing, Inc. | 2000-09-15 |
| COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K002591) | Cobe Cardiovascular, Inc. | 2000-09-13 |
| MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM (K002544) | Oxford Instruments | 2000-09-13 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002682) | Masimo Corp. | 2000-09-13 |
| PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (K992476) | Pilling Weck Surgical | 2000-09-13 |
| GOLDEN-RULE SCALING CATHETER (K002416) | Medical Device Technologies, Inc. | 2000-09-11 |
| DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 (K002722) | Jawon Medical Co., Ltd. | 2000-09-11 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002477) | Masimo Corp. | 2000-09-08 |