| MODIFICATION TO M2376A DEVICELINK SYSTEM (K021347) | Philips Medical Systems | 2002-05-07 |
| 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (K020365) | 3t Medical Systems, LLC | 2002-05-03 |
| LV-1 HEMOSTASIS VALVE, MODEL #6789 (K021282) | Guidant Corp. | 2002-05-02 |
| GUIDANT BALLOON CATHETER, SEVERAL MODELS (K021283) | Guidant Corp. | 2002-05-02 |
| TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH (K013484) | Stereotaxis, Inc. | 2002-05-02 |
| TRANSSEPTAL NEEDLE/TROCAR (K011727) | Thomas Medical Products, Inc. | 2002-05-02 |
| EASYTRAK GUIDING CATHETER (K021284) | Guidant Corp. | 2002-05-02 |
| JOGUIDE CARDIOVASCULAR GUIDING C ATHETER (K021088) | Jomed Catheter, Inc. | 2002-05-02 |
| HI-TORQUE EXTRA S'PORT GUIDEWIRE (K021285) | Guidant Corp. | 2002-05-02 |
| RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP (K021120) | Arrow Intl., Inc. | 2002-05-02 |
| AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217) | Biotronik, Inc. | 2002-05-01 |
| KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS (K011859) | Klimamed Technologie Medizingerate GmbH | 2002-05-01 |
| KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN (K012614) | Medical Instruments Technology, Inc. | 2002-05-01 |
| BCI 3180 PULSE OXIMETER (K020350) | Bci, Inc. | 2002-04-30 |
| GLOBAL ECG MANAGEMENT SYSTEM (GEMS) (K020366) | Cardiocomm Solutions, Inc. | 2002-04-30 |
| ACIST PLUS 4 ANGIOGRAPHIC CATHETER (K021015) | Acist Medical Systems | 2002-04-26 |
| 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 (K013517) | Medtronic Vascular | 2002-04-25 |
| PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES (K020708) | Philips Medical Systems, Inc. | 2002-04-25 |
| COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE (K010128) | Cook Vascular, Inc. | 2002-04-25 |
| ATRION MEDICAL QL FLUID DISPENSING SYRINGE (K020333) | Atrion Medical Products, Inc. | 2002-04-25 |
| JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (K020515) | Jostra AG | 2002-04-24 |
| DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S (K020257) | Datascope Corp. | 2002-04-24 |
| ANNULOFLO SYSTEM, MITRAL MODEL AR700 (K021051) | Sulzer Carbomedics, Inc. | 2002-04-23 |
| WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 (K020604) | Nellcor Puritan Bennett, Inc. | 2002-04-23 |
| HOMMED CENTRAL STATION (K020184) | Hommed, LLC | 2002-04-22 |
| MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS (K021213) | Boston Scientific Corp | 2002-04-19 |
| EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 (K020864) | Edwards Lifesciences, LLC | 2002-04-17 |
| SPYGLASS 4 FR ANGIOGRAPHICY CATHETER (K020890) | St Jude Medical | 2002-04-17 |
| HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP (K012650) | Hygia Health Services, Inc. | 2002-04-12 |
| LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE (K011903) | Vivometrics, Inc. | 2002-04-12 |
| HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP (K012657) | Hygia Health Services, Inc. | 2002-04-12 |
| HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 (K012654) | Hygia Health Services, Inc. | 2002-04-12 |
| HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 (K012651) | Hygia Health Services, Inc. | 2002-04-12 |
| ABP-2000 G-3 (K021029) | Biotrac, Inc. | 2002-04-12 |
| AXILLARY ACCESS ARTERIAL CANNULA (K002578) | Edwards Lifesciences, LLC | 2002-04-11 |
| MODIFICATION TO FOX PTA CATHETER (K020854) | Jomed AG | 2002-04-11 |
| ZOLL PAD WITH CPR AID (K011541) | Zoll Medical Corp | 2002-04-11 |
| HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB (K012956) | Hygia Health Services, Inc. | 2002-04-11 |
| VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER (K020106) | Gish Biomedical, Inc. | 2002-04-10 |
| HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER (K014025) | Hommed, LLC | 2002-04-09 |
| MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281) | Biotronik, Inc. | 2002-04-09 |
| ASTRONOMER PLUS SYSTEM (K013349) | Ep Technologies, Inc. | 2002-04-09 |
| CARDIOVENTION CORX SYSTEM, MODEL FG 0001 (K012325) | Cardiovention, Inc. | 2002-04-09 |
| HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 (K012417) | Hygia Health Services, Inc. | 2002-04-08 |
| MONITORING SYSTEM,MODEL ARGUS PB-1000 (K012226) | Schiller AG | 2002-04-08 |
| NETLINK/NETSCAN (K020213) | Rozinn Electronics, Inc. | 2002-04-05 |
| HL168F (K020766) | Health & Life Co., Ltd. | 2002-04-05 |
| KING OF HEARTS EXPRESS + AF MONITOR (K020825) | Card Guard Scientific Survival , Ltd. | 2002-04-05 |
| SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X (K020998) | Terumo Cardiovascular Systems Corp. | 2002-04-04 |
| APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K020997) | Dideco S.P.A. | 2002-04-04 |
| ADVANTA SST BIFURCATED GRAFT (K020767) | Atrium Medical Corp. | 2002-04-03 |
| SAFE-STEER GUIDE WIRE SYSTEM (K011986) | Intra Luminal Therapeutics, Inc. | 2002-04-03 |
| PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB (K020669) | Oscor, Inc. | 2002-03-28 |
| THE HAMMER MODEL H100 (K012041) | Tenacore Holdings, Inc. | 2002-03-28 |
| WIZAIR DVT (K012994) | Medical Compression Systems (Dbn) , Ltd. | 2002-03-27 |
| GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E (K012520) | Cardiac Assist Devices, Inc. | 2002-03-27 |
| PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS (K020680) | Cordis Neurovascular, Inc. | 2002-03-27 |
| JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (K014303) | Jostra AG | 2002-03-26 |
| FLOWTRON UNIVERSAL, MODEL AC600 (K010744) | Huntleigh Healthcare, Inc. | 2002-03-26 |
| COSMED QUARK C12/QUARK T12 (K014262) | Cosmed Srl | 2002-03-26 |
| DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES (K020479) | Datex-Ohmeda | 2002-03-26 |
| ZOLL PAD (K011388) | Zoll Medical Corp | 2002-03-25 |
| PVS 1500 SDS (K020733) | Precision Vascular Systems, Inc. | 2002-03-21 |
| DINAMAP PRO 1000 MONITOR, MODEL 1000 (K012915) | Ge Medical Systems Information Technologies | 2002-03-21 |
| DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 (K012989) | Dolphin Medical, Inc. | 2002-03-20 |
| CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU (K020316) | Cordis Corp. | 2002-03-20 |
| PATIENTNET MONITORING SYSTEM (K020524) | General Electric Medical Systems Information Techn | 2002-03-20 |
| PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B (K020531) | Philips Medical Systems | 2002-03-20 |
| HEARTTRENDS (K012825) | Lev-El, Ltd. | 2002-03-19 |
| ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 (K010253) | Transonic Systems, Inc. | 2002-03-19 |
| ENGUARD REMOTE PATIENT MONITOR (K020632) | Mennen Medical , Ltd. | 2002-03-15 |
| CHASE CARDIOVASCULAR PATCH KIT (K020233) | Chase Medical, Inc. | 2002-03-14 |
| AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 (K012796) | Amluck, Inc. | 2002-03-14 |
| ACIST 4 FRENCH ANGIOGRAPHIC CATHETER (K012983) | Acist Medical Systems, Inc. | 2002-03-13 |
| IN-TIME RETRIEVAL DEVICE (K014109) | Boston Scientific, Target | 2002-03-12 |
| EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K014052) | Edwards Lifesciences, LLC | 2002-03-08 |
| EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL (K014054) | Edwards Lifesciences, LLC | 2002-03-08 |
| OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) (K012891) | Nellcor Puritan Bennett, Inc. | 2002-03-07 |
| BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 (K014075) | Baylis Medical Co., Inc. | 2002-03-07 |
| XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL (K013473) | Xtrak Medical, Inc. | 2002-03-06 |
| PRIME ECG SYSTEM (K012414) | Meridian Medical Technologies, Inc. | 2002-03-06 |
| ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 (K014204) | K-Jump Health Co., Ltd. | 2002-03-05 |
| MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING (K020340) | Guidant Corp. | 2002-03-01 |
| MODEL 9210 DELIVERY CATHETER, MODEL 9210 (K013963) | Medtronic Vascular | 2002-02-28 |
| INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS (K013651) | Intervascular | 2002-02-27 |
| PADPRO, MODEL 2603 (K020288) | Padpro, LLC | 2002-02-27 |
| D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR (K020351) | Dideco S.P.A. | 2002-02-26 |
| CHASE CARDIOVASCULAR PATCH KIT (K020132) | Chase Medical, Inc. | 2002-02-26 |
| AGILTRAC .018 PERIPHERAL DILATATION CATHETER (K020161) | Guidant Corp. | 2002-02-22 |
| SPHYGMOCOR PX MODEL SCOR-PX (K012487) | Atcor Medical Pty, Ltd. | 2002-02-21 |
| MODIFICATION TO DATACAPTOR (K020197) | Capsule Technologie | 2002-02-21 |
| MODIFICATION TO M2376A DEVICELINK SYSTEM (K020494) | Philips Medical Systems, Inc. | 2002-02-21 |
| MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE (K020018) | Cardiopulmonary Corp. | 2002-02-21 |
| BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM (K013862) | Bci, Inc. | 2002-02-21 |
| SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER (K020277) | Siemens Medical Solutions USA, Inc. | 2002-02-19 |
| SIEMENS INFINITY SC 6002XL MODIFICATIONS (K020144) | Siemens Medical Solutions USA, Inc. | 2002-02-15 |
| VCS-A SERIES CLAMP (K011863) | Vascular Control Systems, Inc. | 2002-02-15 |
| A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS (K012472) | A&D Engineering, Inc. | 2002-02-15 |
| SMARTFLOW PULSE TRANSMISSION COEFFICIENT (K020127) | Florence Medical , Ltd. | 2002-02-14 |
| FLOWGUARD DEVICE (K013803) | Biosonix , Ltd. | 2002-02-13 |