Atlas FDA

Cardiovascular

19,134 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE (K905548)Mallinckrodt Medical1991-02-25
SOFTWARE PROGRAM USED W/PRISM PRODUCTS (K904978)Prism Imaging, Inc.1991-02-25
MODEL 4222 AMBULATORY ECG MONITOR (K904250)Byrncrest Global, Inc.1991-02-25
QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE (K904582)Meadox Surgimed, Inc.1991-02-25
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR (K910237)Medtronic Vascular1991-02-25
CINE'VIEW - STRESS ECHO & IMAGE REVIEW (K904976)Prism Imaging, Inc.1991-02-25
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR (K910112)Telectronics Pacing Systems, Inc.1991-02-25
INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT (K902628)Biometric Research Institute, Inc.1991-02-25
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977)Prism Imaging, Inc.1991-02-25
LP-60 LOW PRESSURE INFLATION DEVICE (K910205)Devices For Vascular Intervention, Inc.1991-02-25
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER (K905139)Cathlab Corp.1991-02-25
SARNS TEMPERATURE PROBE AND CONNECTOR (K905686)3M Health Care, Sarns1991-02-25
EMBOLECTOMY CATHETER (K902327)Clincal Instruments Corp.1991-02-25
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR (K902288)Physio-Control Corp.1991-02-25
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER (K900677)Cook, Inc.1991-02-22
CVIS INSIGHT IMAGING CATHETER (K905625)Cardiovascular Imaging Systems, Inc.1991-02-21
INTHERM TEMPORARY OCCLUSION CATHETER (K901287)Interventional Therapeutics Corp.1991-02-20
TORQUE HANDLE DEVICE FOR GUIDEWIRE (K905639)Lake Region Mfg., Inc.1991-02-20
NEW USCI 7F PTCA GUIDING CATHETER (K905249)C.R. Bard, Inc.1991-02-19
SILICONE COATED GUIDEWIRES (K905581)Lake Region Mfg., Inc.1991-02-19
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE (K903771)Hewlett-Packard Co.1991-02-19
IRRIGATION CATHETER 4, 6 AND 10 FRENCH (K902256)Applied Vascular Devices, Inc.1991-02-15
MULTI-LUMEN CENTRAL VENOUS CATHETER SET (K904404)Arrow Intl., Inc.1991-02-15
OCHSNER 50 VASCULAR PROSTHESIS (K905270)Intervascular, Inc.1991-02-15
AVALON GENERAL PURPOSE SCANNER, PREVIEW GP (K904317)Avalon Technology Corp.1991-02-13
UST-2266U-5 CW DOPPLER TRANSDUCER (K905369)Ge Medical Systems Information Technologies1991-02-11
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER (K905499)Scimed Life Systems, Inc.1991-02-11
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH (K910155)Scimed Life Systems, Inc.1991-02-07
FLO-RESTER(R) VESSEL SIZER (K905159)Bio-Vascular, Inc.1991-02-07
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER (K905458)Baxter Healthcare Corp1991-02-07
CANMED 451 (K905729)Andover Medical, Inc.1991-02-07
WEP-8430A TELEMETRY CENTRAL STATION (K904696)Nihon Kohden America, Inc.1991-02-07
PALMAZ BILIARY STENT (K905720)Johnson & Johnson Interventional Systems1991-02-05
SOFTOUCH GUIDING CATHETER (K905547)Mallinckrodt Medical1991-02-05
MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE (K905446)Medtronic Andover Medical, Inc.1991-02-05
ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC (K904088)Sentinel1991-02-05
CARDIOPULMONARY BYPASS VASCULAR CATHETER (K905224)3M Health Care, Sarns1991-02-05
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP (K905502)Advanced Cardiovascular Systems, Inc.1991-02-04
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER (K905727)C.R. Bard, Inc.1991-02-01
VASCULAR RETRIEVAL FORCEPS (K902999)Cook, Inc.1991-02-01
SARNS INVENT CATHETERS (K905638)3M Health Care, Sarns1991-02-01
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 (K904491)Lifestream Int'L, Inc.1991-02-01
MODEL 5866-37M LEAD ADAPTOR KIT (K904575)Medtronic Vascular1991-02-01
DIAVENTIONAL CATHETER (K905297)Cordis Corp.1991-02-01
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM (K904690)Marquest Medical Products, Inc.1991-02-01
TRACET AG 4000 (K904512)Lectec Corp.1991-01-31
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (K910029)Spacelabs, Inc.1991-01-31
MODEL #250 DEFIB CABLE (K904466)Cardiotronics, Inc.1991-01-30
LEAD STYLET (K905674)Cardiac Pacemakers, Inc.1991-01-30
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K905773)Mallinckrodt Medical1991-01-30
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION (K905432)Datascope Corp.1991-01-30
FUKUDA DENSHI MODEL LX-3100 (K903514)Fukuda Denshi USA, Inc.1991-01-30
BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) (K905189)Baxter Healthcare Corp1991-01-30
DIAGNOSTIC ULTRASOUND VERSADOPP 1000 (K904792)Diagnostic Ultrasound Corp.1991-01-28
TOPICAL COOLING PAD, MODEL 7000 (K905568)Daily Medical Products, Inc.1991-01-23
FLEXIBLE INTRACARDIAC SUCTION DEVICE (K905008)Gish Biomedical, Inc.1991-01-23
ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER (K903136)Arzco Medical Electronics, Inc.1991-01-18
OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C (K903133)Omron Marshall Products, Inc.1991-01-18
BIFLEX(TM) ANNULOPLASTY RING (K902159)St. Jude Medical, Inc.1991-01-18
SERIES 1500 RESPONDER (K902782)Marquette Electronics, Inc.1991-01-18
COMPACT MONITOR SMK 210,211,230,231,240 (K903917)Ppg Hellige B.V.1991-01-18
FOCUS T41,T41F,T43, T43F,T44F (K904255)Elamedical1991-01-18
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE (K903186)Telectronics Pacing Systems, Inc.1991-01-18
LAB-SITE SAFETY NEEDLE (K905018)Telos Medical Corp.1991-01-16
STEALTH DILATION CATHETER SYSTEM/MODIFICATION (K904287)Target Therapeutics1991-01-16
CONDOR DIGITAL INFLATION SYRINGE (K904954)Professional Medical Services1991-01-16
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT (K902674)Datascope Corp.1991-01-16
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT (K904282)W. L. Gore & Associates, Inc.1991-01-16
IPG-II MODULE (K903700)Life Sciences Manufacturing, Inc.1991-01-16
DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS (K905312)Baxter Bentley Laboratories, Inc.1991-01-15
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS (K904777)Baxter Healthcare Corp1991-01-15
CLOSED SYSTEM FLUSH SET (K904994)Argon Medical Corp.1991-01-15
LAB-SITE (K905017)Telos Medical Corp.1991-01-15
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST (K905100)Hewlett-Packard Co.1991-01-15
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (K903344)Kontron Instruments, Inc.1991-01-15
DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. (K905311)Baxter Bentley Laboratories, Inc.1991-01-15
MODEL 556 MONITOR (K905856)Ge Medical Systems Information Technologies1991-01-11
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES (K904741)Telectronics Pacing Systems, Inc.1991-01-08
DYNAPULSE 200M (K904739)Pulse Metric, Inc.1991-01-08
LOBOW (K905250)Perinatal Systems1991-01-08
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. (K903900)Ppg Hellige B.V.1991-01-08
OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C (K903134)Omron Marshall Products, Inc.1991-01-08
BIO-IMPEDANCE ANALYZER (K904109)Xitron Technologies, Inc.1991-01-08
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE (K904941)Cardiac Control Systems, Inc.1991-01-03
MEDTRONIC MODEL 5301B TEST CABLE (K904602)Medtronic Vascular1991-01-03
IVT INTRODUCER SHEATH (K903463)Intensive Technology, Inc.1991-01-03
ACS URETHAN CORONARY GUIDING CATHETER (K904884)Advanced Cardiovascular Systems, Inc.1991-01-03
MORSE BALLOON INFLATION DEVICE (K904275)North American Instrument Corp.1991-01-03
ATHANS EKG STANDARDIZER (K903671)Advanced Medical Concepts, Inc.1991-01-03
THERATEK GROUP EXCHANGE CATHETER (K904680)Dow Corning Wright1990-12-27
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS (K905147)Hewlett-Packard Co.1990-12-27
REFLECTANCE SENSOR (RS-10) (K904039)Nellcor, Inc.1990-12-27
CENTRAL VENOUS PRESSURE MANOMETER (K904674)Medex, Inc.1990-12-27
FIRST MEDIC MODEL 510 (K896903)Spacelabs, Inc.1990-12-27
ARIES MELDICAL MODEL 2100HC HANK CRANK (K903925)Aries Medical, Inc.1990-12-21
CARDIOMATIC MODEL MSC-2001 (K904353)Medical Systems Corp.1990-12-20
VACUUM BAKE CYCLE (K904892)Medtronic Vascular1990-12-20
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF (K905101)Hewlett-Packard Co.1990-12-20
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED (K905510)Physio-Control Corp.1990-12-20
MAGNUM-20 (TM) INFLATION DEVICE (K903621)Vascumed Systems1990-12-20
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