Atlas FDA

Cardiovascular

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

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RecordFirmDate
ARTERIAL EMBOLECTOMY CATHETER (K900311)Impra, Inc.1990-07-17
CARDISUNY 501AB (K901947)Graham-Field, Inc.1990-07-17
FOCUS J81F, J83F, J41F, J43F PACING LEADS (K896742)Ela Medical, Inc.1990-07-17
CARDISUNY 501BIII (K901948)Graham-Field, Inc.1990-07-17
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T (K902147)Pacesetter Systems1990-07-17
TRANS-PACE 100 (K900220)Synchromed Corp.1990-07-17
MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER (K900460)Novoste Corp.1990-07-17
FUKUDA DENSHI MODEL HJ-310 (K901889)Fukuda Denshi USA, Inc.1990-07-17
CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM (K900247)Colin Medical Instruments Corp.1990-07-17
TRAM PATIENT MONITOR (K900540)Marquette Electronics, Inc.1990-07-17
SMALL VESSEL BALLOON DILATATION CATHETER (K897124)Boston Scientific Corp1990-07-17
MODIFIED FLOCATH PULMONARY ARTERY CATHETER (K901733)Cardio Metrics, Inc.1990-07-16
SARNS DELPHIN BASE ADAPTER WITH BATTERY (K902198)3M Company1990-07-13
CARDIOMATIC MODEL MSC-1001 (K902608)Medical Systems Corp.1990-07-13
LIFE-TEL CELLULAR TRANSCEIVER (K900541)Racom, Inc.1990-07-13
CVIS INSIGHT IMAGING CATHETER (K901562)Cardiovascular Imaging Systems, Inc.1990-07-09
APPLIED VASCULAR DEVICES 6MM TRACTION CLIP (K901628)Applied Vascular Devices, Inc.1990-07-06
HOLLOW MOTOR DRIVE UNIT (K901601)Devices For Vascular Intervention, Inc.1990-07-06
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA (K901074)Dlp, Inc.1990-07-06
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE (K901691)Cardiovascular Imaging Systems, Inc.1990-07-06
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR (K902493)Datex Division Instrumentarium Corp.1990-07-06
MODIFIED EPICARDIAL ARRAY (K902228)C.R. Bard, Inc.1990-07-06
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER (K901625)Baxter Healthcare Corp1990-07-06
CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S (K902492)Datex Division Instrumentarium Corp.1990-07-06
CARDIAC OUTPUT COMPUTER, MODEL COM-3 (K896930)Baxter Healthcare Corp1990-07-03
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512 (K900246)Ppg Industries, Inc.1990-07-03
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. (K901535)Medtronic Vascular1990-07-03
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (K901624)Shiley, Inc.1990-07-03
MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY (K901815)Pioneering Technologies, Inc.1990-07-03
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS (K901682)Pioneering Technologies, Inc.1990-07-03
MINIX, MINIX ST, NEW IC: L74 (K902134)Medtronic Vascular1990-07-03
BIOPSY FORCEPS (K901300)Portlyn Corp.1990-06-29
CUFF, BLOOD PRESSURE (K902132)Buffalo Medical Specialties Mfg., Inc.1990-06-29
PACEMAKER PATIENT ADAPTOR MODULE (PPAM) (K900213)Bomed Medical Mfg., Ltd.1990-06-28
BIO-MEDICUS BIO CONSOLE MODELS 540 A B C (K901584)Bio Medicus, Inc.1990-06-28
SCIMED CORONARY GUIDING CATHETER (K895437)Scimed Life Systems, Inc.1990-06-28
MODIFIED IVT PERIPHERAL ATHERECTOMY (K901767)Intensive Technology, Inc.1990-06-28
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM (K900319)Siemens Medical Electronics1990-06-28
NAMIC PTCA Y-ADAPTOR (K900652)North American Instrument Corp.1990-06-26
DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER (K901391)Datascope Corp.1990-06-26
MONITOR, MODEL 2817 (K902334)Esaote Biomedica Spa1990-06-26
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS (K900512)Pacesetter Systems1990-06-25
PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER (K900317)Elecath1990-06-22
GRI LASERGRAPH(TM) ECG PAPER (K902586)Gri Medical Products, Inc.1990-06-22
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC. (K896964)Medtronic Vascular1990-06-21
DATASCOPE SLIDEWIRE(TM) (K901347)Datascope Corp.1990-06-21
PULSE OXIMETRY MODULE (K901071)Marquette Electronics, Inc.1990-06-19
COLORADO COLOR IMAGING RECORDER (K902230)Honeywell, Inc.1990-06-19
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 (K901402)Telectronics Pacing Systems, Inc.1990-06-12
POWERBASE II (PB2) (K901399)Nellcor, Inc.1990-06-12
SORBA MODEL CIC-1000 W/NEW ELECTRODES (K901926)Sorba Medical Systems, Inc.1990-06-12
C.P.R. LANDMARC (K900415)Can-Am Medical, Inc.1990-06-12
7620 REMOTE CENTRAL STATION REPEATER (K901884)Marquette Electronics, Inc.1990-06-12
ACS ADVANCED CONCEPT GUIDE WIRE (K900386)Advanced Cardiovascular Systems, Inc.1990-06-12
ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE (K901565)Applied Vascular Devices, Inc.1990-06-12
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (K901250)Shiley, Inc.1990-06-11
ESCORT MODEL 300 (K902060)Medical Data Electronics1990-06-11
INSITE STEERABLE GUIDEWIRE (K901224)Lake Region Mfg., Inc.1990-06-11
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (K901249)Shiley, Inc.1990-06-11
DYNATRON 330 BODY COMPOSITION ANALYZER (K900321)Dynatronics Laser Corp.1990-06-11
RMI CARDIOPLEGIA DELIVERY KITS (K901231)Research Medical, Inc.1990-06-08
HORIZON SURGICAL LIGATING AND MARKING CLIP (K901303)Horizon Surgical, Inc.1990-06-05
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS (K901018)Boston Scientific Corp1990-05-30
SIEMENS SIRECUST 732, PATIENT MONITOR (K901771)Siemens Medical Electronics1990-05-30
FLEXMEDICS GUIDEWIRE .012 ONLY (K895899)Flexmedics1990-05-23
MODEL 9101 RECORDER/ANALYZER SYSTEM (K901251)Aequitron Medical, Inc.1990-05-22
USCI(R) ACCESS(TM) INTRODUCER SET (K901452)C.R. Bard, Inc.1990-05-22
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD (K901709)Biotronik, GmbH & Co.1990-05-22
HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL (K901774)Mennen Medical, Inc.1990-05-22
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (K900910)Cobe Laboratories, Inc.1990-05-22
ANGIO-MAX (K900034)Accumed Systems, Inc.1990-05-22
CAV SAT OXIMETER MODEL 100 (K892217)Somanetics Corp.1990-05-18
MODEL 215M PATIENT SIMULATOR (K897074)Dynatech/Nevada, Inc.1990-05-17
PCI MODEL 2041-B TELEMETRY MONITOR (K896775)Accucore, Inc.1990-05-17
PCI MODEL 2041-PC TELEMETRY MONITOR (K901031)Accucore, Inc.1990-05-17
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER (K900758)Cobe Laboratories, Inc.1990-05-17
EXTRACORPOREAL HEAT EXCHANGER HE SERIES (K896020)Gish Biomedical, Inc.1990-05-17
VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA (K896338)Voss Medical Products1990-05-17
EDENTEC MODEL 2000W SYSTEM 700 MONITOR (K901060)Edentec Corp.1990-05-15
ESCORT-LINK (MODEL E3200) (K901591)Medical Data Electronics1990-05-15
KING OF HEARTS CDM (K896040)Instromedix, Inc.1990-05-15
SOFT-WEDGE(TM) SYRINGE (K900879)Baxter Healthcare Corp1990-05-10
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (K900797)Shiley, Inc.1990-05-10
MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. (K900551)Matrix Medica, Inc.1990-05-09
GABRIEL MEDICAL CLS THERMAL RECORDER (K901385)Gabriel Medical, Inc.1990-05-09
ANEROID SPHYGMOMANOMETER, DOCTOR TYPE (K901506)Yamasu Co. , Ltd.1990-05-09
UNIVERSAL DELIVERY SYSTEM CATHETER (K900657)Microvena Corp.1990-05-09
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (K901332)Biotronik, GmbH & Co.1990-05-09
BARD BIOPOTENTIAL AMPLIFIER II (K901358)C.R. Bard, Inc.1990-05-09
OXYTRAK(TM) PULSE OXIMETER (K894100)Critikon Company, LLC1990-05-09
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (K900815)3M Company1990-05-09
STEEROCATH(TM) (K900765)Ep Technologies, Inc.1990-05-07
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 (K900984)Medtronic Vascular1990-05-03
HEARTSTART 3000 (K896919)Laerdal Medical Corp.1990-05-03
QEKG ELECTROCARDIOGRAPH (K897121)Qmed, Inc.1990-04-30
MODEL 90489 PULSE OXIMETER MODULE (K901209)Spacelabs, Inc.1990-04-30
VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE (K901612)Pace Tech, Inc.1990-04-30
Y-ADAPTER W/THOUY BORST (K895580)Angeion Corp.1990-04-30
TRAMSCOPE SYSTEM (K900598)Marquette Electronics, Inc.1990-04-26
MODIFIED MODEL 5401B TEST CABLE (K900622)Medtronic Vascular1990-04-26
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