Atlas FDA

Cardiovascular

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

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RecordFirmDate
3304 PULSE OXIMETER (K962156)Bci Intl., Inc.1996-08-28
MEDILOG STRESSLINK (K951128)Oxford Medical, Inc.1996-08-28
CARBOMEDICS HANDLE (K962154)Carbomedics, Inc.1996-08-27
POSTERIOR ANNULOPLASTY BAND (MODEL 607) (K960356)The Heart Valve Div. Medtronic Cardiovascular Surg1996-08-27
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD (K962036)Medtronic Vascular1996-08-22
CARDIOCATH CATHETERIZATION LAB SYSTEM (K960321)Prucka Engineering, Inc.1996-08-21
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) (K962174)Intermedics, Inc.1996-08-21
PATIENT MONITOR MODEL 405P (K955546)Ivy Biomedical Systems, Inc.1996-08-16
DINAMAP SELECT MULTI-PARAMETER SYSTEM (K955113)Johnson & Johnson Medical, Inc.1996-08-15
MODEL 2188 CORONARY SINUS LEAD. (K961936)Medtronic Vascular1996-08-15
RMI HEMOCONCENTRACTOR TUBING SET (K961927)Research Medical, Inc.1996-08-13
THE AMPLATZ THROMBECTOMY DEVICE (K954205)Microvena Corp.1996-08-13
D. DEVICE II (K955742)Yousef Daneshvar1996-08-12
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 (K961869)Sorin Biomedical, Inc.1996-08-12
INPUT TUOHY-BORST LOCKING DEVICE (K960445)C.R. Bard, Inc.1996-08-12
EAGLE PATIENT MONITOR MODEL 3000/3100 (K961139)Marquette Electronics, Inc.1996-08-09
FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70 (K955525)Interventional Innovations Corp.1996-08-08
BODYTRODE (K961288)Marquette Electronics, Inc.1996-08-08
SPREADABLE SHEATH INTRODUCER SET (K960625)Neostar Medical Technologies, Inc.1996-08-08
TAPE & BANDAGE, ADHESIVE (K955270)Robert R. Stevens1996-08-08
CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS (K962362)Cordis Corp.1996-08-08
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM (K960544)Nasiff Assoc., Inc.1996-08-07
PRUITT SAFETY OCCLUSION CATHETER (K960422)Ideas For Medicine, Inc.1996-08-07
HEARTRAK XL (K960499)Universal Medical, Inc.1996-08-06
CONTROL SYRINGE (K960430)Scientific Device Manufacturer, LLC1996-08-06
SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) (K955534)International Innovations, Inc.1996-08-01
SCORE SOFTWARE (K961450)Nellcor Puritan Bennett, Inc.1996-08-01
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 (K961777)Cardio Metrics, Inc.1996-07-31
NORTHEAST MONITORING DR180 (K960925)North East Monitoring, Inc.1996-07-31
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS (K961679)Medtronic Vascular1996-07-30
HANC NETWORK (K952979)Healthtech Services Corp.1996-07-25
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS (K955828)Graphic Controls Corp.1996-07-25
SENTRY RADIOTRANSLUCENT ECG ELECTRODES (K962122)Sentry Medical Products, Inc.1996-07-24
G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE (K955815)Cmc Sense-It, Inc.1996-07-23
PACEART WRIST ELECTRODES (K960721)Paceart, Inc.1996-07-18
HEART 400 ECG TRANSMITTER (K953762)Aerotel, Ltd.1996-07-18
NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS (K961717)Naltiac Medical, Inc.1996-07-18
PULSE*SPRAY INFUSION SYSTEM (K961763)Angiodynamics, Div. E-Z-Em, Inc.1996-07-17
EIDOS 5003 HOLTER SYSTEM (K952969)New Product Development, Inc.1996-07-16
MAXIM PF MODELS 033-581/033-590 (K961118)Telectronics Pacing Systems, Inc.1996-07-15
CARDIMAX MODEL FX-2111 (K955416)Fukuda Denshi USA, Inc.1996-07-15
PATHFINDER 700 HOLTER ANALYZER (K951902)Reynolds Medical , Ltd.1996-07-15
3M RED DOT ECG LEAD WIRES A (K954900)Minnesota Mining and Mfg. Co.1996-07-15
QUICKELS QS 200 SYSTEM (K954772)Ferguson Medical1996-07-11
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER (K954163)Cardiac Evaluation Center, Inc.1996-07-11
QUICKELS QS 100 SYSTEM (K954773)Ferguson Medical1996-07-11
OMNI-TRAK PATIENT MONITORING SYSTEM (K955045)Invivo Research, Inc.1996-07-11
AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE (K961362)Aerotel, Ltd.1996-07-10
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL (K961445)Terumo Medical Corp.1996-07-09
SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM (K955743)Siemens Medical Solutions USA, Inc.1996-07-08
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 (K961857)Graham-Field, Inc.1996-07-03
SCIMED DISPATCH GOLD CORONARY CATHETER (K961294)Scimed Life Systems, Inc.1996-07-03
DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD (K960329)Contour Medical Technology, Inc.1996-07-02
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER (K955642)Nellcor Puritan Bennett, Inc.1996-07-02
A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR (K960319)A&D Engineering, Inc.1996-07-02
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER (K961358)Arrow Intl., Inc.1996-07-02
PERCUGLIDE (K960917)Scientific Device Manufacturer, LLC1996-07-02
INTROSTAT LEAD INTRODUCER (K960200)Msi, Inc.1996-07-02
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM (K942227)C.L. Mcintosh & Assoc., Inc.1996-06-28
USCI COMMANDER SERIES GUIDE WIRES (K961271)C.R. Bard, Inc.1996-06-27
MX960 REUSABLE PRESSURE TRANSDUCER (K961404)Medex, Inc.1996-06-27
DANESHVAR'S DEVICE (MODIFICATION) (K961461)Y. Daneshvar1996-06-26
0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP (K961232)Biocompatibles , Ltd.1996-06-26
HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM (K955853)Healthcare Service and Supply1996-06-25
STERILIZATION (K943657)Telectronics Pacing Systems, Inc.1996-06-24
DISPOSABLE ECG ELECTRODE (K953649)Kendall-Ltp1996-06-21
NMI VEIN GRAFT PERFUSION SET (K961181)Naltiac Medical, Inc.1996-06-21
NMI ANTEGRAD CARDIOPLEGIA CANNULA (K961180)Naltiac Medical, Inc.1996-06-21
BARD GRAFT SIZER (K961134)C.R. Bard, Inc.1996-06-19
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD (K955550)Intermedics, Inc.1996-06-19
MICRO ANASTOMOSIS CLAMP (K961100)R.S.P. Medical Management, Inc.1996-06-19
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (K960281)Intermedics, Inc.1996-06-18
HEARTPORT ENDOPULMONARY VENT (K961245)Heartport, Inc.1996-06-18
HEARTPORT ENDOSINUS CATHETER (K961270)Heartport, Inc.1996-06-18
AMBULATORY (HOLTER) RECORDING SYSTEM (K950944)Biosensor Corp.1996-06-18
OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER (K955342)Rashman Corp.1996-06-17
SYSTEM, THERMAL REGULATING 74-DWJ (K960167)Augustine Medical, Inc.1996-06-17
STRESSWRITER EXERCISE TESTING SYSTEM (K961009)Hewlett-Packard Co.1996-06-17
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 (K960934)Hewlett-Packard Co.1996-06-14
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 (K961301)Delphi Consulting Group1996-06-11
MEDI-TRACE RADIOLUCENT (K961395)Graphic Controls Corp.1996-06-07
OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER (K955059)Siemens Medical Solutions USA, Inc.1996-06-07
HEARTPORT ENDOAORTIC CLAMP (K955132)Heartport, Inc.1996-06-07
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960) (K952054)Siemens Medical Solutions USA, Inc.1996-06-07
MX703 AND MX730 CONTINUOUS FLUSH DEVICES (K961527)Medex, Inc.1996-06-06
ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 (K960676)Zoll Medical Corp1996-06-05
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) (K960614)Somanetics Corp.1996-06-05
SUCTION SAFETY DEVICE (K960937)R D Intl.1996-06-05
SAMS 8000 CARDIOPLEGIA MONITOR (K960916)3M Health Care, Sarns1996-06-04
AS/3 CARDIAC OUTPUT & SVO2 MODULE (K961063)Datex Medical Instrumentation, Inc.1996-05-31
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) (K960449)Biosensor Corp.1996-05-30
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT (K955460)Meadox Medicals, Div. Boston Scientific Corp.1996-05-30
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983)Medtronics Interventional Vascular1996-05-30
OCCLUSION BALLOON CATHETER (K960832)Interventional Therapeutics Corp.1996-05-29
SOLAR 9000 ANESTHESIA INFORMATION MONITOR (K954852)Marquette Electronics, Inc.1996-05-29
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (K960755)Medtronic Cardiac Surgery, Medtronic, Inc.1996-05-23
PRECLUDE IMA SLEEVE (K960532)W. L. Gore & Associates, Inc.1996-05-23
QUEST EXERCISE STRESS SYSTEM (K952417)Burdick, Inc.1996-05-22
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES (K960446)Medtronic Vascular1996-05-22
LRM (K960718)Lake Region Mfg., Inc.1996-05-21
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