Atlas FDA

Cardiovascular

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

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RecordFirmDate
STEALTH 360 ORBITAL PAD SYSTEM (K131092)Cardio Systems, Inc.2013-06-24
CARDIOSLEEVE (K131287)Rijuven Corp2013-06-24
LAWMAX DILATOR (K123842)Lifetech Scientific (Shenzhen) Co., Ltd.2013-06-24
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) (K124038)Bedside Clinical Systems, Inc.2013-06-21
MFM-CMS CENTRAL MONITORING SYSTEM (K120727)Edan Instruments, Inc.2013-06-21
VERRATA PRESSURE GUIDE WIRE (K131288)Volcano Corporation2013-06-21
ARROW GPSCATH BALLOON DILATATION CATHETER (K130397)Hotspur Technologies2013-06-20
AIRCAST VENAFLOW ELITE SYSTEM (K130722)Djo, LLC2013-06-20
PHYSIOLOGICAL DATA PROCESSOR (K122763)Zephyr Technology Corporation2013-06-20
TRANSTEK BLOOD PRESSURE MONITOR (K131395)Guangdong Transtek Medical Electronics Co., Ltd.2013-06-19
BASIXTOUCH (K130566)Merit Medical Systems, Inc.2013-06-19
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K130564)Health & Life Co., Ltd.2013-06-19
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM (K131193)Tactile Systems Technology, Inc.2013-06-18
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K130563)Health & Life Co., Ltd.2013-06-18
AZUR PUSHABLE 18 & 35 SYSTEM (K130577)MicroVention, Inc.2013-06-17
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 (K130414)Trireme Medical, Inc.2013-06-15
PG-800A SERIES (K131569)Shenzhen Pango Electronic Co., Ltd.2013-06-14
INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 (K130849)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013-06-14
GUIDEWIRE, PURSUER SERIES (K130104)Oscor, Inc.2013-06-13
DISPOSABLE 330PSI EXTENSION LINES (K120892)Coeur, Inc.2013-06-10
BEARING NSPVA EMBOLIZATION PARTICLES (K130259)Merit Medical Systems, Inc.2013-06-07
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K131300)Access Scientific, LLC2013-06-07
PRELUDE SHEATH INTRODUCER (K130791)Merit Medical Systems, Inc.2013-06-07
VECTOR PTA BALLOON DILATATION CATHETER (K131329)R4 Vascular, Inc.2013-06-06
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K131346)Microlife Intellectual Property GmbH2013-06-06
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR (K131103)Sorin Group Italia S.R.L.2013-06-06
HEARTSTRING III PROXIMAL SEAL SYSTEM (K130382)Boston Scientific Corporation2013-06-05
TEMPUS PRO PATIENT MONITOR (K130773)Remote Diagnostic Technologies , Ltd.2013-06-05
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE (K130290)Intel-Ge Care Innovations, LLC2013-06-04
ULTRACHECK CURVE BLOOD PRESSURE CUFFS (K122365)Statcorp Medical2013-06-04
VALVED TEARAWAY INTRODUCER GENERATION II (K124046)Medical Components, Inc.2013-06-03
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (K130338)ImpediMed Limited2013-05-31
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K130293)Cook, Inc.2013-05-31
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER (K131199)Bard Peripheral Vascular, Inc.2013-05-30
TRANSTEK BODY FAT ANALYZER (K130311)Guangdong Transtek Medical Electronics Co., Ltd.2013-05-30
740 SELECT (K130411)Cas Medical Systems, Inc.2013-05-29
ADROIT GUIDING CATHETER (K131225)Cordis Corp., A Johnson & Johnson Co.2013-05-29
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE (K131045)Cardiac Designs, LLC2013-05-29
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE (K130288)Cardiac Insight, Inc.2013-05-29
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K131121)Health & Life Co., Ltd.2013-05-29
VASOSTAT HEMOSTASIS DEVICE (K123041)Forge Medical, Inc.2013-05-29
FINGER PULSE OXIMETER (K123801)Shenzhen Kingyield Technology Co., Ltd.2013-05-28
MOBICATH BI-DIRECTIONAL GUIDING SHEATH (K130559)Great Batch Medical2013-05-24
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER (K130911)Ev3, Inc.2013-05-24
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER (K130639)Maquet Cardiopulmonary, AG2013-05-16
WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K123800)Little Doctor Electronic (Nantong)Co.,Ltd2013-05-15
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT (K130366)C.R. Bard, Inc.2013-05-15
VASCULAR CLAMPS (K123077)Hebumedical GmbH2013-05-14
ITCLAMP 50 (K123551)Innovative Trauma Care, Inc.2013-05-14
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) (K122013)Microlife Corp.2013-05-13
FINGERTIP PULSE OXIMETER (K123871)Beijing Choice Electronic Technololgy Co., Ltd.2013-05-10
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM (K130796)Covidien2013-05-09
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN (K123581)Covidien, Formerly Nellcor Puritan Bennett, Inc.2013-05-09
MEDLINE BLOOD PRESSURE TRANSDUCER (K123095)Medline Industries, Inc.2013-05-08
SLEEK OTW PTA CATHETER (K130786)C.R. Bard, Inc.2013-05-03
DIGITAL BLOOD PRESSURE MONITOR (K123600)Little Doctor Electronic (Nantong)Co.,Ltd2013-05-03
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM (K121404)Onset Medical Corporation2013-05-03
ENSITE VELOCITY SYSTEM (K130594)St Jude Medical2013-05-03
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 (K122388)Seca GmbH & Co. KG2013-05-02
DVTCARE CA5 (K130174)Ossur Americas, Inc.2013-05-02
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS (K130626)Ge Medical Systems Information Technologies, Inc.2013-05-01
WVSM (WIRLESS VITAL SIGNS MONITOR) (K130957)Athena Gtx2013-04-30
COMBAT READY CLAMP (K130482)Combat Medical Systems, LLC2013-04-29
REFLOW ASPIRATION CATHETER (K123482)Volcano Corporation2013-04-29
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING (K123990)Medtronic Vascular2013-04-26
BODYTRONIC 200 (K123921)Bauerfeind AG2013-04-26
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR (K120984)Masimo Corporation2013-04-26
BIOMODULE 3-M1 (K123658)Zephyr Technology Corporation2013-04-24
RHYTHM VIEW (K123295)Topera, Inc.2013-04-24
VASCULAR PROBE, VASCULAR PROBE ES (K130896)Synovis Life Technologies, Inc.2013-04-24
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM (K122826)Volcano Corporation2013-04-24
PASSEO-35 (K130161)Biotronik, Inc.2013-04-23
NEXFIN MODEL 2 (K122381)Edwards Lifesciences, LLC2013-04-22
XHIBIT CENTRAL STATION, MODEL 96102 (K122146)Spacelabs Healthcare2013-04-22
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK (K123539)Stayhealthy, Inc.2013-04-22
NEXXIS OR (K122167)Barco N.V.2013-04-22
RHYTHMIA MAPPING CATHETER (K122461)Rhythmia Medical, Inc.2013-04-18
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (K124049)Spectralmd, Inc.2013-04-18
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 (K123900)Philips Medical Systems2013-04-18
TRUECPR COACHING DEVICE (K123597)Physio-Control, Inc.2013-04-17
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT (K123083)Covidien2013-04-17
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER (K123621)Boston Scientific Corp2013-04-15
PERSONAL HEALTH CENTER (PHC) (K122076)Adflow Health Networks, Inc.2013-04-15
MICROSLIDER TEARAWAY INTRODUCER SET (K123430)Galt Medical Corp.2013-04-12
APTUS HELI-FX AORTIC SECUREMENT SYSTEM (K130677)Aptus Endosystems, Inc.2013-04-12
INFINITY CENTRALSTATION WITH INFINITY M300 (K130711)Draeger Medical Systems, Inc.2013-04-11
PATIENT MONITOR (K130056)Ld Technology, LLC2013-04-11
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K123700)Cas Medical Systems, Inc.2013-04-11
ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 (K122996)Xhale2013-04-10
JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM (K130637)Medrad, Inc.2013-04-10
GORE ACUSEAL VASCULAR GRAFT (K130215)W. L. Gore & Associates, Inc.2013-04-09
DEVON CIRONA 6100 DVT (K130571)Devon Medical, Inc.2013-04-09
PSA SERIES (K123916)Osypka Medical, Inc.2013-04-09
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT (K123153)Medtronic, Ireland2013-04-09
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF (K123996)Ge Medical Systems Information Technologies, Inc.2013-04-09
MERIT HYDROPHILIC GUIDE WIRE (K130588)Merit Medical Systems, Inc.2013-04-05
NMI COAXIAL MICROINTRODUCER SET (K123445)Navilyst Medical, Inc.2013-04-01
CARDIOMEM (K122272)Getemed Medizin- Und Informationstechnik AG2013-03-28
QUANTIEN MEASUREMENT SYSTEM (K123984)Radi Medical Systems AB2013-03-28
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF (K123762)Medtronic, Inc.2013-03-27
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