Atlas FDA

Cardiovascular

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

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RecordFirmDate
ABPM7100 (K140928)I.E.M. GmbH2014-09-15
INTRA. OX HANDHELD TISSUE OXIMETER (K133983)Vioptix, Inc.2014-09-12
ARTIMES BALLOON DILATATION CATHETER (K141025)Brosmed Medical2014-09-12
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE (K140608)Merit Medical Systems, Inc.2014-09-12
Direxion Torqueable Microcatheter (K142259)Boston Scientific Corp2014-09-10
SPACELABS HEALTHCARE TELEMETRY RECEIVER (K141156)Spacelabs Healthcare2014-09-09
FRIMAP ADAPTER CONNECTOR (MAC) (K142182)Topera, Inc.2014-09-09
ECARE COORDINATOR (ECC) (K141706)Visicu, Inc.2014-09-09
HD BLOOD PRESSURE MONITOR (K141924)Biocare Asia Corporation , Ltd.2014-09-08
ELI 380 ELECTROCARDIOGRAPH (K142105)Mortara Instrument, Inc.2014-09-05
HYDRAVIEW GUIDEWIRE (K141831)Brivant Limited2014-09-04
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER (K141495)Edwards Lifesciences, LLC2014-09-03
VDRIVE WITH V-LOOP/ VDRIVE DUO (K140804)Stereotaxis, Inc.2014-09-03
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF (K140874)Shanghai Goahui Rubber and Plastic Company2014-09-02
MEMO 3D ReChord (K142221)Sorin Group Italia S.R.L.2014-08-29
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (K132943)Synaptic Medical Limited2014-08-29
FINGERTIP PULSE OXIMETER (K140582)Shenzhen Jumper Medical Equipment Co., Ltd.2014-08-28
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 (K133023)Medrad, Inc.2014-08-27
CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) (K140338)Creganna-Tactx Medical2014-08-27
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP (K140944)Atheromed, Inc.2014-08-22
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR (K141083)Microlife Intellectual Property GmbH2014-08-22
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER (K140028)Galt Medical Corp.2014-08-21
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER (K141521)Boston Scientific Corporation2014-08-21
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER (K141769)Lightlab Imaging, Inc.2014-08-18
PHYSIOGLOVE ET SYSTEM (K133703)Commwell R&D , Ltd.2014-08-18
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE (K141951)Medtronic, Inc.2014-08-15
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER (K141090)Medtronic, Inc.2014-08-15
ALIVECOR HEART MONITOR (K140933)AliveCor, Inc.2014-08-15
TEMPUS PRO WITH ENHANCED FEATURES (K133973)Remote Diagnostic Technologies , Ltd.2014-08-14
FINGERTIP PULSE OXIMETER (K141128)Beijing Choice Electronic Technololgy Co., Ltd.2014-08-13
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) (K134014)Remote Diagnostic Technologies , Ltd.2014-08-12
LLD EZ (K142116)Spectranetics, Inc.2014-08-12
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES (K141209)Celonova Biosciences, Inc.2014-08-07
HI-TORQUE VERSATURN GUIDE WIRE (K141782)Abbott Vascular2014-08-07
NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K141236)Boston Scientific Corporation2014-08-07
MAGELLAN ROBOTIC SYSTEM (K141614)Hansen Medical2014-08-07
SAAD PATIENT MONITOR (SPM) (K133222)Hanin Medical Services Co., Ltd.2014-08-06
TANDEMHEART VENO-VENOUS CANNULA (K140999)Cardiacassist, Inc.2014-08-06
RHYTHMSTAR SYSTEM (K141813)RhythMedix, LLC2014-08-05
SENSEI X ROBOTIC CATHETER SYSTEM (K141822)Hanson Medical, Inc.2014-08-05
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER (K141496)Reflectance Medical, Inc.2014-08-04
TEBCO-W (K132892)Bomed, Inc.2014-08-01
PASSPORT SERIES PATIENT MONITORS (K132662)Shenzhen Mindray Biomedical Electronics Co., Ltd.2014-08-01
ZOLL X SERIES (K133484)Zoll Medical Corp2014-08-01
SYVEK RADIAL BAND (K132293)Marine Polymer Technologies2014-07-31
TRAXCESS 14 GUIDEWIRE (K133725)MicroVention, Inc.2014-07-31
OXIPROBE E (OXIPROBE) (K132516)Bio Medical Technologies Co., Ltd.2014-07-30
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) (K141167)Vitalconnect, Inc.2014-07-29
MR SYRINGE DUAL PACK (K140469)Coeur, Inc.2014-07-28
COCOON CONVECTIVE WARMING SYSTEM (K140635)Care Essentials Pty, Ltd.2014-07-25
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K133658)Terumo Cardiovascular Systems Corp.2014-07-25
BELTER BLOOD PRESSURE METER (K134029)Shenzhen Belter Health Measurement and Analysis TE2014-07-25
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (K140096)Hmicro, Inc.2014-07-24
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM (K140775)Spectranetics Corporation2014-07-23
EQUALIZER OCCLUSION BALLOON CATHETER (K140273)Boston Scientific Corp2014-07-22
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K141678)Abbott Vascular2014-07-22
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER (K134031)Boston Scientific Corporation2014-07-21
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER (K141118)Ev3, Inc.2014-07-18
FINGERTIP PULSE OXIMETER (K140682)Beijing Choice Electronic Technololgy Co., Ltd.2014-07-17
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER (K141112)Boston Scientific2014-07-16
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES (K140813)Covidien2014-07-15
CORMATRIX ECM FOR VASCULAR REPAIR (K140789)Cormatrix Cardiovascular, Inc.2014-07-15
PULSTAR LOGIX PUMP (K141609)Albahealth, LLC2014-07-15
CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (K141582)Welch Allyn2014-07-11
MERIT SAFETY INTRODUCER NEEDLE (K140513)Merit Medical Systems, Inc.2014-07-09
INTRODUCER, MODEL ADELANTE MAGNUM (K140917)Oscor, Inc.2014-07-09
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS (K141618)Arrow International, Inc (Subsidiary of Teleflex I2014-07-08
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH (K141432)Maquet Cardiopulmonary, AG2014-07-07
PULSE OXIMETER (K140785)Nonin Medical, Inc.2014-07-07
MICROPUNCTURE INTRODUCER SET (K133114)Cook Incorporated2014-07-03
EDWARDS TRANSFEMORAL BALLOON CATHETER (K140241)Edwards Lifesciences, LLC2014-07-03
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA (K140641)Boston Scientific Corporation2014-07-03
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K140572)Microlife Intellectual Property GmbH, Switzerland2014-07-02
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K140121)Andon Health Co, Ltd.2014-07-02
ARROW GPSCATH BALLOON DILATATION CATHETER (K140351)Hotspur Technologies,Inc Subsidiary of Teleflex ME2014-07-02
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER (K140129)Icu Medical, Inc.2014-07-02
SPHYGMOMANOMETER (K141392)Suzhou JJ Meter Co., Ltd.2014-07-02
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM (K133861)Ostial Corporation2014-07-02
ODISSEY TISSUE OXIMETER (K141234)Vioptix, Inc.2014-07-01
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET (K141148)Cook Vascular, Inc.2014-07-01
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 (K133916)Biosense Webster, Inc.2014-07-01
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) (K132036)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014-07-01
DUAL SHOT ALPHA 7 (K133189)Nemoto Kyorindo Co., Ltd.2014-06-30
DEVON CIRONA 6200 DVT (K141578)Devon Medical2014-06-27
A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR (K141179)A & D Co., Ltd.2014-06-27
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER (K133843)Cordis Corporation2014-06-27
SURESIGNS VS3, SURESIGNS VS4 (K133961)Philips Medical Systems2014-06-26
MASIMO ROOT MONITORING SYSTEM (K140188)Masimo Corporation2014-06-25
NOVOPRESS (K131416)Milka, LLC2014-06-23
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM (K141313)Reverse Medical Corporation2014-06-18
QARDIOARM (K140067)Qardio, Inc.2014-06-18
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES (K140583)Grandway Technology (Shenzhen) Limited2014-06-18
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM (K140312)Edwards Lifesciences, LLC2014-06-13
740 SELECT (K140430)Cas Medical Systems, Inc.2014-06-13
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE (K140695)Medtronic, Inc.2014-06-12
TRIPLEPLAY PRO (K141360)Wildcat Medical, Inc.2014-06-12
AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE (K141233)Medtronic, Inc.2014-06-12
DIGITAL ELECTROCARDIOGRAPH (K131858)Guangdong Biolight Meditech Co., Ltd.2014-06-11
CONTRAST MODULATION SYSTEM (K140425)Osprey Medical, Inc.2014-06-11
PCD 737A (K140642)Mego Afek AC , Ltd.2014-06-10
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