Atlas FDA

Cardiovascular

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

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RecordFirmDate
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS (K133119)Arjohuntleigh Polska SP Z.O.O.2014-02-28
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER (K132810)Boston Scientific Corp2014-02-28
OXICARE FINGERTIP PULSE OXIMETER (K133090)Delbio Incorporation2014-02-28
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133999)Cardiovascular Systems, Inc.2014-02-28
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA (K132811)Terumo Cardiovascular Systems Corporation2014-02-27
M SERIES PATIENT MONITOR (K131876)Mid-Link Consulting Co, Ltd.2014-02-27
PRESSURE CONNECTING TUBE (K131770)Shenzhen Ant Hi-Tech Industrial Co., Ltd.2014-02-26
SUREFIRE GUIDING CATHETER (K140034)Surefire Medical, Inc.2014-02-26
MODIFIED HD GUIDE CATHETER (K133177)Concentric Medical, Inc.2014-02-25
LEADLINER CS LEAD DELIVERY SYSTEM (K133501)Vascular Solutions, Inc.2014-02-25
SE-601 SERIES ELECTROCARDIOGRAPH (K131503)Edan Instruments, Inc.2014-02-25
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (K133447)Celonova Biosciences, Inc.2014-02-24
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & (K133625)Codman & Shurtleff, Inc.2014-02-24
MONITOR B40 (K133576)Ge Medical Systems China Co., Ltd.2014-02-21
OMNI PATENT MONITORS (K132229)Infinium Medical2014-02-21
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM (K132402)Nonin Medical, Inc.2014-02-21
CANTATA(R) 2.9 MICROCATHETER (K131772)Cook, Inc.2014-02-20
ADVANCED PERFUSION SYSTEM 1 (K131041)Terumo Cardiovascular Systems Corp.2014-02-20
MEDOS HILITE INFANT OXYGENATOR (K140181)Medos Medizintechnik AG2014-02-19
SARNS SOFT-FLOW AORTIC CANNULA (K132451)Terumo Cardiovascular Systems Corp.2014-02-18
A SERIES AND Q SERIES PATIENT MONITORS (K131898)Guangdong Biolight Meditech Co., Ltd.2014-02-18
MEDOS HILITE OXYGENATOR (K140177)Medos Medizintechnik AG2014-02-18
AIRSTRIP REMOTE PATIENT MONITORING (K133450)Airstrip Technologies, LP2014-02-14
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE (K134004)Cellco Partnership D/B/A Verizon Wireless2014-02-14
ANGIOJET ULTRA AVX THROMBECTOMY SET (K133629)Possis Medical, Inc.2014-02-14
REVEAL LINQ INSERTABLE CARDIAC MONITOR (K132649)Medtronic, Inc.2014-02-14
XCATH (K133296)Alseal2014-02-14
INTRODUCER SETS, MODEL ADELANTE RADIAL (K130633)Oscor, Inc.2014-02-13
PHYSIOFLOW Q-LINK (K140102)Vasocom, Inc.2014-02-12
POWERHEART G5 AED (K122758)Cardiac Science Corporation2014-02-12
15 FR. TANDEMHEART ARTERIAL CANNULA (K133293)Cardiacassist, Inc.2014-02-12
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH (K132720)Merit Medical Systems, Inc.2014-02-12
VENA PRO (K133274)Innovamed Health, LLC2014-02-12
V8 TRANSLUMINAL BAV CATHETER (K133607)Intervalve, Inc.2014-02-11
GUAVA II (K122632)Cardiocomm Solutions, Inc.2014-02-11
ARTASSIST AND VENASSIST (K131146)Aci Medical, LLC2014-02-10
ALERTWATCH: OR (K130401)Alertwatch, LLC2014-02-07
MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT (K133552)Hansen Medical2014-02-07
AIRSTRIP REMOTE PATIENT MONITORING (K133394)Airstrip Technologies, LP2014-02-06
APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH (K140036)Aptus Endosystems, Inc.2014-02-06
ALIVECOR HEART MONITOR OTC (K130921)AliveCor, Inc.2014-02-06
VDRIVE WITH V-SONO (K133396)Stereotaxis, Inc.2014-02-06
NUVANT MCT SYSTEM (K133701)Corventis, Inc.2014-02-06
CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER (K140015)Cardiosolutions, Inc.2014-02-05
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW (K130320)Covidien2014-02-04
SHOOCIN INTRODUCER KIT (K123475)Lepu Medical Technology (Beijing) Co., Ltd.2014-02-03
SARNS HIGH FLOW AORTIC ARCH CANNULA (K133151)Terumo Cardiovascular Systems Corp.2014-02-03
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) (K132807)Welch Allyn, Inc.2014-01-31
ENLIGHTN RENAL GUIDE CATHETER (K131592)St. Jude Medical, Inc.2014-01-31
SORIN FLEXTHERM (K140012)Sorin Group Deutschland GmbH2014-01-31
DIGITAL ELECTROCARDIOGRAPH (K132758)Shenzhen Biocare Bio-Medical Equipment Co., Ltd.2014-01-30
CRUX SNARE FILTER RETRIEVAL SET (K133681)Volcano Corporation2014-01-30
CARDIOCEL (K130872)Celxcel Pty, Ltd.2014-01-30
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER (K132474)Acist Medical Systems2014-01-30
TANDEMHEART FEMORAL VENOUS CANNULA SET (K133236)Cardiacassist, Inc.2014-01-29
ADVANCE CS CORONARY SINUS INFUSION CATHETER (K131204)Cook, Inc.2014-01-29
MOORLDLS-BI LASER DOPPLER BURNS IMAGER (K132163)Moor Instruments, Ltd.2014-01-29
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 (K132782)Biosense Webster, Inc.2014-01-24
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE (K132928)Medrad, Inc. / Bayer Medical Care, Inc.2014-01-23
MAC 2000 ECG ANALYSIS SYSTEM (K133622)Wipro GE Healthcare2014-01-23
ZOE FLUID STATUS MONITOR (K133301)Noninvasive Medical Technologies, Inc.2014-01-22
PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA (K132682)Atheromed, Inc.2014-01-17
OREGON SCINTIFIC (K131245)Idt Technology Limited2014-01-17
SMARTDOP XT (K131623)Koven Technology, Inc.2014-01-17
MODIFIED TREVO PROVUE RETRIEVER (K133464)Concentric Medical, Inc.2014-01-17
HEM-7311 (K133379)Omron Healthcare, Inc.2014-01-16
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES (K132528)GE Healthcare Finland Oy2014-01-16
MODIFIED TREVO PROVUE RETRIEVER (K132641)Concentric Medical, Inc.2014-01-13
MEDOS HILITE 7000 & 7000 LT OXYGENATOR (K133261)Medos Medizintechnik AG2014-01-09
V-PATCH SYSTEM (K131000)Intelesens Limited2014-01-08
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (K130843)Oscor, Inc.2014-01-08
SIREN EPCR SUITE (K131272)Medusa Medical Technologies, Inc.2014-01-03
UNBALLOON NON-OCCLUSION MODELING CATHETER (K133026)LeMaitre Vascular, Inc.2013-12-31
ARM AUTOMATIC BLOOD PRESSURE MONITOR (K130325)Shenzhen Pump Medical System Co., Ltd.2013-12-24
MOZEC - RX PTCA BALLOON DILATATION CATHETER (K131169)Meril Life Sciences Private Limited2013-12-24
BERNOULLI ENTERPRISE SOFTWARE (K130208)Cardiopulmonary Corp.2013-12-20
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 (K132026)Mindray DS USA, Inc.2013-12-20
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM (K131765)Conmed Corporation2013-12-20
PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 (K133587)St. Jude Medical Systems AB2013-12-20
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS (K133566)Boston Scientific Corp2013-12-20
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 (K133626)MicroVention, Inc.2013-12-20
VIA MICROCATHETER, VIA PLUS MICROCATHETER (K132652)Sequent Medical, Inc.2013-12-20
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM (K133569)Bard Peripheral Vascular, Inc.2013-12-20
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE (K132623)Medtronic2013-12-19
VISI MOBILE MONITIORING SYSTEM (K133586)Sotera Wireless, Inc.2013-12-18
ZOLL EPCR IOS (K131919)ZOLL Medical Corporation2013-12-17
OPTION ELITE VENA CAVA FILTER SYSTEM (K133243)Rex Medical, L.P.2013-12-17
RHYTHM VIEW WORKSTATION (K133305)Topera, Inc.2013-12-16
REMOVABLE PATIENT LEADS ECG CABLE (K132253)Boston Scientific2013-12-16
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES (K132240)Grandway Technology (Shenzhen) Limited2013-12-16
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (K130439)Chongqing Psk Sci-Tech Development Co., Ltd.2013-12-12
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES (K133074)Datascope Corp.2013-12-12
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK (K132803)Medapps Inc., Dba Alere Connect2013-12-12
INQWIRE DIAGNOSTIC GUIDE WIRE (K133230)Merit Medical Systems, Inc.2013-12-12
CPR RSQ ASSIST (K123248)Avantech, Inc.2013-12-10
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE (K133029)Compression Works, LLC2013-12-06
HEART SYNC (K131550)Heart Sync, Inc.2013-12-06
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE (K133043)Angioslide, Ltd.2013-12-06
MCKESSON CARDIOLOGY HEMO (K131497)Mckesson Israel , Ltd.2013-12-05
BM3/BM3 PLUS (K132033)Noblitt & Rueland2013-12-04
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