Atlas FDA

Cardiovascular

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (K041574)Guidant Corporation2004-07-12
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE (K033858)European Custom Manufacturing BV2004-07-12
BIOPORE BALLOON DILATION CATHETER (K041293)Bipore, Inc.2004-07-09
CMI MAGNETOCARDIOGRAPH (K033488)Cmi Cardiomag Imaging, Inc.2004-07-07
STOCKERTIR PURGE CONTROL (APC) SYSTEM (K041558)Stockert Instrumente GmbH2004-07-02
MYSHELL (K040498)Sedat S.A.2004-07-02
PERIPHERAL CUTTING BALLOON (K040155)Boston Scientific Corp2004-07-01
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (K022823)Geister Medizin Technik GmbH2004-07-01
LIFEPAK 12 DEFIBRILLATOR/MONITOR (K041459)Medtronic Emergency Response Systems, Inc.2004-07-01
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 (K032937)Stereotaxis, Inc.2004-07-01
POWERHEART AED G3A (K040438)Cardiac Science, Inc.2004-07-01
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (K041686)Arizant Healthcare, Inc.2004-06-30
H-FLOW VALVE (K034043)Elcam Medical Acal2004-06-30
TELENABLE EMS SYSTEM (K040663)Molex, Inc.2004-06-30
NC SP02 ADAPTER CABLE (K041204)Masimo Corp.2004-06-29
REMOTENURSE PATIENT MONITORING SYSTEM (K041308)Webvmc, LLC2004-06-28
SCD EXPRESS PORTABLE COMPRESSION SYSTEM (K040511)Tyco Healthcare/Kendall2004-06-28
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S (K041026)Ambu, Inc.2004-06-28
VITALHEAT (K040911)Dynatherm Medical, Inc.2004-06-22
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE (K033464)Edwards Lifesciences, LLC2004-06-22
CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 (K040700)Concentric Medical, Inc.2004-06-21
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT (K040728)AngioDynamics, Inc.2004-06-18
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS (K040830)NuMED, Inc.2004-06-18
STABIL-O-GRAPH (K041313)I.E.M. GmbH2004-06-18
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP (K040730)Vascular Solutions, Inc.2004-06-18
DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P (K033896)Defibtech, LLC2004-06-16
R-TEST EVOLUTION 3 (K040753)Novacor2004-06-10
NUMED PTS X SIZING BALLOON CATHETER (K041306)NuMED, Inc.2004-06-10
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 (K041156)Nonin Medical, Inc.2004-06-09
POISE DATAENGINE (K040969)Poise Technology Corporation2004-06-08
QUANTIX OR VESSEL STABILIZER DEVICE (K041180)Cardiosonix, Ltd.2004-06-07
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES (K041281)Datascope Corp.2004-06-07
MODIFICATION TO UNITY NETWORK ID (K040559)Ge Medical Systems Information Technologies2004-06-04
SENSILASE PAD 3000 (K040654)Optical Sensors, Inc.2004-06-04
PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS (K041235)Philips Medizin Systeme Boeblingen GmbH2004-06-04
MODIFICATION TO M2376A DEVICELINK SYSTEM (K041401)Philips Medical Systems2004-06-04
MODIFICATION TO AVANT 9600 PULSE OXIMETER (K040589)Nonin Medical, Inc.2004-06-03
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM (K033711)Fukuda Denshi USA, Inc.2004-06-03
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR (K040458)Ge Medical Systems Information Technologies2004-06-03
COMBOMAP PRESSURE AND FLOW SYSTEM (K041134)Volcano Therapeutics, Inc.2004-06-02
MODIFICATION TO CAREMATIX WELLNESS SYSTEM (K040966)Carematix, Inc.2004-06-02
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS (K033048)Cas Medical Systems, Inc.2004-06-01
EXPORT CATHETER (K040869)Medtronic Vascular2004-06-01
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM (K040615)Advanced Vascular Dynamics2004-06-01
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES (K040395)Nihon Kohden America, Inc.2004-06-01
MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM (K040713)Thomas Medical Products, Inc.2004-06-01
MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 (K040552)Cryocor, Inc.2004-05-28
MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM (K040581)Vitel Net2004-05-27
ZARGIS ACOUSTIC CARDIOSCAN (K031517)Zargis Medical Corp.2004-05-26
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR (K040246)Fukuda Denshi USA, Inc.2004-05-26
SMARTLANK WIRELESS, MODEL 001970 (K033642)Mrl, A Welch Allyn Company2004-05-25
JMS BYPASS TUBE (K032977)Jms North America Corp.2004-05-25
TRANSXCHANGE SUPPORT CATHETER (K033540)Medtronic Vascular2004-05-25
HEARTSINE SAMARITAN PAD (K041067)Heartsine Technologies, Inc.2004-05-25
ZOLL AED PLUS (K033474)Zoll Medical Corp2004-05-21
MODEL 509M PULSE OXIMETER, MODEL 509M (K032755)Respironics Novametrix, Inc.2004-05-21
CELSIUS CONTROL SYSTEM (K033623)Innercool Therapies, Inc.2004-05-21
RINSPIRATION SYSTEM (K041291)Kerberos Proximal Solutions, Inc.2004-05-21
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR (K040829)Vascutek, Ltd.2004-05-20
A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR (K040371)A&D Engineering, Inc.2004-05-19
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT (K040013)Possis Medical, Inc.2004-05-18
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM (K031357)Possis Medical, Inc.2004-05-18
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 (K041228)Mytech Technology Co., Ltd.2004-05-17
LAKE REGION HYDROPHILIC GUIDEWIRE (K040825)Lake Region Mfg., Inc.2004-05-17
ENERTRON CPR JACK (K024215)Enertron Engineering Co.2004-05-14
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL (K033957)Draeger Medical Systems, Inc.2004-05-14
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN (K040955)Philips Medical Systems, Inc.2004-05-12
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 (K040165)St Jude Medical2004-05-12
VERICOR (K031327)Cvp Diagnostics, Inc.2004-05-12
INFINITY GAMMA (K041087)Draeger Medical Systems, Inc.2004-05-12
MODIFICATION TO INFINITY EXPLORER (K040945)Draeger Medical Systems, Inc.2004-05-12
FOX PLUS PTA CATHETER (K040954)Abbott Laboratories, Inc.2004-05-11
FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR (K032927)Sein Electronics Co., Ltd.2004-05-07
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS (K041061)Dideco S.P.A.2004-05-06
INTRA-AORTIC BALLOON (IAB) (K040801)Arrow Intl., Inc.2004-05-06
NVISION DATA MANAGEMENT SOFTWARE (K033307)Nonin Medical, Inc.2004-05-06
NUMED MULLINS X PTA CATHETER (K041093)NuMED, Inc.2004-05-06
GREENLIGHT 300 (K040410)A C Cossor & Son (Surgical) Limited2004-05-05
GORE TRI-LOBE BALLOON CATHETER (K033670)W. L. Gore & Associates, Inc.2004-05-05
HEARTSTART MRX, MODEL M3535A (K040404)Philips Medical Systems, Inc.2004-05-04
BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR (K033216)The Buzz Group, LLC2004-05-04
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315 (K040867)Boston Scientific Corp2004-04-30
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 (K032568)Med Textile, LLC2004-04-29
ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 (K040776)Boston Scientific Corp2004-04-29
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 (K040228)Medi-Stim A/S2004-04-29
PORTACLAMP (K033085)Cardio Life Research, S.A.2004-04-27
HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) (K040440)Http Hypothermia Therapy2004-04-27
CLIRPATH EXCIMER LASER CATHETER (K040067)Spectranetics Corp.2004-04-27
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 (K040632)Smiths Medical Asd, Inc.2004-04-27
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR (K040287)Edwards Lifesciences, LLC2004-04-26
MODIFICATION TO OUTBACK CATHETER (K040771)Lumend, Inc.2004-04-23
LIFEPAK 12 (K040775)Medtronic Physio-Control Corp.2004-04-23
MASIMO SET INTELLIVUE PULSE OXIMETER MODULE (K040259)Masimo Corp.2004-04-22
SONO TT ULTRASONIC FLOWCOMPUTER (K040909)Em-Tec GmbH2004-04-20
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (K040786)Neometrics, Inc.2004-04-19
AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T (K040528)Ya Horng Electronic Co., Ltd.2004-04-15
EP DEFLECTABLE CATHETERS (K033963)Ep Medsystems, Inc.2004-04-15
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT (K040415)Synovis Surgical Innovations2004-04-14
CARDIOVIT AT-102 (K031557)Schiller AG2004-04-14
TELECARE D.R. SERVER SOFTWARE SYSTEM (K033133)Healthcare Vision, Inc.2004-04-13
← Previous Next →

Track Cardiovascular automatically

Every clearance here is in the API, with alerts when new ones post.