FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
4105–4128 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 17, 2013
ZOLL EPCR IOS
K131919 · DXJ
ZOLL Medical Corporation
Cardiovascular · 174d
Cleared Dec 16, 2013
RHYTHM VIEW WORKSTATION
K133305 · DQK
Topera, Inc.
Cardiovascular · 49d
Cleared Dec 16, 2013
REMOVABLE PATIENT LEADS ECG CABLE
K132253 · DSA
Boston Scientific
Cardiovascular · 150d
Cleared Dec 16, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
K132240 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 151d
Cleared Dec 12, 2013
INQWIRE DIAGNOSTIC GUIDE WIRE
K133230 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 52d
Cleared Dec 12, 2013
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS...
K133074 · DSP
Datascope Corp.
Cardiovascular · 73d
Cleared Dec 12, 2013
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
K132803 · DRG
Medapps Inc., Dba Alere Connect
Cardiovascular · 97d
Cleared Dec 12, 2013
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
K130439 · DRN
Chongqing Psk Sci-Tech Development...
Cardiovascular · 294d
Cleared Dec 10, 2013
CPR RSQ ASSIST
K123248 · LIX
Avantech, Inc.
Cardiovascular · 419d
Cleared Dec 06, 2013
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K133043 · LIT
Angioslide, Ltd.
Cardiovascular · 71d
Cleared Dec 06, 2013
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
K133029 · DXC
Compression Works, LLC
Cardiovascular · 71d
Cleared Dec 06, 2013
HEART SYNC
K131550 · MKJ
Heart Sync, Inc.
Cardiovascular · 191d
Cleared Dec 05, 2013
MCKESSON CARDIOLOGY HEMO
K131497 · MWI
Mckesson Israel , Ltd.
Cardiovascular · 195d
Cleared Dec 04, 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K132604 · MWI
Covidien
Cardiovascular · 106d
Cleared Dec 04, 2013
CARESCAPE MONITOR B450
K132533 · MHX
GE Healthcare Finland Oy
Cardiovascular · 114d
Cleared Dec 04, 2013
MARS HOLTER ANALYSIS WORKSTATION
K132437 · DQK
Ge Medical Systems Information...
Cardiovascular · 121d
Cleared Dec 04, 2013
S HEALTH
K132148 · DRG
Samsung Electronics Co., Ltd.
Cardiovascular · 146d
Cleared Dec 04, 2013
BM3/BM3 PLUS
K132033 · MWI
Noblitt & Rueland
Cardiovascular · 156d
Cleared Dec 03, 2013
SURVEYOR CENTRAL STATION
K131929 · MHX
Mortara Instrument, Inc.
Cardiovascular · 159d
Cleared Nov 27, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K133282 · KRD
Reverse Medical Corporation
Cardiovascular · 33d
Cleared Nov 26, 2013
ASPIRE RX-LP6 ASPIRATION CATHETER
K131998 · QEZ
Control Medical Technology, LLC
Cardiovascular · 151d
Cleared Nov 26, 2013
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS...
K131913 · DRG
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 153d
Cleared Nov 26, 2013
CV3000 HOLTER ANALYSIS SYSTEM
K131897 · MLO
Vales & Hills Biomedical Tech. , Ltd.
Cardiovascular · 154d
Cleared Nov 26, 2013
EMOTION ECG MOBILE
K131699 · DXH
Mega Electronics , Ltd.
Cardiovascular · 168d