FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15193–15216 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 08, 1985
PERMATHANE 865 & 867 UNIPOLAR POLYURETH
K843703 · DTD
Pacesetter Systems
Cardiovascular · 109d
Cleared Jan 08, 1985
MEDTRONIC 6957J
K843707 · DTB
Medtronic Vascular
Cardiovascular · 109d
Cleared Jan 08, 1985
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Jan 07, 1985
NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS
K844391 · DXH
Ams Medical, Inc.
Cardiovascular · 55d
Cleared Jan 03, 1985
ND:YAG LASER PULMONARY OBSTRUCTION
K844458
Endo Lase, Inc.
Cardiovascular · 49d
Cleared Jan 02, 1985
HYDROGLIDE SPRING GUIDE WIRES
K841926 · DQX
Argon Medical Corp.
Cardiovascular · 237d
Cleared Jan 02, 1985
PTCA GUIDING CATHER
K844161 · DQO
Cordis Corp.
Cardiovascular · 71d
Cleared Jan 02, 1985
ELECTROCARDIOGRAPH ELECTRODE
K844335 · DRX
Meditect
Cardiovascular · 56d
Cleared Jan 02, 1985
CONTOUR ELECTRODE
K844345 · DRX
Heuristic Medical Systems, Inc.
Cardiovascular · 54d
Cleared Jan 02, 1985
TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA
K844752 · DTB
Mansfield Scientific, Inc.
Cardiovascular · 27d
Cleared Jan 02, 1985
ELECATH GALLAGHER MAPPING CATHETER
K844805 · DRF
Electro-Catheter Corp.
Cardiovascular · 22d
Cleared Dec 29, 1984
FILTER PURGE LINE EC-FPL SERIES
K833644 · DTL
Gish Biomedical, Inc.
Cardiovascular · 439d
Cleared Dec 27, 1984
CORDIS ENCOR ATRIAL LEAD
K811259 · DTB
Cordis Corp.
Cardiovascular · 1331d
Cleared Dec 27, 1984
VENOUS RESERVOIR-BMR-1500-HARD SHELL
K842373 · DTP
American Bentley
Cardiovascular · 195d
Cleared Dec 27, 1984
ECG PATIENT MONITOR
K843376 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 121d
Cleared Dec 27, 1984
MEDTRONIC 6957
K843706 · DTB
Medtronic Vascular
Cardiovascular · 97d
Cleared Dec 27, 1984
MEADOX SURGIMED A/S CATHETER SHEATH SYS
K843798 · DYB
Meadox Surgimed, Inc.
Cardiovascular · 91d
Cleared Dec 27, 1984
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
K843802 · DTW
Shiley, Inc.
Cardiovascular · 91d
Cleared Dec 27, 1984
MYOCARDIAL INSULATOR
K843983 · DTR
Norton Texas Medical Products
Cardiovascular · 77d
Cleared Dec 27, 1984
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003 · LDF
Electro-Catheter Corp.
Cardiovascular · 76d
Cleared Dec 27, 1984
CANMED 102
K844099 · DRX
Medtronic Vascular
Cardiovascular · 65d
Cleared Dec 27, 1984
CANMED 101
K844100 · DRX
Medtronic Vascular
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN
K844137 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI
K844138 · DWF
Shiley, Inc.
Cardiovascular · 65d