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
12649–12672 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 17, 1990
PCI MODEL 2041-PC TELEMETRY MONITOR
K901031 · DRT
Accucore, Inc.
Cardiovascular · 72d
Cleared May 15, 1990
KING OF HEARTS CDM
K896040 · DXH
Instromedix, Inc.
Cardiovascular · 211d
Cleared May 15, 1990
ESCORT-LINK (MODEL E3200)
K901591 · DXH
Medical Data Electronics
Cardiovascular · 40d
Cleared May 10, 1990
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797 · DXS
Shiley, Inc.
Cardiovascular · 79d
Cleared May 10, 1990
SOFT-WEDGE(TM) SYRINGE
K900879 · DYG
Baxter Healthcare Corp
Cardiovascular · 73d
Cleared May 09, 1990
MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.
K900551 · DRS
Matrix Medica, Inc.
Cardiovascular · 92d
Cleared May 09, 1990
UNIVERSAL DELIVERY SYSTEM CATHETER
K900657 · DQY
Microvena Corp.
Cardiovascular · 89d
Cleared May 09, 1990
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
K900815 · DTW
3M Company
Cardiovascular · 77d
Cleared May 09, 1990
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
K901332 · DTC
Biotronik, GmbH & Co.
Cardiovascular · 48d
Cleared May 09, 1990
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · DRQ
C.R. Bard, Inc.
Cardiovascular · 47d
Cleared May 09, 1990
GABRIEL MEDICAL CLS THERMAL RECORDER
K901385 · DSF
Gabriel Medical, Inc.
Cardiovascular · 44d
Cleared May 09, 1990
ANEROID SPHYGMOMANOMETER, DOCTOR TYPE
K901506 · DXQ
Yamasu Co. , Ltd.
Cardiovascular · 40d
Cleared May 07, 1990
STEEROCATH(TM)
K900765 · DRF
Ep Technologies, Inc.
Cardiovascular · 80d
Cleared May 03, 1990
HEARTSTART 3000
K896919 · MKJ
Laerdal Medical Corp.
Cardiovascular · 142d
Cleared May 03, 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · DTB
Medtronic Vascular
Cardiovascular · 63d
Cleared Apr 30, 1990
Y-ADAPTER W/THOUY BORST
K895580 · DYB
Angeion Corp.
Cardiovascular · 227d
Cleared Apr 30, 1990
QEKG ELECTROCARDIOGRAPH
K897121 · DPS
Qmed, Inc.
Cardiovascular · 125d
Cleared Apr 26, 1990
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · LYK
Trimedyne, Inc.
Cardiovascular · 225d
Cleared Apr 26, 1990
MODEL ECG100 SIMULATOR
K897029 · DPS
Dynatech/Nevada, Inc.
Cardiovascular · 129d
Cleared Apr 26, 1990
TRAMSCOPE SYSTEM
K900598 · DPS
Marquette Electronics, Inc.
Cardiovascular · 77d
Cleared Apr 26, 1990
MODIFIED MODEL 5401B TEST CABLE
K900622 · DXY
Medtronic Vascular
Cardiovascular · 77d
Cleared Apr 23, 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · DQO
C.R. Bard, Inc.
Cardiovascular · 256d
Cleared Apr 20, 1990
CAPIOX HARDSHELL VENOUS RESERVOIR
K894664 · DTN
Terumo Medical Corp.
Cardiovascular · 270d
Cleared Apr 20, 1990
SIMON NITINOL FILTER
K894703 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 270d