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
17041–17064 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 28, 1980
ENDOCARD. PACING LEAD LONG LENGTH PL200
K800349 · DTB
Diag Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ENDOCARD. PACING LEAD STD. LENGTH PL202
K800350 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE, PERM. & TEMP.
K800351 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE
K800352 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ADAPTER KIT
K800353 · DTD
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
LEAD, SUTURELESS MYOCARDIAL
K800355 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PERMANENT LEAD INTRADUCER
K800356 · DYB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACE-PULSE/COMPUTRAC
K800782 · KRE
Bib, Inc.
Cardiovascular · 50d
Cleared May 28, 1980
RESTERILIZATION OF IMPLANTABLE ELECTRODE
K800891 · DTB
Telectronics, Inc.
Cardiovascular · 40d
Cleared May 28, 1980
LARGE SCREEN CRT DISPLAY #1311B
K801000 · DXJ
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared May 28, 1980
AMBULATORY MONITOR AM-1
K801001 · DSH
Burdick Corp.
Cardiovascular · 33d
Cleared May 28, 1980
ANGIO-FLO MONITORING KIT
K801173 · KRA
Hospital Products Co.
Cardiovascular · 12d
Cleared May 23, 1980
R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.
K800930 · DRX
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122
K800931 · DSA
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120
K800932 · DSA
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)
K800935 · DRX
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171
K800936 · LDD
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 PLATE TYPE CABLE-ADAPTOR #S 175,176
K800937 · LDD
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
3M R.F. CURRENT SUPPRESSOR
K801041 · DSA
3M Company
Cardiovascular · 21d
Cleared May 23, 1980
USCI INTRALUMINAL GRAFT W/DACRON TIE
K801156 · DSY
C.R. Bard, Inc.
Cardiovascular · 9d
Cleared May 23, 1980
HYPERSTETHOSCOPE, MODEL Z 00
K801165 · DQD
Demonbinder Electronics
Cardiovascular · 8d
Cleared May 20, 1980
MODEL 5985 PACEMAKER PULSE GENERATOR
K800285 · DXY
Medtronic Vascular
Cardiovascular · 102d
Cleared May 20, 1980
SARNS 7000 MONITOR MODULE
K801097 · DTQ
3M Health Care, Sarns
Cardiovascular · 11d
Cleared May 20, 1980
PRESSURE MONITOR, MODEL 1131B
K801110 · DSK
American Optical Corp.
Cardiovascular · 8d