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
16585–16608 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 20, 1981
PACEMAKER PROGRAMMER #2010
K811217 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 77d
Cleared Jul 20, 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
K811318 · LDF
Medtronic Vascular
Cardiovascular · 69d
Cleared Jul 20, 1981
OXIMETRIX ACCU SAT CPB
K811391 · DRY
Oximetrix, Inc.
Cardiovascular · 63d
Cleared Jul 20, 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691 · DXY
Cordis Corp.
Cardiovascular · 35d
Cleared Jul 20, 1981
CORATOMIC MODEL OVALITH-920BP
K811768 · DXY
Corptomic
Cardiovascular · 28d
Cleared Jul 20, 1981
VEIN-TRAP TM
K811910 · DWQ
Atrium Medical Corp.
Cardiovascular · 19d
Cleared Jul 20, 1981
VISITEC NEEDLE RANGE (CARDIOVASCULAR)
K811964 · DRC
Visitec Co.
Cardiovascular · 10d
Cleared Jul 16, 1981
THE BETA
K810940 · DSI
Burdick Corp.
Cardiovascular · 100d
Cleared Jul 16, 1981
BIOVISION CARDIAC STROBE
K811341 · DPS
Cardiac Imaging
Cardiovascular · 65d
Cleared Jul 16, 1981
MAXITHERM
K811743 · DWJ
Cincinnati Sub-Zero
Cardiovascular · 27d
Cleared Jul 16, 1981
CARDIOPULMUNARY RESUSCITATOR
K811909 · DRM
Michigan Instruments, Inc.
Cardiovascular · 15d
Cleared Jul 10, 1981
CASSETTE READER
K811253 · DSH
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jul 10, 1981
PAPER CHART RECORDER
K811254 · DSF
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jul 10, 1981
NOVATRACER RECORDER
K811453 · DSF
Novametrix Medical Systems, Inc.
Cardiovascular · 49d
Cleared Jul 10, 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · DXK
Diasonics, Inc.
Cardiovascular · 38d
Cleared Jul 10, 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638 · LDD
Datascope Corp.
Cardiovascular · 30d
Cleared Jul 10, 1981
TENSIOMETER
K811781 · DXN
Vivitek, Inc.
Cardiovascular · 17d
Cleared Jul 10, 1981
ARRYTHMIA PRINTER OPTION
K811792 · DSI
American Edwards Laboratories
Cardiovascular · 16d
Cleared Jul 02, 1981
ENDOCARDIAL ELECTRODE
K810928 · DTB
Vitatron Medical BV
Cardiovascular · 87d
Cleared Jul 02, 1981
RESIDENT BEDSIDE MONITOR
K811216 · DRT
Abbott Laboratories
Cardiovascular · 59d
Cleared Jul 01, 1981
MYOWIRE-ATEMPORARY CARDIAC PACING WIRE
K803086 · LDF
Craig & Craig, Inc.
Cardiovascular · 205d
Cleared Jul 01, 1981
STERILE PACKAGING
K811092 · DTE
Telectronics, Inc.
Cardiovascular · 71d
Cleared Jul 01, 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Jul 01, 1981
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL
K811539 · DTB
Cordis Corp.
Cardiovascular · 30d