FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
14329–14352 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 06, 1986
SIREDOC 60 AND SIREDOC 220
K863331 · DSF
Siemens Medical Solutions USA, Inc.
Cardiovascular · 40d
Cleared Oct 01, 1986
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON
K860638 · DSP
Kontron Instruments, Inc.
Cardiovascular · 223d
Cleared Oct 01, 1986
TRACKER INFUSION CATHETER
K862117 · DQY
Target Therapeutics
Cardiovascular · 120d
Cleared Oct 01, 1986
STOCKERT-SHILEY CAPS TIMER MODULE
K862973 · DTQ
Shiley, Inc.
Cardiovascular · 56d
Cleared Sep 29, 1986
HEPARIN-COATED EXTRACORPOREAL CIRCUITS
K861641 · DTZ
American Bentley
Cardiovascular · 152d
Cleared Sep 29, 1986
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · DTN
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Sep 29, 1986
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 29, 1986
CORDIPAK CARDIAC CATHETERIZATION PACK
K863337 · DQO
Angi-Pak Corp.
Cardiovascular · 32d
Cleared Sep 29, 1986
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
K863661 · DTL
Medical Components, Inc.
Cardiovascular · 11d
Cleared Sep 26, 1986
DR-2C (MODIFICATION)
K862596 · DSF
General Devices
Cardiovascular · 91d
Cleared Sep 24, 1986
MODIFIED CARDIOCAP MONITOR
K862455 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 89d
Cleared Sep 24, 1986
BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE
K862937 · DQX
Versaflex Delivery Systems, Inc.
Cardiovascular · 51d
Cleared Sep 24, 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418 · DXY
Intermedics, Inc.
Cardiovascular · 21d
Cleared Sep 23, 1986
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 53d
Cleared Sep 23, 1986
SPACELABS SERIES 90700 PATIENT MONITORS
K862951 · DPS
Spacelabs, Inc.
Cardiovascular · 49d
Cleared Sep 23, 1986
MODIFIED PTCA GUIDING CATHETERS
K862975 · DQY
Cordis Corp.
Cardiovascular · 56d
Cleared Sep 23, 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · DXT
C.R. Bard, Inc.
Cardiovascular · 42d
Cleared Sep 23, 1986
BIOTRONIK PERMANENT PACEMAKER ELECTRODE
K863480 · DTB
Biotronik Sales, Inc.
Cardiovascular · 14d
Cleared Sep 19, 1986
MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD
K862053 · DTB
Intermedics, Inc.
Cardiovascular · 113d
Cleared Sep 19, 1986
MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD
K862054 · DTB
Intermedics, Inc.
Cardiovascular · 113d
Cleared Sep 19, 1986
ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
K862983 · DQX
Target Therapeutics
Cardiovascular · 43d
Cleared Sep 19, 1986
UMI STEERABLE TORQUE GUIDE WIRE
K863178 · DQX
Universal Medical Instrument Corp.
Cardiovascular · 32d
Cleared Sep 19, 1986
MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS
K863322 · DQY
Quinton, Inc.
Cardiovascular · 23d
Cleared Sep 17, 1986
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 34d