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
13033–13056 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 14, 1989
NEWCHILL(TM) CARDIAC INSULATOR
K892804 · DWS
Acacia Laboratories, Inc.
Cardiovascular · 88d
Cleared Jul 14, 1989
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
K893232 · DSK
Camino Laboratories, Inc.
Cardiovascular · 77d
Cleared Jul 14, 1989
VITATRACE
K893425 · DRX
Lectec Corp.
Cardiovascular · 73d
Cleared Jul 14, 1989
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT
K893436 · DWS
Pioneering Technologies, Inc.
Cardiovascular · 72d
Cleared Jul 14, 1989
BARD PLAQUE ELECTRODE ARRAY
K893611 · DRF
Bard Electrophysiology
Cardiovascular · 65d
Cleared Jul 14, 1989
MODELS 1113 AND 1114 PACEMAKER LEADS
K893763 · DTB
Possis Medical, Inc.
Cardiovascular · 56d
Cleared Jul 14, 1989
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040 · DTB
Medtronic Vascular
Cardiovascular · 38d
Cleared Jun 22, 1989
SEER
K882818 · DSI
Marquette Electronics, Inc.
Cardiovascular · 349d
Cleared Jun 22, 1989
ACTA GENOS ELECTROCARDIOGRAPH
K884800 · DPS
Parexel Intl. Corp.
Cardiovascular · 218d
Cleared Jun 22, 1989
SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.
K885349 · DXK
Sonotek Corp.
Cardiovascular · 176d
Cleared Jun 22, 1989
PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
K890292 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 154d
Cleared Jun 22, 1989
BP-8800 BLOOD PRESSURE MONITOR
K890876 · DRT
Colin Medical Instruments Corp.
Cardiovascular · 121d
Cleared Jun 22, 1989
HORIZON CENTRAL STATION
K892066 · DRT
Mennen Medical, Inc.
Cardiovascular · 84d
Cleared Jun 20, 1989
PACEMAKER LEAD ADAPTER
K890018 · DTB
Ela Medical, Inc.
Cardiovascular · 168d
Cleared Jun 20, 1989
VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM
K890047 · LYK
Vascucare, Inc.
Cardiovascular · 166d
Cleared Jun 20, 1989
USCI GREY/BLACK GUIDE WIRE
K890505 · DQX
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794 · LDF
Daig Corp.
Cardiovascular · 123d
Cleared Jun 20, 1989
GUIDE WIRE INTRODUCER
K890807 · DQX
Datascope Corp.
Cardiovascular · 124d
Cleared Jun 20, 1989
PERIFLUX PF3
K890828 · DPW
Perimed, Inc.
Cardiovascular · 119d
Cleared Jun 20, 1989
SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9
K892005 · MKJ
Physio-Control Corp.
Cardiovascular · 84d
Cleared Jun 20, 1989
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227 · DSH
Edentec Corp.
Cardiovascular · 77d
Cleared Jun 20, 1989
INTRA AORTIC BALLOON
K893243 · DSP
Datascope Corp.
Cardiovascular · 19d
Cleared Jun 20, 1989
L30-LB- INFANT LIMB BAND
K893245 · DRX
Contour Electrodes, Inc.
Cardiovascular · 53d
Cleared Jun 20, 1989
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392 · DXG
Baxter Healthcare Corp
Cardiovascular · 50d