FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
5953–5976 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 01, 2009
PK-141 PATIENT CABLE
K083674 · DTC
Biotronik, Inc.
Cardiovascular · 111d
Cleared Mar 30, 2009
THE WAND MICROACCESS SAFETY INTRODUCER
K090372 · DYB
Access Scientific, Inc.
Cardiovascular · 45d
Cleared Mar 30, 2009
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL...
K083784 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Mar 30, 2009
EPTFE SLFTM SPIRAL VASCULAR GRAFT
K083169 · DSY
Tayside Flow Technologies Limited
Cardiovascular · 154d
Cleared Mar 26, 2009
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT...
K090659 · DQY
Medtronic, Inc.
Cardiovascular · 14d
Cleared Mar 26, 2009
CRITICOOL
K083662 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 106d
Cleared Mar 26, 2009
MORTARA STRESS ECHO BED
K082967 · DPS
Medical Positioning, Inc.
Cardiovascular · 171d
Cleared Mar 25, 2009
THE MEDCOMP .010 VASCULAR GUIDEWIRES
K081775 · DQX
Medcomp
Cardiovascular · 275d
Cleared Mar 24, 2009
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03,...
K090120 · DRF
Biosense Webster, Inc.
Cardiovascular · 62d
Cleared Mar 23, 2009
DEVON ACCUBP CUFF
K090664 · DXQ
Devon Medical, Inc.
Cardiovascular · 10d
Cleared Mar 23, 2009
PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
K090286 · DXC
Advanced Vascular Dynamics
Cardiovascular · 46d
Cleared Mar 23, 2009
CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
K083750 · MHX
Ge Medical Systems Information...
Cardiovascular · 96d
Cleared Mar 23, 2009
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA,...
K082439 · DXT
Shandong Weigao Medical Polymer Co.,...
Cardiovascular · 210d
Cleared Mar 20, 2009
DIAMONDBACK 360 DBX
K090521 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 22d
Cleared Mar 20, 2009
FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS...
K090509 · DQY
Abbott Vascular-Vascular Solutions
Cardiovascular · 22d
Cleared Mar 20, 2009
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR,...
K090483 · DPS
Philips Medical Systems
Cardiovascular · 23d
Cleared Mar 19, 2009
FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL...
K083697 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Mar 13, 2009
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
K090610 · DRG
Hospira, Inc.
Cardiovascular · 7d
Cleared Mar 13, 2009
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K083919 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 72d
Cleared Mar 11, 2009
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD)
K090325 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Mar 11, 2009
HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
K083738 · DQX
Abbott Vascular
Cardiovascular · 85d
Cleared Mar 11, 2009
LIFEPAK 15 MONITOR/DEFIBRILLATOR
K082937 · MKJ
Physio-Control, Inc.
Cardiovascular · 161d
Cleared Mar 10, 2009
CARDIOVIEW32 REVIEW MODULE
K083749 · LOS
Qrs Diagnostic, LLC
Cardiovascular · 83d
Cleared Mar 10, 2009
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
K083677 · DRX
Commwell , Ltd.
Cardiovascular · 89d