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
12577–12600 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 17, 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · LIT
Boston Scientific Corp
Cardiovascular · 203d
Cleared Jul 17, 1990
TRANS-PACE 100
K900220 · DTE
Synchromed Corp.
Cardiovascular · 181d
Cleared Jul 17, 1990
CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM
K900247 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 181d
Cleared Jul 17, 1990
ARTERIAL EMBOLECTOMY CATHETER
K900311 · DXE
Impra, Inc.
Cardiovascular · 176d
Cleared Jul 17, 1990
LEOCOR CORFLO(TM) PUMP
K900350 · DXK
Leocor, Inc.
Cardiovascular · 174d
Cleared Jul 17, 1990
MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER
K900460 · DQO
Novoste Corp.
Cardiovascular · 168d
Cleared Jul 17, 1990
TRAM PATIENT MONITOR
K900540 · DSI
Marquette Electronics, Inc.
Cardiovascular · 162d
Cleared Jul 17, 1990
FUKUDA DENSHI MODEL HJ-310
K901889 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 82d
Cleared Jul 17, 1990
CARDISUNY 501AB
K901947 · DPS
Graham-Field, Inc.
Cardiovascular · 78d
Cleared Jul 17, 1990
CARDISUNY 501BIII
K901948 · DPS
Graham-Field, Inc.
Cardiovascular · 78d
Cleared Jul 17, 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · DTB
Pacesetter Systems
Cardiovascular · 63d
Cleared Jul 16, 1990
MODIFIED FLOCATH PULMONARY ARTERY CATHETER
K901733 · DPW
Cardio Metrics, Inc.
Cardiovascular · 90d
Cleared Jul 13, 1990
LIFE-TEL CELLULAR TRANSCEIVER
K900541 · DXH
Racom, Inc.
Cardiovascular · 158d
Cleared Jul 13, 1990
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198 · KFM
3M Company
Cardiovascular · 58d
Cleared Jul 13, 1990
CARDIOMATIC MODEL MSC-1001
K902608 · DRT
Medical Systems Corp.
Cardiovascular · 31d
Cleared Jul 09, 1990
CVIS INSIGHT IMAGING CATHETER
K901562 · DXK
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 97d
Cleared Jul 06, 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · DWF
Dlp, Inc.
Cardiovascular · 120d
Cleared Jul 06, 1990
HOLLOW MOTOR DRIVE UNIT
K901601 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 91d
Cleared Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625 · DXE
Baxter Healthcare Corp
Cardiovascular · 88d
Cleared Jul 06, 1990
APPLIED VASCULAR DEVICES 6MM TRACTION CLIP
K901628 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 88d
Cleared Jul 06, 1990
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
K901691 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jul 06, 1990
MODIFIED EPICARDIAL ARRAY
K902228 · DRF
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Jul 06, 1990
CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S
K902492 · DRI
Datex Division Instrumentarium Corp.
Cardiovascular · 31d
Cleared Jul 06, 1990
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
K902493 · DRI
Datex Division Instrumentarium Corp.
Cardiovascular · 31d