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
16969–16992 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 04, 1980
DESERET EMBOLECTOMY/THROMBECTOMY CATH.
K801650 · DXE
Deseret Medical, Inc.
Cardiovascular · 17d
Cleared Jul 28, 1980
BLADE SEPTOSTOMY CATHETER
K801031 · DXF
Cook, Inc.
Cardiovascular · 88d
Cleared Jul 28, 1980
DILATOR, VESSEL, FOR PERC. CATHETER.
K801113 · DRE
Alva Medical, Inc.
Cardiovascular · 77d
Cleared Jul 28, 1980
PRUITT VASCULAR SHUNT
K801359 · DWF
Ideas For Medicine, Inc.
Cardiovascular · 49d
Cleared Jul 28, 1980
BARO/TRAC II & VITA/TRAC, VITAL SIGN MON
K801389 · DXN
Bib, Inc.
Cardiovascular · 45d
Cleared Jul 28, 1980
MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR
K801552 · KRB
Edwards Laboratories
Cardiovascular · 20d
Cleared Jul 28, 1980
SHIELD DISPOSABLE BLOOD PRESSURE CUFF
K801568 · DXQ
American Convertors Div., American...
Cardiovascular · 20d
Cleared Jul 28, 1980
OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT
K801641 · DTS
Ohio Medical Products
Cardiovascular · 11d
Cleared Jul 21, 1980
A-V MINI CLINIC
K800405 · DRT
Instromedix, Inc.
Cardiovascular · 146d
Cleared Jul 21, 1980
ULTRA IMAGER
K800553 · DXK
Honeywell, Inc.
Cardiovascular · 132d
Cleared Jul 21, 1980
VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR
K800596 · DXN
Bib, Inc.
Cardiovascular · 126d
Cleared Jul 21, 1980
SINVISION LINEAR ARRAY REAL TIME
K800653 · DXK
Kt Medical, Inc.
Cardiovascular · 119d
Cleared Jul 21, 1980
LINEAR ARRAY SCANNER
K800805 · DXK
Philips Medical Systems (Cleveland),...
Cardiovascular · 102d
Cleared Jul 21, 1980
HIGH STOY SMALL PARTS SCANNER #SP-100B
K800850 · DXK
Highstoy
Cardiovascular · 97d
Cleared Jul 21, 1980
ADAPTAID HELICAL COIL ADAPTER 365-14
K801039 · DTD
Intermedics, Inc.
Cardiovascular · 80d
Cleared Jul 14, 1980
MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.
K801138 · DRS
Gics Pharmaceuticals
Cardiovascular · 63d
Cleared Jul 14, 1980
STERILE, DISP DOME, INDIVID. PKG.
K801239 · DRS
Pacific Domes, Inc.
Cardiovascular · 48d
Cleared Jul 14, 1980
CARDIOTOMY RESERVOIR WITH FILTER
K801360 · DTP
Travenol Laboratories, S.A.
Cardiovascular · 35d
Cleared Jul 14, 1980
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K801375 · DTP
Shiley, Inc.
Cardiovascular · 33d
Cleared Jul 14, 1980
PORTA-FIB LPD
K801544 · LDD
Narco Bio-Systems
Cardiovascular · 7d
Cleared Jul 14, 1980
MODEL R11 SINGLE CHANNEL CHART RECORDER
K801549 · DSF
Medasonics, Inc.
Cardiovascular · 7d
Cleared Jul 08, 1980
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17
K801038 · DTD
Intermedics, Inc.
Cardiovascular · 67d
Cleared Jul 08, 1980
MULTICOR (GAMMA) MODEL 336 & MODEL 337
K801106 · DXY
Cordis Corp.
Cardiovascular · 60d
Cleared Jul 08, 1980
EC-4 PLETHYSMOGRAPH
K801291 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 36d