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
14329–14352 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 18, 1986
IMPLANTABLE ELECTRODE LEAD, MODEL 030-436
K861767 · DTB
Telectronics, Inc.
Cardiovascular · 72d
Cleared Jul 18, 1986
COBE ACCESSORY INTERFACE MODULE (AIM)
K861860 · KRL
Cobe Laboratories, Inc.
Cardiovascular · 65d
Cleared Jul 18, 1986
ACUSON L382 AND L312 TRANSDUCERS
K861866 · JOP
Acuson Computed Sonography
Cardiovascular · 66d
Cleared Jul 18, 1986
CARDIOMET 4000 GAS MONITORING SYSTEMS
K862069 · DRY
Biomedical Sensors, Inc.
Cardiovascular · 49d
Cleared Jul 17, 1986
ANGIOFLOW
K854910 · DQO
Angiomed U.S., Inc.
Cardiovascular · 220d
Cleared Jul 17, 1986
DISPOSABLE STOPCOCK
K861783 · DTL
Utah Medical Products, Inc.
Cardiovascular · 70d
Cleared Jul 17, 1986
FUTUREMED ECG SYSTEM 500
K862381 · DPS
Futuremed Div. of Future Impex Corp.
Cardiovascular · 23d
Cleared Jul 17, 1986
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
K862510 · KRI
Shiley, Inc.
Cardiovascular · 16d
Cleared Jul 16, 1986
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 148d
Cleared Jul 16, 1986
ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV
K861238 · DYB
Angiomedics, Inc.
Cardiovascular · 105d
Cleared Jul 16, 1986
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · DWB
Shiley, Inc.
Cardiovascular · 72d
Cleared Jul 16, 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116 · DWB
Shiley, Inc.
Cardiovascular · 43d
Cleared Jul 15, 1986
PINNACLE MULTI-PROGRAMMABLE PACING SYS
K853771 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 309d
Cleared Jul 15, 1986
SIEMENS SIRECUST MODELS 403P,403-2P & 403N
K855096 · DPS
Analogic Corp.
Cardiovascular · 204d
Cleared Jul 15, 1986
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
K862549 · KRI
American Bentley
Cardiovascular · 12d
Cleared Jul 11, 1986
TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE
K861115 · DQX
Toray Industries (America), Inc.
Cardiovascular · 108d
Cleared Jul 11, 1986
CURITY CENTRAL VENOUS CATHETERIZATION TRAY
K861827 · DQY
The Kendal Co.
Cardiovascular · 60d
Cleared Jul 11, 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · DRO
Medtronic Vascular
Cardiovascular · 24d
Cleared Jul 11, 1986
SNAP-ON TORQUER
K862409 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 16d
Cleared Jul 10, 1986
ACS CORONARY GUIDING CATHETER
K861236 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 99d
Cleared Jul 10, 1986
CURITY VENOUS CATHETERIZATION KIT
K861828 · DQY
The Kendal Co.
Cardiovascular · 59d
Cleared Jul 10, 1986
CURITY CENTRAL VENOUS CATHETER
K861829 · DQY
The Kendal Co.
Cardiovascular · 59d
Cleared Jul 10, 1986
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD
K862257 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD
K862258 · DTB
Intermedics, Inc.
Cardiovascular · 27d