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
14017–14040 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 23, 1987
CASSETTE TAPE REPLAY SYSTEM
K870554 · DSH
Research Instrumentation Associates,...
Cardiovascular · 41d
Cleared Mar 23, 1987
NEW MODEL STYLES FOR AORTIC ARCH CANNULA
K870825 · DQR
Shiley, Inc.
Cardiovascular · 20d
Cleared Mar 23, 1987
ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.
K870826 · DQR
Shiley, Inc.
Cardiovascular · 20d
Cleared Mar 23, 1987
TDK ECG ELECTRODE MEL-10
K870834 · DRX
Tdk Corp.
Cardiovascular · 20d
Cleared Mar 20, 1987
SHELF LIFE CHANGE OF STERILE DEVICES
K864090 · DRS
Utah Medical Products, Inc.
Cardiovascular · 178d
Cleared Mar 20, 1987
TARGET THERAPEUTICS TAPER GUIDE WIRE
K864316 · DQX
Target Therapeutics
Cardiovascular · 137d
Cleared Mar 20, 1987
THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM
K864318 · DXN
The Buddy Systems, Inc.
Cardiovascular · 137d
Cleared Mar 20, 1987
CARDIOVIT AT-6
K864465 · DPS
Schiller Corp.
Cardiovascular · 128d
Cleared Mar 20, 1987
CARDIAN III CR6A
K864704 · DPS
Cardiac Recorders, Ltd.
Cardiovascular · 108d
Cleared Mar 20, 1987
PM-8 HEART RATE MONITOR
K864748 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 105d
Cleared Mar 20, 1987
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
K870610 · DTB
Telectronics, Inc.
Cardiovascular · 46d
Cleared Mar 20, 1987
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
K870824 · DTB
Pacesetter Systems
Cardiovascular · 66d
Cleared Mar 18, 1987
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK
K870374 · DYB
Daig Corp.
Cardiovascular · 48d
Cleared Mar 17, 1987
BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010
K863833 · DSB
Body Watch, Inc.
Cardiovascular · 168d
Cleared Mar 17, 1987
MYA-1 AND MYT-1 MYELOGRAM TRAY
K870418
North Coast Medi-Tek
Cardiovascular · 42d
Cleared Mar 16, 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · DPS
Mennen Medical, Inc.
Cardiovascular · 96d
Cleared Mar 16, 1987
RMI VENOUS DRAINAGE CANNULA
K870109 · DWF
Research Medical, Inc.
Cardiovascular · 63d
Cleared Mar 16, 1987
ARIES TAPERED SHEATH
K870189 · DYB
Aries Medical, Inc.
Cardiovascular · 59d
Cleared Mar 16, 1987
GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA
K870507 · DWF
Research Medical, Inc.
Cardiovascular · 39d
Cleared Mar 13, 1987
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586 · DRX
S & W Medico Teknik
Cardiovascular · 112d
Cleared Mar 13, 1987
PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER
K865011 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 80d
Cleared Mar 12, 1987
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340
K864737 · DXN
Siemens Medical Solutions USA, Inc.
Cardiovascular · 98d
Cleared Mar 11, 1987
ERA-20
K853194 · DTE
Biotronik Sales, Inc.
Cardiovascular · 589d
Cleared Mar 11, 1987
TRACETS 2000/ELECTRODES
K863674 · DRX
Lectec Corp.
Cardiovascular · 173d