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
16657–16680 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 13, 1981
DISPOSABLE HOLDER FOR HANCOCK AORTIC
K811236 · DTJ
Vascor, Inc.
Cardiovascular · 9d
Cleared May 08, 1981
ELECTRODE BLOOD PRESSURE MONITOR
K810635 · DSK
Sears, Roebuck & Co.
Cardiovascular · 59d
Cleared May 08, 1981
DISPOSABLE, STERILE TRANSDUCER DOMES
K810735 · DRS
Bio-Med Corp.
Cardiovascular · 51d
Cleared May 08, 1981
DOUBLE VELOUR GRAFTS
K810845 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 42d
Cleared May 08, 1981
MANIFOLD
K811004 · DTZ
American Pharmaseal Div. Ahsc
Cardiovascular · 25d
Cleared May 06, 1981
DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
K810297 · DSP
Datascope Corp.
Cardiovascular · 90d
Cleared May 01, 1981
TRANSMITTER & RECEIVERS, TELEPHONE, ELEC
K810608 · DXH
Heart Check Systems, Inc.
Cardiovascular · 56d
Cleared May 01, 1981
THINLITH III UNIPOLAR CARDIAC PULSE GEN.
K810752 · DXY
Intermedics, Inc.
Cardiovascular · 42d
Cleared May 01, 1981
MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
K810800 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared May 01, 1981
EEG TELEPHONE RECEIVER MODEL #AFR-J
K810872 · DXH
Telediagnostic Systems, Inc.
Cardiovascular · 31d
Cleared May 01, 1981
IBM 5885 DIGITAL ECG ACQUISITION CART
K810988 · DPS
Intl. Business Machines
Cardiovascular · 18d
Cleared May 01, 1981
IBM 5880 ACQUISITION & ANALYSIS CART TEL
K810989 · LOS
Intl. Business Machines
Cardiovascular · 18d
Cleared May 01, 1981
CC-100
K811016 · DPS
Anthro-Metrics Corp.
Cardiovascular · 16d
Cleared May 01, 1981
MODEL 230-06 CYBERLITH TM I BIPOLAR IN
K811066 · DXY
Intermedics, Inc.
Cardiovascular · 14d
Cleared Apr 29, 1981
ARROW VESSEL CATHETER. KIT W/20GA INDWEL
K810962 · DQY
Arrow Intl., Inc.
Cardiovascular · 21d
Cleared Apr 23, 1981
CARDIOPULMONARY BYPASS OXYGENATOR
K810505 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 58d
Cleared Apr 23, 1981
DISPOSABLE 2-STAGE CANNULA
K810515 · DWF
Texas Medical Products, Inc.
Cardiovascular · 57d
Cleared Apr 23, 1981
DIRECT WRITING VECTORCARDIOGRAPH
K810529 · DYC
Elmed, Inc.
Cardiovascular · 56d
Cleared Apr 23, 1981
DISPOSABLE STOPCOCK
K810532 · DTZ
Texas Medical Products, Inc.
Cardiovascular · 56d
Cleared Apr 23, 1981
PACEMAKER LEAD ADAPTER
K810551 · DTD
Pacesetter Systems
Cardiovascular · 52d
Cleared Apr 23, 1981
COBE DISPOSABLE PRESSURE TRANSDUCER
K810637 · DRS
Cobe Laboratories, Inc.
Cardiovascular · 44d
Cleared Apr 23, 1981
SPECTRUM ANALYZER 8000
K810851 · DXG
Radionics Medical, Inc.
Cardiovascular · 24d
Cleared Apr 17, 1981
SHILEY S-100A (ADULT) BLOOD OXYGENATOR
K810470 · DTZ
Shiley, Inc.
Cardiovascular · 53d
Cleared Apr 17, 1981
SONTEK ANGIOGRAPHIC CATHETER
K810508 · DQO
Sontek Corp.
Cardiovascular · 52d