FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
13897–13920 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 07, 1987
SILENT GUARD CAT. NO. SG-10
K873488 · DTL
American Omni Medical, Inc.
Cardiovascular · 37d
Cleared Oct 07, 1987
PULL-APART INTRODUCER (SHEATH)
K873727 · DYB
Quinton, Inc.
Cardiovascular · 28d
Cleared Oct 06, 1987
MODEL MR-45 AMBULATORY HOLTER MONITOR
K872497 · DSI
Oxford Medilog, Inc.
Cardiovascular · 104d
Cleared Oct 02, 1987
ADULT WALKING HEEL PRODUCT NO. 4183-130
K873716 · LDF
Martin Medical
Cardiovascular · 17d
Cleared Oct 01, 1987
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM
K872517 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 99d
Cleared Sep 30, 1987
MODIFIED RADIUS - MODEL NUMBER MM 5000
K871727 · JOP
Ultrasonix, Inc.
Cardiovascular · 155d
Cleared Sep 30, 1987
CHURCHILL INTER-CARDIAC SUCKER
K872043 · DWF
Churchill Corp.
Cardiovascular · 126d
Cleared Sep 30, 1987
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
K872068 · DPW
Advanced Technology Laboratories, Inc.
Cardiovascular · 124d
Cleared Sep 30, 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 111d
Cleared Sep 30, 1987
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596 · DRS
American Edwards Laboratories
Cardiovascular · 90d
Cleared Sep 30, 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719 · DTN
Shiley, Inc.
Cardiovascular · 82d
Cleared Sep 30, 1987
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
K873206 · DTW
Respiratory Support Products, Inc.
Cardiovascular · 47d
Cleared Sep 30, 1987
OVAL PULL-APART SHEATH/DILATOR
K873394 · DYB
Quinton, Inc.
Cardiovascular · 37d
Cleared Sep 28, 1987
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
K871416 · JOP
Acuson Computed Sonography
Cardiovascular · 174d
Cleared Sep 28, 1987
ACUSON L538 TRANSDUCER
K871506 · JOP
Acuson Computed Sonography
Cardiovascular · 164d
Cleared Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · LDF
Medtronic Vascular
Cardiovascular · 415d
Cleared Sep 25, 1987
ESCORT PORTABLE PATIENT MONITOR
K872291 · DXO
Medical Data Electronics
Cardiovascular · 101d
Cleared Sep 25, 1987
MODEL MICRO FD+ AMBULATORY ECG MONITOR
K872508 · DSH
Advanced Medical Products, Inc.
Cardiovascular · 93d
Cleared Sep 25, 1987
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
K872788 · DWF
Uresil Corp.
Cardiovascular · 73d
Cleared Sep 25, 1987
VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
K873035 · DQY
Gish Biomedical, Inc.
Cardiovascular · 52d
Cleared Sep 24, 1987
VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
K871369 · LDE
Keeler Instruments, Inc.
Cardiovascular · 170d
Cleared Sep 24, 1987
TORAY ANTHRON AORTA BYPASS TUBES
K872762 · DWF
Toray Industries (America), Inc.
Cardiovascular · 73d
Cleared Sep 23, 1987
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
K872720 · DTN
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
K872721 · DTN
Shiley, Inc.
Cardiovascular · 75d