FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
17209–17232 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 25, 1980
DVT PREVENTION SYS. MBE 22 PRESSURE U.
K800337 · JOW
Med-Bio Engineering, Inc.
Cardiovascular · 39d
Cleared Mar 25, 1980
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
K800573 · DXY
Telectronics, Inc.
Cardiovascular · 11d
Cleared Mar 25, 1980
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.
K800603
Telectronics, Inc.
Cardiovascular · 8d
Cleared Mar 19, 1980
CARDIOPLEGIA DELIVERY SYSTEM
K800377 · DTR
3M Health Care, Sarns
Cardiovascular · 27d
Cleared Mar 19, 1980
PERCUTANEOUS INTRODUCER SET
K800462 · DRE
Medical Components, Inc.
Cardiovascular · 19d
Cleared Mar 18, 1980
VSM-1 PHYSIOLOGICAL MONITOR
K800492 · DPS
Physio-Control Corp.
Cardiovascular · 14d
Not Cleared Mar 17, 1980
CARPENTIER-EDWARDS FLEX. ANNULOPLASTY
K792441 · KRH
Edwards Laboratories
Cardiovascular · 109d
Cleared Mar 17, 1980
ARCOLITH 3021-CARDIAC PULSE GENERATOR
K800326 · DXY
Arco Medical Products Co.
Cardiovascular · 34d
Cleared Mar 12, 1980
CRITERION II PACING SYSTEM MONITORS
K800286 · DTC
Dart Medical Equipment
Cardiovascular · 33d
Cleared Mar 12, 1980
INFRASONDE D4000 ELECTRONIC B-P MONITOR
K800401 · DXN
Sphygmetrics, Inc.
Cardiovascular · 15d
Cleared Mar 12, 1980
CENTRAL VENOUS PRESSURE CATHETER
K800461 · DQO
Medical Components, Inc.
Cardiovascular · 12d
Cleared Mar 10, 1980
MICRONTA BP-1 ELECTRONIC B/P TESTER
K800225 · DXN
Tandy Corp.
Cardiovascular · 34d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3200
K800004 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
K800005 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Feb 29, 1980
NIASTAT
K800066 · DXN
Invivo Research Labs, Inc.
Cardiovascular · 49d
Cleared Feb 29, 1980
CIRCAMED I
K800214 · DSH
Circadian, Inc.
Cardiovascular · 28d
Cleared Feb 29, 1980
MODEL 412 ELECTROFLUIDIC MANOMETER
K800222 · DXW
Med-Tek Corp.
Cardiovascular · 25d
Cleared Feb 29, 1980
OUTPUT DIGITAL DISPLAY MODULE, MOD. 611
K800360 · DSK
Output, Inc.
Cardiovascular · 9d
Cleared Feb 28, 1980
USCI SAUVAGE EXS VASCULAR PROSTHESIS
K800149 · DSY
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Feb 26, 1980
ESOPHAGEAL PILL-ELECTRODE
K800201 · DRX
Arzbaecher & Co.
Cardiovascular · 27d
Cleared Feb 22, 1980
VXTRA BACK PACK EKG ELECTRODE CAT. NO.
K792436 · DRX
Vxtra Corp.
Cardiovascular · 86d
Cleared Feb 22, 1980
ABCO MERCURIAL SPHYGMOMANOMETER
K800236 · DXQ
Abco Dealers, Inc.
Cardiovascular · 17d
Cleared Feb 21, 1980
EXTRACORP.'S INTERSEPT CUS. TUBING PK.
K800178 · DWE
Extracorporeal Medical Specialities,...
Cardiovascular · 24d
Cleared Feb 13, 1980
IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-
K792373 · DXK
Ipco Corp.
Cardiovascular · 79d