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
15793–15816 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 03, 1983
TRANSDUCER DOME SD105
K833095 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 03, 1983
TRANSDUCER DOME DS106
K833096 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 02, 1983
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307 · DSP
Datascope Corp.
Cardiovascular · 194d
Cleared Nov 02, 1983
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
K831397 · DSP
Datascope Corp.
Cardiovascular · 187d
Cleared Oct 31, 1983
PATIENT MONITOR #RM-100
K831817 · DRT
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
CENTRAL STATION MONITOR CSM-100
K831818 · DRT
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
MEDICAL ELECTRONICS-PRINTER CLOCK
K832012 · DSF
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
LME PATIENT MONITOR SMS 151
K832013 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
MULTISCRIPTOR EK #403 VARIOUS MODEL
K832014 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
MULTISCRIPTOR EK VARIOUS #43
K832015 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
LME BLOOD PRESSURE MONITOR
K832017 · DSK
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
SERVOMED COMPACT MONITOR 181/10105002
K832018 · DRT
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
MULTISCRIPTOR EK 36/101 047 02,05
K832130 · DPS
Litton Medical Electronics
Cardiovascular · 122d
Cleared Oct 31, 1983
SIMPLISCRIPTOR EK 31/101 037 16
K832184 · DPS
Litton Medical Electronics
Cardiovascular · 117d
Cleared Oct 31, 1983
VENOUS RESERVOIR
K832924 · DTN
Shiley, Inc.
Cardiovascular · 63d
Cleared Oct 28, 1983
CRITIKON CARDIAC OUTPUT COMPUTER
K831967 · DXG
Critikon Company, LLC
Cardiovascular · 130d
Cleared Oct 28, 1983
SILICONE RUBBER ISOLATION SLEEVE 350-01
K833199 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared Oct 27, 1983
WLECTROCARDIOGRAPH ECG-7204
K831274 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 191d
Cleared Oct 27, 1983
PACEMAKER PROGRAMMER #2032
K831859 · DXY
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
GENERATOR, PULSE, PACEMAKER #532
K831860 · DXY
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
SILICONE RUBBER ISOLATION SLEEVE 351-01
K833198 · DXY
Intermedics, Inc.
Cardiovascular · 38d
Cleared Oct 26, 1983
LME HEART-RATE MONITOR
K832016 · DRT
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT - VARIOUS
K832024 · DRT
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/
K832026 · DRT
Litton Medical Electronics
Cardiovascular · 125d