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
15433–15456 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 29, 1984
MEDTRONIC 8437/8438
K843089 · DXY
Medtronic Vascular
Cardiovascular · 23d
Cleared Aug 28, 1984
LIFESCOPE II
K841499 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6201
K841500 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6102
K841501 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6105
K841502 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 27, 1984
FOGARTY OCCLUDER PAD
K831809 · DXC
Thomas J. Fogarty, M.D.
Cardiovascular · 448d
Cleared Aug 27, 1984
ANGIOGRAPHIC PROCEDURE TRAY
K840391 · DQX
Triad Medical Division
Cardiovascular · 210d
Cleared Aug 27, 1984
PRESSURE MONITOR
K842194 · DXS
Norton Texas Medical Products
Cardiovascular · 84d
Cleared Aug 27, 1984
SERVOCARD DEFIBRILLATOR SCP-851
K842235 · LDD
Litton Datamedix
Cardiovascular · 83d
Cleared Aug 27, 1984
SERVOCARD SCP-840
K842312 · LDD
Litton Datamedix
Cardiovascular · 76d
Cleared Aug 27, 1984
CARDIOTOMY RESERVOIR W/FILTER BCR-3500
K842620 · DTN
American Bentley
Cardiovascular · 53d
Cleared Aug 27, 1984
CARDIAC SUPPLY TRAY
K842645 · DQY
Deroyal Industries, Inc.
Cardiovascular · 48d
Cleared Aug 27, 1984
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE
K842667 · LDD
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Aug 27, 1984
BAIM CORONARY SINUS FLOW CALCULATOR
K842831 · DXG
Electro-Catheter Corp.
Cardiovascular · 38d
Cleared Aug 27, 1984
ARGYLE CUSTOM TUBING PACK
K842889 · DWF
Sherwood Medical Co.
Cardiovascular · 35d
Cleared Aug 27, 1984
KODAK T-MAT H FILM SO-118
K843148 · LWZ
Eastman Kodak Company
Cardiovascular · 17d
Cleared Aug 24, 1984
CPR LOCATOR
K833737 · LIX
Lifepoint,Inc
Cardiovascular · 304d
Cleared Aug 24, 1984
BP800, 850 1000
K841095 · DXN
Associated Mills, Inc.
Cardiovascular · 164d
Cleared Aug 24, 1984
ELECTRONIC DIGITAL BP METER HC 3001
K842486 · DXN
North American Philips Corp.
Cardiovascular · 59d
Cleared Aug 24, 1984
BP-1000
K843009 · DXN
Pollenex Associated Mills, Inc.
Cardiovascular · 23d
Cleared Aug 23, 1984
TX-2 THERMAL DILUTION CARDIAC OUTPUT
K834408 · DXG
Waters Instruments, Inc.
Cardiovascular · 253d
Cleared Aug 23, 1984
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO
K843262 · JOP
Hewlett-Packard Co.
Cardiovascular · 3d
Cleared Aug 22, 1984
NOVA 12 CARDIAC OUTPUT COMPUTER
K840009 · DXG
Nova Medical Specialties
Cardiovascular · 231d
Cleared Aug 22, 1984
DYNASCOPE SERIES
K840055 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 229d