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
13249–13272 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 10, 1989
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · LIT
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Mar 10, 1989
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · DYB
Oscor Medical Corp.
Cardiovascular · 51d
Cleared Mar 10, 1989
CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
K890504 · JOD
Gish Biomedical, Inc.
Cardiovascular · 37d
Cleared Mar 10, 1989
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 23d
Cleared Mar 09, 1989
NR2000 CARDIAC MONITOR
K883903 · DPS
Nirad , Ltd.
Cardiovascular · 175d
Cleared Mar 09, 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 136d
Cleared Mar 09, 1989
ELECTRODE GEL
K884504 · DPS
Herbert Stanley Co.
Cardiovascular · 135d
Cleared Mar 09, 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · DSF
Mennen Medical, Inc.
Cardiovascular · 106d
Cleared Mar 09, 1989
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
K884983 · DRX
S & W Medico Teknik
Cardiovascular · 100d
Cleared Mar 09, 1989
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
K884984 · DRX
S & W Medico Teknik
Cardiovascular · 100d
Cleared Mar 09, 1989
WELLSHIRE BASELINK
K890558 · DXH
American Executive Technology
Cardiovascular · 31d
Cleared Mar 06, 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 158d
Cleared Mar 03, 1989
STONY BROOK MODEL EECP-MC1
K882401 · DRN
Stony Brook Trading and Development...
Cardiovascular · 266d
Cleared Mar 03, 1989
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K885281 · KRA
Baxter Healthcare Corp
Cardiovascular · 66d
Cleared Mar 02, 1989
ASTRO TRACE (MODEL AT-01)
K884592 · DSA
The LE Blanc Corp.
Cardiovascular · 119d
Cleared Mar 02, 1989
SARNS VENT CATHETER
K890024 · DWF
3M Company
Cardiovascular · 57d
Cleared Mar 02, 1989
SMDS460 SURGICAL MONITOR DISPLAY SYSTEM
K890353 · DXJ
Vidco, Inc.
Cardiovascular · 37d
Cleared Mar 02, 1989
PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
K890492 · DXO
Endosonics Corp.
Cardiovascular · 30d
Cleared Mar 02, 1989
WELLSHIRE EMLINK MODEL 1000
K890508 · DXH
American Executive Technology
Cardiovascular · 29d
Cleared Feb 23, 1989
HIGH RESOLUTION OPTION FOR MAC SERIES ELECTROCARDI
K884087 · LOS
Marquette Electronics, Inc.
Cardiovascular · 149d
Cleared Feb 23, 1989
PATIENT MONITOR MODEL 701
K884096 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 148d
Cleared Feb 23, 1989
BP-408 MARK II
K884885 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 93d
Cleared Feb 23, 1989
BP-308 MARK II
K884896 · DPS
Colin Medical Instruments Corp.
Cardiovascular · 93d
Cleared Feb 23, 1989
Q750 ELECTROCARDIOGRAPH
K885000 · LOS
Quinton, Inc.
Cardiovascular · 84d