FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
11905–11928 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 27, 1991
OLYMPUS RETRACTABLE VALVULOTOME
K911702 · MGZ
Olympus Corp.
Cardiovascular · 255d
Cleared Dec 27, 1991
ANGIOLAZ ANGIOSCOPE CATHETER
K913129 · LYK
Angiolaz, Inc.
Cardiovascular · 164d
Cleared Dec 27, 1991
XEMEX TEMPORARY PACING CATHETER A MODIFIED
K913521 · LDF
Zeon Medical Corp.
Cardiovascular · 143d
Cleared Dec 20, 1991
CARDIOVASCULAR REPAIR PATCH
K905073 · DXZ
Impra, Inc.
Cardiovascular · 406d
Cleared Dec 20, 1991
MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
K913358 · DXG
Ppg Industries, Inc.
Cardiovascular · 144d
Cleared Dec 20, 1991
CUSTOM TUBING PACKS
K913363 · DTL
Kroy Medical, Inc.
Cardiovascular · 144d
Cleared Dec 20, 1991
SOS BLOODLESS NEEDLE
K914330 · DYB
E-Z-Em, Inc.
Cardiovascular · 84d
Cleared Dec 20, 1991
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · DRC
E-Z-Em, Inc.
Cardiovascular · 58d
Cleared Dec 19, 1991
AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS
K912588 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 190d
Cleared Dec 19, 1991
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · DPS
Medtronic Vascular
Cardiovascular · 43d
Cleared Dec 18, 1991
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
K913691 · DTR
Gish Biomedical, Inc.
Cardiovascular · 121d
Cleared Dec 18, 1991
ANGIOGRAPHIC SOFT TIP CATHETER
K914199 · DQO
E-Z-Em, Inc.
Cardiovascular · 90d
Cleared Dec 18, 1991
MERIT DISPOSAL DEPOT(TM)
K914208 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Dec 18, 1991
DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE
K914422 · DQY
Devices For Vascular Intervention, Inc.
Cardiovascular · 76d
Cleared Dec 18, 1991
CORDIS BIPAL BIOPSY FORCEPS
K914567 · DWZ
Cordis Corp.
Cardiovascular · 64d
Cleared Dec 18, 1991
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863 · DQX
Cordis Corp.
Cardiovascular · 50d
Cleared Dec 16, 1991
ZOLL D-900 DEFIBRILLATOR
K913484 · LDD
Zmi Corp.
Cardiovascular · 132d
Cleared Dec 13, 1991
ONTRAC
K914138 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 88d
Cleared Dec 13, 1991
FEMORAL ARTERY PRESSURE PAD/DISK
K914149 · DXC
Disco, Inc.
Cardiovascular · 88d
Cleared Dec 12, 1991
MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
K912446 · DPW
Vasamedics, LLC
Cardiovascular · 192d
Cleared Dec 11, 1991
ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH
K912532 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 187d
Cleared Dec 10, 1991
RETRIEVAL DEVICE
K914067 · DQO
Target Therapeutics
Cardiovascular · 90d
Cleared Dec 09, 1991
ORG-8200A UNIVERSAL SIGNAL HOUSING
K912744 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 171d
Cleared Dec 09, 1991
FUKUDA DENSHI MODEL FCP-4101
K913811 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 105d