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
12049–12072 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 18, 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235 · DTB
Intermedics, Inc.
Cardiovascular · 127d
Cleared Sep 18, 1991
LEMAITRE-BOOKWALTER VESSEL DEVICES
K912548 · DWP
Vascutech, Inc.
Cardiovascular · 100d
Cleared Sep 16, 1991
CORDIS INFLATOR DEVICE
K912644 · MAV
Cordis Corp.
Cardiovascular · 91d
Cleared Sep 13, 1991
MINIMAX OXYGENATION SYSTEM
K912655 · DTZ
Medtronic Vascular
Cardiovascular · 88d
Cleared Sep 11, 1991
CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE
K911308 · DXH
Medical Equipment Designs, Inc.
Cardiovascular · 173d
Cleared Sep 11, 1991
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599 · DRO
Physio-Control Corp.
Cardiovascular · 93d
Cleared Sep 11, 1991
MX 339 TWIN HEMOSTATIC Y CONNECTOR
K912709 · DTL
Medex, Inc.
Cardiovascular · 84d
Cleared Sep 11, 1991
OPEN ENDED GUIDEWIRE
K912878 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 72d
Cleared Sep 11, 1991
MORSE VASCULAR INTRODUCER SET
K912961 · DYB
North American Instrument Corp.
Cardiovascular · 65d
Cleared Sep 10, 1991
CASIO BP-100
K910643 · DXN
Casio, Inc.
Cardiovascular · 209d
Cleared Sep 10, 1991
MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
K912627 · MHX
Ppg Industries, Inc.
Cardiovascular · 88d
Cleared Sep 09, 1991
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · KRH
Baxter Healthcare Corp
Cardiovascular · 90d
Cleared Sep 06, 1991
ACCUCORE TELEMETRY, MODIFICATION
K905506 · DSI
S & W Medico Teknik
Cardiovascular · 281d
Cleared Sep 06, 1991
ACS RX SUPPORT CATHETER
K911957 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 127d
Cleared Sep 06, 1991
SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE
K912156 · DQX
Schneider Intl., Ltd.
Cardiovascular · 115d
Cleared Sep 06, 1991
HEART TECHNOLOGY ROTABLATOR WIRECLIP
K913450 · MCW
Heart Technology, Inc.
Cardiovascular · 35d
Cleared Sep 05, 1991
WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)
K901619 · LOS
Wex Medical Instrumentation Co.
Cardiovascular · 517d
Cleared Sep 05, 1991
CARDIOCAP II(TM)
K912530 · DXN
Datex Medical Instrumentation, Inc.
Cardiovascular · 90d
Cleared Sep 05, 1991
MEGA PERICARDIOCENTESIS KIT
K912564 · DQY
Mega Medical, Inc.
Cardiovascular · 86d
Cleared Sep 04, 1991
WARMTOUCH
K913016 · DWJ
Advanced Warming Systems, Inc.
Cardiovascular · 65d
Cleared Sep 04, 1991
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226 · DRX
Cardiotronics, Inc.
Cardiovascular · 47d
Cleared Sep 03, 1991
CPI MODEL 2215 & SEAMED MODEL 3400
K912507 · DTE
Seamed Corp.
Cardiovascular · 89d
Cleared Aug 30, 1991
SCIMED 7 FR. & 8 FR.
K913364 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 32d
Cleared Aug 29, 1991
LP-PLUS
K903774 · DPS
Fidelity Medical, Inc.
Cardiovascular · 374d