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
12217–12240 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 29, 1991
INTERSPEC APOGEE, MODIFICATION
K910049 · DPW
Interspec, Inc.
Cardiovascular · 112d
Cleared Apr 26, 1991
ARRHYTHMIA 9215
K900366 · DSI
S & W Medico Teknik
Cardiovascular · 455d
Cleared Apr 26, 1991
INTIMAX THROMBECTOMY CATHETER
K910372 · DXE
Applied Vascular Devices, Inc.
Cardiovascular · 87d
Cleared Apr 26, 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490 · DSI
Hewlett-Packard Co.
Cardiovascular · 80d
Cleared Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · DQO
Baxter Healthcare Corp
Cardiovascular · 98d
Cleared Apr 24, 1991
NOVOSTE GUIDING CATHETER
K911527 · DQY
Novoste Corp.
Cardiovascular · 20d
Cleared Apr 22, 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · DTB
Intermedics, Inc.
Cardiovascular · 238d
Cleared Apr 22, 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · DXK
Hewlett-Packard Co.
Cardiovascular · 181d
Cleared Apr 22, 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291 · DSI
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Apr 22, 1991
PRESSURE MONITORING EXTENSION LINE
K910378 · DQO
Professional Medical Services
Cardiovascular · 83d
Cleared Apr 22, 1991
RESTING EKG ELECTRODE SERIES
K910494 · DRX
Medtronic Andover Medical, Inc.
Cardiovascular · 76d
Cleared Apr 22, 1991
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER
K910764 · DRS
North American Instrument Corp.
Cardiovascular · 81d
Cleared Apr 22, 1991
SURGICAL TROCAR
K911462 · DRC
Applied Medical
Cardiovascular · 19d
Cleared Apr 19, 1991
ULTRA-SELECT PTCA GUIDEWIRE
K910280 · DQX
Microvena Corp.
Cardiovascular · 86d
Cleared Apr 18, 1991
URESIL VALVE CUTTER
K905528 · DWQ
Uresil Corp.
Cardiovascular · 129d
Cleared Apr 18, 1991
SCHNEIDER MAGNARAIL PROBING CATHETER
K910259 · DQO
Schneider Intl., Ltd.
Cardiovascular · 86d
Cleared Apr 18, 1991
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630 · DTD
Medtronic Vascular
Cardiovascular · 64d
Cleared Apr 18, 1991
MODEL 5857-3M LEAD END CAP KIT
K911048 · DTD
Medtronic Vascular
Cardiovascular · 41d
Cleared Apr 12, 1991
CVIS INSIGHT IMAGING CATHETER
K904618 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 183d
Cleared Apr 12, 1991
ADVANCE 418(TM)
K904984 · LIT
Peripheral Systems Group
Cardiovascular · 161d
Cleared Apr 12, 1991
DEFIBRILLATOR LEAD ADAPTER
K905065 · LDD
Spacelabs, Inc.
Cardiovascular · 156d
Cleared Apr 12, 1991
CARDIOLAB AMPLIFIER MODULE (CAM)
K910307 · DRR
Prucka Engineering, Inc.
Cardiovascular · 78d
Cleared Apr 12, 1991
PROPAQ 102, 104 AND 106
K910772 · DXN
Protocol Systems, Inc.
Cardiovascular · 49d
Cleared Apr 10, 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
K910107 · DTZ
Baxter Healthcare Corp
Cardiovascular · 90d