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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
10321–10344 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 15, 1996
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
K963038 · DRX
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Nov 14, 1996
FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000
K952826 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 513d
Cleared Nov 14, 1996
FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000
K952827 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 513d
Cleared Nov 13, 1996
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520 · LDF
Medtronic Vascular
Cardiovascular · 205d
Cleared Nov 13, 1996
CORDIS ST STEERABLE GUIDEWIRE
K963214 · DQX
Cordis Corp.
Cardiovascular · 89d
Cleared Nov 08, 1996
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
K961582 · DTC
North American Technical Services Corp.
Cardiovascular · 198d
Cleared Nov 08, 1996
PACE-1A CARDIAC STIMULATOR
K963579 · JOQ
Radionics, Inc.
Cardiovascular · 63d
Cleared Nov 07, 1996
CATH SEAL
K962180 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 154d
Cleared Nov 07, 1996
HEARTPORT CABLE BULLDOG CLAMP
K962366 · DXC
Heartport, Inc.
Cardiovascular · 141d
Cleared Nov 07, 1996
CINCH QR SGW EXTENSION
K963171 · DQX
Cordis Corp.
Cardiovascular · 85d
Cleared Nov 06, 1996
WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
K961292 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 216d
Cleared Nov 06, 1996
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
K961797 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 181d
Cleared Nov 06, 1996
WLP SINGLE-SEGMENT VERSION WLP SOLO VII
K961891 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 181d
Cleared Nov 04, 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE...
K955122 · DTB
Intermedics, Inc.
Cardiovascular · 361d
Cleared Nov 04, 1996
LIFEPAK 500
K955854 · MKJ
Physio-Control Corp.
Cardiovascular · 312d
Cleared Nov 04, 1996
MICROFERRET CATHETER
K961668 · KRA
Cook, Inc.
Cardiovascular · 188d
Cleared Nov 04, 1996
AMR-ACV CLAMPS
K962668 · DXC
Applied Medical Resources
Cardiovascular · 118d
Cleared Nov 04, 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930...
K963187 · DSP
Boston Scientific Corp
Cardiovascular · 82d
Cleared Nov 01, 1996
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
K961272 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 213d
Cleared Nov 01, 1996
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · DTN
Medtronic Vascular
Cardiovascular · 172d
Cleared Oct 31, 1996
AUTOMATIC TUBING CLAMP SYSTEM (ATC)
K961364 · KRL
Rocky Mountain Research, Inc.
Cardiovascular · 205d
Cleared Oct 30, 1996
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
K954850 · DTZ
C.R. Bard, Inc.
Cardiovascular · 373d
Cleared Oct 30, 1996
BARD QUANTUM CVR
K962726 · DTP
C.R. Bard, Inc.
Cardiovascular · 107d
Cleared Oct 29, 1996
DEFIBRILLATOR ANALYZER, DELTA 1000
K961595 · DRL
Netech Corp.
Cardiovascular · 188d