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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10705–10728 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 27, 1995
MULTIPACE
K934785 · LDF
Electro-Catheter Corp.
Cardiovascular · 660d
Cleared Jul 27, 1995
DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
K951447 · DWZ
Portlyn Corp.
Cardiovascular · 120d
Cleared Jul 27, 1995
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
K952872 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Jul 25, 1995
CAPIOX ARTERIAL FILTER
K943917 · DTM
Terumo Medical Corp.
Cardiovascular · 348d
Cleared Jul 25, 1995
MEDTRONIC(R) GC III CORONARY GUIDING CATHETER
K950179 · DQY
Medtronics Interventional Vascular
Cardiovascular · 189d
Cleared Jul 25, 1995
MOLLRING CUTTER
K950813 · DWX
Cardio Vascular Concepts, Inc.
Cardiovascular · 153d
Cleared Jul 21, 1995
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
K951802 · DXT
Scimed Life Systems, Inc.
Cardiovascular · 93d
Cleared Jul 20, 1995
FEMOSTOP II
K944259 · DXC
Radi Medical Systems AB
Cardiovascular · 322d
Cleared Jul 20, 1995
CORDIS STEERABLE GUIDEWIRE
K952067 · DQX
Cordis Corp.
Cardiovascular · 79d
Cleared Jul 18, 1995
IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER
K946333 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 201d
Cleared Jul 17, 1995
SPECTRADOP
K925078 · JOP
Bennett and Assoc., Inc.
Cardiovascular · 1013d
Cleared Jul 14, 1995
ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
K942543 · DXN
Sankei Co., Ltd.
Cardiovascular · 445d
Cleared Jul 14, 1995
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
K944956 · LDF
The Heart Valve Div. Medtronic...
Cardiovascular · 280d
Cleared Jul 14, 1995
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K944957 · LDF
Medtronic Blood Systems, Inc.
Cardiovascular · 280d
Cleared Jul 14, 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
K944966 · LDF
Medtronic Blood Systems, Inc.
Cardiovascular · 276d
Cleared Jul 14, 1995
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM
K951605 · DSH
Spacelabs, Inc.
Cardiovascular · 98d
Cleared Jul 13, 1995
PARAMETERS MONITORES
K945099 · MHX
Ivy Biomedical Systems, Inc.
Cardiovascular · 268d
Cleared Jul 12, 1995
PELLETHANE 75D
K940039 · DXY
Medtronic Vascular
Cardiovascular · 554d
Cleared Jul 11, 1995
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
K951721 · LYK
Applied Medical Resources
Cardiovascular · 88d
Cleared Jul 10, 1995
URESIL(R) GUIDEWIRE
K945934 · DQX
Uresil Corp.
Cardiovascular · 217d
Cleared Jul 07, 1995
ECG ELECTRODE
K944260 · DRX
Msb , Ltd.
Cardiovascular · 311d
Cleared Jul 07, 1995
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479 · DRX
Graphic Controls Corp.
Cardiovascular · 241d
Cleared Jul 07, 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485 · DRX
Graphic Controls Corp.
Cardiovascular · 151d
Cleared Jul 03, 1995
PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400
K945985 · DQK
Burdick, Inc.
Cardiovascular · 207d