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
3121–3144 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 14, 2016
Flexitouch System
K153311 · PPS
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 302d
Cleared Sep 13, 2016
OptoMonitor II
K161263 · DXO
Opsens, Inc.
Cardiovascular · 131d
Cleared Sep 13, 2016
TXM Guiding Sheath
K153771 · DYB
Texasmedical Technologies, Inc.
Cardiovascular · 258d
Cleared Sep 09, 2016
TorqVue Low Profile Delivery Catheter
K162228 · DQY
Aga Medical Corporation (Wholly Owned...
Cardiovascular · 32d
Cleared Sep 09, 2016
AMC Health VitalCaregiving System
K151839 · MWI
Amc Health
Cardiovascular · 431d
Cleared Sep 03, 2016
CardioConfirm
K161465 · DQK
Mortara Instrument, Inc.
Cardiovascular · 99d
Cleared Sep 02, 2016
Edwards eSheath Introducer Set
K162184 · DYB
Edward Lifesciences
Cardiovascular · 29d
Cleared Sep 02, 2016
Arctic Sun Temperature Management System
K161602 · DWJ
Medivance, Inc.
Cardiovascular · 85d
Cleared Sep 02, 2016
Indy OTW Vascular Retriever
K160593 · MMX
Cook Incorporated
Cardiovascular · 185d
Cleared Sep 02, 2016
Nihon Kohden Vital Sign Telemeter
K153707 · MHX
Nihon Kohden Corporation
Cardiovascular · 254d
Cleared Aug 25, 2016
ASAHI Corsair Pro
K161126 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 126d
Cleared Aug 25, 2016
HQS Introducer (Model 2064-HQS)
K153494 · DYB
Alseal
Cardiovascular · 265d
Cleared Aug 25, 2016
V10
K152659 · DXN
Mediana Co., Ltd.
Cardiovascular · 343d
Cleared Aug 24, 2016
FFRct
K161772 · PJA
HeartFlow, Inc.
Cardiovascular · 57d
Cleared Aug 19, 2016
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA...
K161287 · DQO
Medtronic Vascular
Cardiovascular · 102d
Cleared Aug 19, 2016
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K161249 · LDF
Medtronic
Cardiovascular · 108d
Cleared Aug 18, 2016
Bullfrog Micro-Infusion Device
K161402 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 90d
Cleared Aug 18, 2016
Vein Clamps, Artery Clamps
K161315 · DXC
Aros Surgical Instruments Corporation
Cardiovascular · 99d
Cleared Aug 18, 2016
Reprocessed Compression Garments
K161105 · JOW
Covidien
Cardiovascular · 121d
Cleared Aug 18, 2016
S-Wire Guidewire System
K153397 · DQX
Concert Medical, LLC
Cardiovascular · 268d
Cleared Aug 15, 2016
PressureWire X Guidewire
K161171 · DXO
St. Jude Medical, Inc.
Cardiovascular · 111d
Cleared Aug 12, 2016
ECG100+, ECG200+
K160840 · DPS
Cardioline S.P.A
Cardiovascular · 137d
Cleared Aug 11, 2016
VSI StraitSet micro-introducer kit
K161336 · DRE
Vascular Solutions, Inc.
Cardiovascular · 90d
Cleared Aug 10, 2016
Rhythm View Workstation (non-streaming)
K161240 · DQK
Abbott Electrophysiology
Cardiovascular · 100d