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
1537–1560 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 03, 2021
Current Health Monitoring System Gen 2 (G2)
K210133 · MSX
Current Health
Cardiovascular · 227d
Cleared Sep 03, 2021
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry...
K201305 · CAC
Atrium Medical Corporation
Cardiovascular · 476d
Cleared Sep 02, 2021
MultiCath, AcQRate Dx Fixed Curve Catheter
K201445 · DRF
Biotronik, Inc.
Cardiovascular · 458d
Cleared Aug 31, 2021
Ablamap Software
K203084 · DQK
Ablacon, Inc.
Cardiovascular · 322d
Cleared Aug 30, 2021
Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor,...
K211041 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 144d
Cleared Aug 27, 2021
AcQMap High Resolution Imaging and Mapping System
K212345 · DQK
Acutus Medical, Inc.
Cardiovascular · 30d
Cleared Aug 27, 2021
WOLF Thrombectomy System, 6F
K210530 · QEW
Devoro Medical, Inc.
Cardiovascular · 184d
Cleared Aug 26, 2021
ViperCross Support Catheters
K211240 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 122d
Cleared Aug 24, 2021
TurboHawk Plus Directional Atherectomy System
K212027 · MCW
Medtronic, Inc.
Cardiovascular · 56d
Cleared Aug 23, 2021
RenovoCath
K212324 · MJN
Renovorx, Inc.
Cardiovascular · 28d
Cleared Aug 16, 2021
Multi-Link X2 ECG Cable and Leadwire System
K211294 · DSA
Vyaire Medical, Inc.
Cardiovascular · 110d
Cleared Aug 16, 2021
iMap 3D Mapping & Navigation System (iMap System)
K201094 · DQK
Cardionxt, Inc.
Cardiovascular · 479d
Cleared Aug 13, 2021
WATCHMAN FXD Curve Access System
K212228 · DQY
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Aug 13, 2021
Jot Dx Insertable Cardiac Monitor
K212206 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 29d
Cleared Aug 13, 2021
Caretaker Platform, VitalStream Platform, CT5
K211588 · DXN
Caretaker Medical
Cardiovascular · 81d
Cleared Aug 13, 2021
Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103,...
K210671 · DXN
Weony (Shenzhen) Technology Co., Ltd.
Cardiovascular · 161d
Cleared Aug 12, 2021
Crosser iQ CTO Recanalization System
K203363 · PDU
C.R. Bard, Inc.
Cardiovascular · 269d
Cleared Aug 05, 2021
AcQMap High Resolution Imaging and Mapping System
K210680 · DQK
Acutus Medical, Inc.
Cardiovascular · 150d
Cleared Aug 03, 2021
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
K201246 · LIT
Qualimed USA, LLC
Cardiovascular · 452d
Cleared Aug 02, 2021
Bullfrog Micro-Infusion Device
K210339 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 178d
Cleared Jul 30, 2021
Pounce Thrombectomy System
K211492 · QEW
Surmodics,Inc.
Cardiovascular · 78d
Cleared Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 137d
Cleared Jul 30, 2021
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
K203224 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 270d
Cleared Jul 29, 2021
Hemafuse System
K210862 · CAC
Sisu Global Health
Cardiovascular · 128d