Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
1609–1632 of 18,182
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 CT 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