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
1393–1416 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 03, 2022
Atrial Fibrillation History Feature
K213971 · QDB
Apple, Inc.
Cardiovascular · 165d
Cleared Jun 03, 2022
eCareManager 4.5
K211046 · MSX
Visicu, Inc.
Cardiovascular · 421d
Cleared Jun 02, 2022
Boss Crossing Support Catheter
K220632 · DQY
Marvao Medical Devices, Ltd.
Cardiovascular · 90d
Cleared Jun 02, 2022
Q Patch
K210758 · MWJ
Medicalgorithmics S.A.
Cardiovascular · 444d
Cleared Jun 01, 2022
BeneVision Central Monitoring System
K220058 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 146d
Cleared May 31, 2022
Liverty™ TIPS Access Set
K221440 · DYB
Bard Peripheral Vascular, Inc.
Cardiovascular · 14d
Cleared May 31, 2022
eMurmur Heart AI
K220766 · DQD
Csd Labs GmbH
Cardiovascular · 76d
Cleared May 31, 2022
Upper Arm Electronic Blood Pressure Monitor(Model...
K220113 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 137d
Cleared May 27, 2022
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
K212268 · DQX
FMD Co., Ltd.
Cardiovascular · 311d
Cleared May 26, 2022
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital...
K211779 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 351d
Cleared May 25, 2022
KardiaMobile 6L
K220350 · DXH
AliveCor, Inc.
Cardiovascular · 107d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · OWQ
Innovative Health, LLC
Cardiovascular · 447d
Cleared May 23, 2022
Smart Wireless Stethoscope
K220470 · DQD
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 94d
Cleared May 23, 2022
Triever24, Triever20
K213402 · QEW
Inari Medical
Cardiovascular · 217d
Cleared May 23, 2022
ONO Retrieval Device
K212988 · MMX
Onocor Vascular, LLC
Cardiovascular · 245d
Cleared May 20, 2022
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
K213540 · DWF
Qura S.R.L
Cardiovascular · 193d
Cleared May 18, 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood...
K212416 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 288d
Cleared May 17, 2022
Medline Integrated Arterial Catheter
K210548 · DQX
Centurion Medical Products
Cardiovascular · 446d
Cleared May 09, 2022
VersaCross Connect Transseptal Dilator
K220414 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 84d
Cleared May 06, 2022
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia...
K220110 · DTR
Qura S.R.L
Cardiovascular · 113d
Cleared May 06, 2022
Quantum Heater-Cooler
K212657 · DWC
Spectrum Medical , Ltd.
Cardiovascular · 256d
Cleared May 05, 2022
Viatrac 14 Plus Peripheral Dilatation Catheter
K221057 · LIT
Abbott Vascular
Cardiovascular · 24d
Cleared May 05, 2022
AcQGuide® VUE Steerable Sheath
K221044 · DRA
Acutus Medical, Inc.
Cardiovascular · 27d
Cleared May 05, 2022
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
K220691 · DQY
Seigla Medical, Inc.
Cardiovascular · 57d