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
1321–1344 of 18,110
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