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
1297–1320 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 07, 2022
InBody Blood pressure monitor, Model BPBIO480KV
K221764 · DXN
Inbody Co., Ltd.
Cardiovascular · 112d
Cleared Oct 07, 2022
Pre-Formed Blue
K221575 · DQX
Lake Region Medical
Cardiovascular · 128d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666 · DQO
Pfm Medical, Inc.
Cardiovascular · 318d
Cleared Oct 06, 2022
A&D Medical UM-212BLE Blood Pressure Monitor
K212168 · DXN
A&D Company, Ltd.
Cardiovascular · 451d
Cleared Oct 04, 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · QEW
Penumbra, Inc.
Cardiovascular · 210d
Cleared Oct 03, 2022
Electronic Sphygmomanometer (Model: LT-P30)
K220220 · DXN
Zhuhai Linte Medical Instrument Co.,...
Cardiovascular · 250d
Cleared Sep 30, 2022
Blood Pressure Monitor(Model:Y30001)
K213023 · DXN
Zhangzhou Easepal Medical Science and...
Cardiovascular · 374d
Cleared Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
K221397 · DRA
Abbott Medical
Cardiovascular · 138d
Cleared CT Sep 28, 2022
Neteera 130H/131H Vital Sign Monitoring Sensor
K212143 · DRT
Neteera Technologies , Ltd.
Cardiovascular · 446d
Cleared Sep 26, 2022
QT ECG
K220795 · DXH
QT Medical, Inc.
Cardiovascular · 192d
Cleared Sep 26, 2022
Auryon Atherectomy Catheters
K220116 · MCW
Eximo Medical, Ltd.
Cardiovascular · 255d
Cleared Sep 23, 2022
OptiCross™ 18 Peripheral Imaging Catheter
K222568 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 23, 2022
HotDog Temperature Management System
K220941 · DWJ
Augustine Temperature Management
Cardiovascular · 176d
Cleared Sep 21, 2022
EpiFaith CV
K212615 · DQX
Flat Medical Co., Ltd.
Cardiovascular · 399d
Cleared Sep 19, 2022
LANDMARK REBOA Catheter
K214060 · MJN
Zien Medical Technologies, Inc.
Cardiovascular · 266d
Cleared Sep 14, 2022
GEM Biover Microvascular Clamps
K221843 · DXC
Synovis Micro Companies Alliance, Inc.
Cardiovascular · 82d
Cleared Sep 14, 2022
SafeSept® Transseptal Guidewire (SS-140)
K221707 · DRC
Pressure Products Medical Device...
Cardiovascular · 93d
Cleared Sep 14, 2022
SavvyWire
K213854 · DQX
Opsens, Inc.
Cardiovascular · 278d
Cleared Sep 07, 2022
Easi-Vue embolic microspheres System
K220567 · KRD
Abk Biomedical, Inc.
Cardiovascular · 191d
Cleared Sep 06, 2022
ROTAPRO Rotational Atherectomy System
K220962 · MCW
Boston Scientific Corporation
Cardiovascular · 158d
Cleared Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
K213868 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Sep 02, 2022
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
K221414 · LIT
Silk Road Medical, Inc.
Cardiovascular · 109d
Cleared Aug 31, 2022
LimFlow ARC
K221541 · PDU
LimFlow, Inc.
Cardiovascular · 96d
Cleared Aug 31, 2022
Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
K221040 · DXN
Jiangxi Aicare Medical Technology...
Cardiovascular · 146d