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
1225–1248 of 18,110
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 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