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
745–768 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 28, 2024
NUVISION™ Ultrasound Catheter
K241540 · OBJ
Biosense Webster, Inc.
Cardiovascular · 28d
Cleared Jun 28, 2024
Patient Monitor (RespArray)
K240320 · MHX
Edan Instruments, Inc.
Cardiovascular · 147d
Cleared Jun 28, 2024
Cordis BRITECROSS Support Catheter
K233637 · DQY
Cordis US Corp
Cardiovascular · 228d
Cleared Jun 27, 2024
Auryon Atherectomy Catheter 1.7mm
K241553 · MCW
Eximo Medical, Ltd.
Cardiovascular · 27d
Cleared Jun 27, 2024
Swan-Ganz Pacing Probe and Catheters
K233983 · DYG
Edwards Lifesciences
Cardiovascular · 192d
Cleared Jun 27, 2024
EsoCool Thermal Regulation Catheter
K233357 · PLA
Nuvaira, Inc.
Cardiovascular · 272d
Cleared CT Jun 26, 2024
ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK,...
K241507 · DTK
Aln S.A.R.L.
Cardiovascular · 29d
Cleared Jun 26, 2024
WVSM Pro (Series) (500-0030-XX)
K233354 · MWI
Athena Gtx, Inc.
Cardiovascular · 271d
Cleared Jun 25, 2024
ASAHI Veloute
K241158 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Jun 25, 2024
Venowave VW5
K232640 · JOW
Thermabright
Cardiovascular · 305d
Cleared Jun 25, 2024
NeoBeat, NeoBeat Mini
K232111 · MWI
Laerdal Medical AS
Cardiovascular · 347d
Cleared Jun 21, 2024
MINAMO blue
K240387 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 134d
Cleared Jun 21, 2024
Therm-X (Home)
K240125 · JOW
Zenith Technical Innovations
Cardiovascular · 157d
Cleared Jun 21, 2024
Nimbl (model PD08-N1)
K234155 · JOW
Tactile Medical
Cardiovascular · 175d
Cleared Jun 21, 2024
Tempus ECG-AF
K233549 · SBQ
Tempus AI, Inc.
Cardiovascular · 231d
Cleared Jun 21, 2024
Merge Hemo, Model RCSV2
K233326 · DQK
Merge Healthcare Incorporated
Cardiovascular · 266d
Cleared Jun 21, 2024
eCARTv5 Clinical Deterioration Suite (“eCART”)
K233253 · QNL
Agilemd, Inc.
Cardiovascular · 267d
Cleared Jun 20, 2024
DeepRhythm Platform
K232161 · DPS
Medicalgorithmics S.A.
Cardiovascular · 336d
Cleared Jun 17, 2024
XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
K232258 · PNO
Transit Scientific, LLC
Cardiovascular · 322d
Cleared Jun 15, 2024
Multi-parameter detector
K231116 · MNW
Zhongshan Jinli Electronic Weighing?...
Cardiovascular · 422d
Cleared Jun 14, 2024
Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39,...
K240729 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 88d
Cleared Jun 13, 2024
Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
K241370 · DYB
Abbott Medical
Cardiovascular · 30d
Cleared Jun 13, 2024
FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
K240460 · DQX
FMD Co., Ltd.
Cardiovascular · 118d
Cleared Jun 12, 2024
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541)
K241352 · DTZ
Medtronic, Inc.
Cardiovascular · 30d