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
673–696 of 18,110
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 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