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
1225–1248 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 29, 2022
Multi-Parameter Patient Monitor
K211619 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 582d
Cleared Dec 29, 2022
EndoPATx
K211557 · DQK
Itamar Medical , Ltd.
Cardiovascular · 589d
Cleared Dec 27, 2022
EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software...
K223094 · DQK
Abbott Medical
Cardiovascular · 88d
Cleared Dec 27, 2022
IOB Warming Blankets
K221669 · DWJ
Iob Medical, Inc.
Cardiovascular · 201d
Cleared Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · OCL
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 22, 2022
TruWave Disposable Pressure Transducer
K222216 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Dec 21, 2022
AZUR HydroPack 18 (45-880005
K223050 · KRD
MicroVention, Inc.
Cardiovascular · 83d
Cleared Dec 21, 2022
Mural Clinical Viewer
K222586 · MHX
Ge Medical Systems Information...
Cardiovascular · 117d
Cleared Dec 21, 2022
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter
K222538 · LOX
Sino Medical Sciences Technology, Inc.
Cardiovascular · 121d
Cleared Dec 21, 2022
LimFlow Vector
K221902 · MGZ
LimFlow, Inc.
Cardiovascular · 174d
Cleared Dec 20, 2022
Indigo Aspiration System - Lightning Flash
K222358 · QEW
Penumbra, Inc.
Cardiovascular · 138d
Cleared Dec 20, 2022
EK12 V2 Algorithm
K221904 · MHX
Ge Medical Systems Information...
Cardiovascular · 173d
Cleared Dec 19, 2022
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · OWQ
Abbott Medical
Cardiovascular · 147d
Cleared Dec 19, 2022
Mechanical Guidewire
K221351 · DQX
Baylis Medical Company, Inc.
Cardiovascular · 223d
Cleared Dec 18, 2022
INOUE BALLOON A
K220881 · OZT
Toray Industries, Inc.
Cardiovascular · 268d
Cleared Dec 15, 2022
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009)
K223472 · DRE
Spectranetics, Inc.
Cardiovascular · 28d
Cleared Dec 15, 2022
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
K221267 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 227d
Cleared Dec 14, 2022
PTA Balloon Dilatation Catheter
K221245 · LIT
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 226d
Cleared Dec 12, 2022
BioButton System
K212957 · DRG
Biolntellisense, Inc.
Cardiovascular · 452d
Cleared Dec 09, 2022
AIROS 6P Sequential Compression Device
K223195 · JOW
Airos Medical, Inc.
Cardiovascular · 57d
Cleared Dec 09, 2022
AIROS 8P Sequential Compression Device
K223193 · JOW
Airos Medical, Inc.
Cardiovascular · 57d
Cleared Dec 09, 2022
FloPatch FP120
K222242 · DPW
Flosonics Medical
Cardiovascular · 136d
Cleared Dec 09, 2022
Swang-Ganz IQ pulmonary artery catheter
K222117 · DYG
Edwards Lifesiences, LLC
Cardiovascular · 144d
Cleared Dec 08, 2022
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...
K222837 · MCW
Spectranetics, Inc.
Cardiovascular · 79d