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
1153–1176 of 18,110
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