Search FDA 510(k) Devices

5,463 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
1825–1848 of 3,129
Cleared Jun 10, 2024
OmniTom Elite
K233767 · JAK
Neurologica Corporation
Radiology · 199d
Cleared Jun 10, 2024
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection]...
K232911 · FGB
Karl Storz Endovision, Inc.
Gastroenterology & Urology · 265d
Cleared Jun 07, 2024
Access Thyroglobulin
K241423 · MSW
Beckman Coulter, Inc.
Immunology · 18d
Cleared Jun 07, 2024
iLoop Interventional Coil 0.55T
K241069 · MOS
Noras Mri Products GmbH
Radiology · 49d
Cleared Jun 07, 2024
Cardiac CT Function Software Application
K241038 · QIH
Circle Cardiovascular Imaging
Radiology · 52d
Cleared Jun 07, 2024
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
K240972 · NLH
Surgical Instrument Service and...
Cardiovascular · 59d
Cleared Jun 07, 2024
Blood Pressure Monitor (BBZ32-AA01)
K240832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 73d
Cleared Jun 07, 2024
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST,...
K240672 · EIH
Zhejiang Zahndent Biotechnology Co.,...
Dental · 88d
Cleared Jun 07, 2024
IPD Dental Implant Abutments
K240570 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 99d
Cleared Jun 07, 2024
Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
K234099 · NUC
Select Labs, LLC
Obstetrics & Gynecology · 164d
Cleared Jun 07, 2024
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K234042 · QIH
Ever Fortune.Ai, Co., Ltd.
Radiology · 169d
Cleared Jun 07, 2024
Libre Rio Continuous Glucose Monitoring System
K233861 · SBH
Abbott Diabetes Care
Chemistry · 184d
Cleared Jun 07, 2024
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K233825 · NLH
Innovative Health
Cardiovascular · 189d
Cleared Jun 07, 2024
Disposable Hemostatic Clips
K232969 · PKL
Ningbo Xinwell Medical Technology...
Gastroenterology & Urology · 260d
Cleared Jun 07, 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
K232963 · NGZ
bioMerieux, Inc.
Microbiology · 260d
Cleared Jun 07, 2024
Uro-G HD Flexible Cystoscope
K232837 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 267d
Cleared Jun 07, 2024
Electrocardiograph, model: ECG301
K232816 · DPS
Shenzhen LE Medical Technology Co., Ltd.
Cardiovascular · 268d
Cleared Jun 07, 2024
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft...
K232806 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 269d
Cleared Jun 07, 2024
FibriCheck
K232804 · QME
Qompium NV
Cardiovascular · 269d
Cleared Jun 07, 2024
Steriking® Pouch for Robotic Instruments
K232625 · FRG
Wipak OY
General Hospital · 283d
Cleared Jun 07, 2024
Impala
K232035 · DPS
AliveCor, Inc.
Cardiovascular · 336d
Cleared Jun 07, 2024
Corvair
K231010 · MHX
AliveCor, Inc.
Cardiovascular · 427d
Cleared Jun 06, 2024
WaveSense Jazz Blood Glucose Monitoring System
K241304 · NBW
Agamatrix
Chemistry · 28d
Cleared Jun 06, 2024
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 58d