Search FDA 510(k) Devices

5,480 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
1753–1776 of 3,225
Cleared Jun 17, 2025
Nano-Check Influenza+COVID-19 Dual Test
K243561 · SCA
Nano-Ditech Corporation
Microbiology · 211d
Cleared Jun 17, 2025
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested...
K243133 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 260d
Cleared Jun 17, 2025
VitalSigns 1-Lead Holter (VSH101)
K243003 · DXH
VitalSigns Technology Co., Ltd.
Cardiovascular · 264d
Not Cleared Jun 17, 2025
COAPTIUM Connect with TISSIUM LIGHT
DEN240066 · SFD
Tissium SA
Neurology · 208d
Not Cleared Jun 17, 2025
Oxiplex®
DEN240038 · QVL
Fziomed, Inc.
Orthopedic · 330d
Cleared Jun 16, 2025
X-PAC® TLIF Expandable Posterior Cage System
K251617 · MAX
Expanding Innovations, Inc.
Orthopedic · 20d
Cleared Jun 16, 2025
EvoEndo Single-Use Endoscopy System
K250900 · FDS
EvoEndo, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 16, 2025
Methinks NCCT Stroke
K250685 · QAS
Methinks Software, S.L
Radiology · 102d
Cleared Jun 16, 2025
MAGNETOM Avanto Fit
K250443 · LNH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jun 16, 2025
MAGNETOM Flow.Ace
K250436 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 122d
Cleared Jun 16, 2025
Mosaic (V1.0.1)
K244012 · LLZ
Navier Medical
Radiology · 172d
Cleared Jun 16, 2025
BD Veritor System for SARS-CoV-2
K243872 · QVF
Becton, Dickinson and Company
Microbiology · 181d
Cleared Jun 16, 2025
Silicone Urethral Catheter (Silicone Urethral Catheter)
K243011 · EZL
Guangdong Ecan Medical Co., Ltd.
Gastroenterology & Urology · 263d
Cleared Jun 16, 2025
Geo Abutment
K242978 · NHA
Geomedi Co,., Ltd.
Dental · 263d
Cleared Jun 16, 2025
Access hsTnI
K242870 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Jun 15, 2025
IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05,...
K243036 · OHT
Bestway Plastic and Metal Products ,...
General & Plastic Surgery · 261d
Cleared Jun 15, 2025
Bioptimal Bipolar Pacing Catheter
K242863 · LDF
Bioptimal International Pte. , Ltd.
Cardiovascular · 268d
Cleared Jun 15, 2025
Withings ECG App
K240795 · QDA
Withings
Cardiovascular · 450d
Cleared Jun 13, 2025
Excipio LV Prime Thrombectomy Device
K251485 · QEW
Contego Medical, Inc.
Cardiovascular · 30d
Cleared Jun 13, 2025
Aventus Thrombectomy System
K251189 · QEW
Inquis Medical
Cardiovascular · 57d
Cleared Jun 13, 2025
Mfinity Femoral System
K251166 · MEH
Medacta International S.A.
Orthopedic · 59d
Cleared Jun 13, 2025
3 in 1 TENS UNIT
K250759 · NGX
Changsha Anxiang Medical Technology...
Physical Medicine · 92d
Cleared Jun 13, 2025
Vessel Sealer Curved (480522)
K250674 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 99d
Cleared Jun 13, 2025
Accuro® 3S Needle Guide Kit
K250469 · ITX
Rivanna Medical, Inc.
Radiology · 115d