Search FDA 510(k) Devices

5,422 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
841–864 of 3,225
Cleared Sep 26, 2025
FUJIFILM Stiffening Wire Device (SW-2000)
K251204 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 161d
Cleared Sep 26, 2025
LoFric Origo
K250659 · EZD
Wellspect AB
Gastroenterology & Urology · 205d
Cleared Sep 26, 2025
Planmed XFI
K250318 · SFV
Planmed OY
Radiology · 234d
Cleared Sep 26, 2025
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093 · BZQ
Linshom Medical, Inc.
Anesthesiology · 255d
Cleared Sep 25, 2025
Stem Extension Line (U2 Total Knee System—PSA Type)
K252725 · JWH
United Orthopedic Corporation
Orthopedic · 28d
Cleared Sep 25, 2025
uMR 680
K252371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Sep 25, 2025
Alinity m HCV
K252102 · MZP
Abbott Molecular, Inc.
Microbiology · 84d
Cleared Sep 25, 2025
Medical Diode Laser Systems (BERYLAS-12N)
K252063 · GEX
Wuhan Dimed Laser Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Sep 25, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252062 · JWY
Thermo Fisher Scientific
Microbiology · 86d
Cleared Sep 25, 2025
EnSite™ X EP System
K252013 · DQK
Abbott Medical
Cardiovascular · 90d
Cleared Sep 25, 2025
Single-Use Biopsy Valve (MAJ-1555)
K251997 · OCX
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Sep 25, 2025
Panther Fusion GI Expanded Bacterial Assay
K251993 · PCH
Hologic, Inc.
Microbiology · 90d
Cleared Sep 25, 2025
RPS Primary TKA Software
K251971 · OLO
Stryker Instruments
Orthopedic · 91d
Cleared Sep 25, 2025
Panther Fusion GI Bacterial Assay
K251868 · PCH
Hologic
Microbiology · 99d
Cleared Sep 25, 2025
Steripath® Flow™ Blood Collection System
K251812 · JKA
Magnolia Medical Technologies
General Hospital · 105d
Cleared Sep 25, 2025
Auxano® Wedge Fixation System
K251791 · PLF
Auxano Medical, LLC
Orthopedic · 106d
Cleared Sep 25, 2025
EMBOTRAP III Revascularization Device
K251789 · NRY
Neuravi Limited
Neurology · 106d
Cleared Sep 25, 2025
Brain WMH
K251527 · QIH
Quantib B.V.
Radiology · 129d
Cleared Sep 25, 2025
Hi bebe super (BT-150B)
K251512 · HGX
Bistos Co., Ltd.
Obstetrics & Gynecology · 132d
Cleared Sep 25, 2025
Root canal repair materials (nRoot BP)
K251465 · KIF
Enpuno Biotechnology Co., Ltd.
Dental · 135d
Cleared Sep 25, 2025
JDEvolution Plus L and JDEvolution Plus LE
K251148 · DZE
Jdentalcare Srl
Dental · 164d
Cleared Sep 25, 2025
Pulse Oximeter
K250837 · DQA
Shanghai Berry Electronic Tech Co., Ltd.
Anesthesiology · 189d
Cleared Sep 25, 2025
Endeavor™ Stand-Alone Cervical IBF System
K250076 · OVE
Innovasis
Orthopedic · 258d
Cleared Sep 25, 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens...
K244009 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 273d