Search FDA 510(k) Devices

5,446 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1561–1584 of 174,061
Cleared Sep 26, 2025
AUXILIARY WATER TUBE MAJ-855
K251986 · OCX
Olympus Medical Systems Corporation
Gastroenterology & Urology · 91d
Cleared Sep 26, 2025
Thulium Laser System (Deluxlase)
K251919 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 95d
Cleared Sep 26, 2025
Self-Propelled CT Scan Base Kit, CGBA-035A
K251645 · JAK
Canon Medical Systems Corporation
Radiology · 120d
Cleared Sep 26, 2025
VitalStream ART Connect
K251275 · DXG
Caretaker Medical
Cardiovascular · 155d
Cleared Sep 26, 2025
S.I.N. Dental Implant System
K251262 · DZE
S.I.N. Implant System Ltda
Dental · 156d
Cleared Sep 26, 2025
Tuned Self-Fitting Mobile App
K251208 · SCR
Tuned , Ltd.
Ear, Nose, Throat · 161d
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