Search FDA 510(k) Devices

5,386 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
601–624 of 174,061
Cleared Jan 16, 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · DJG
Lin-Zhi International, Inc.
Toxicology · 115d
Cleared Jan 16, 2026
SOLIUS PRO UVB Light Panel
K252960 · SGZ
Solius Labs, Inc.
General & Plastic Surgery · 122d
Cleared Jan 16, 2026
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
K252775 · DHB
Hycor Biomedical
Immunology · 136d
Cleared Jan 16, 2026
actiTENS mini
K252767 · GZJ
Sublimed
Neurology · 140d
Cleared Jan 16, 2026
Imagine® Enterprise Suite
K252634 · QIH
Softlink International Private Limited
Radiology · 149d
Cleared Jan 16, 2026
Toro 88 Superbore Catheter
K252297 · QJP
Toro Neurovascular, Inc.
Neurology · 177d
Cleared Jan 16, 2026
Curiteva Porous PEEK Cervical Interbody System
K252205 · ODP
Curiteva, Inc.
Orthopedic · 186d
Cleared Jan 16, 2026
qXR-Detect
K251934 · MYN
Qure.Ai Technologies
Radiology · 206d
Cleared Jan 16, 2026
MY01 Continuous Compartmental Pressure Monitor
K251900 · LXC
MY01, Inc.
Orthopedic · 210d
Cleared Jan 16, 2026
SeptAlign
K251790 · NHB
Spirair, Inc.
Ear, Nose, Throat · 219d
Cleared Jan 16, 2026
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
K251744 · DTM
Medtronic
Cardiovascular · 224d
Cleared Jan 16, 2026
da Vinci Surgical System (IS5000)
K251739 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 224d
Cleared Jan 16, 2026
Xpert GI Panel
K251721 · PCH
Cepheid
Microbiology · 226d
Cleared Jan 16, 2026
Ion-C
K251714 · MRW
SurGenTec, LLC
Orthopedic · 227d
Cleared Jan 16, 2026
FL-10000U Respiratory Humidifier
K251448 · BTT
Flexicare Medical Limited.
Anesthesiology · 252d
Cleared Jan 16, 2026
OptoMonitor 3
K251367 · DXO
Opsens, Inc.
Cardiovascular · 260d
Cleared Jan 16, 2026
Eyer 2
K251353 · HKI
Phelcom Technologies
Ophthalmic · 261d
Cleared Jan 16, 2026
VITAL Tubing Sets for Hemodialysis
K251341 · FJK
Vital Healthcare Sdn. Bhd.
Gastroenterology & Urology · 261d
Cleared Jan 16, 2026
Tru Hematology Test
K251249 · GKZ
Truvian Sciences, Inc.
Hematology · 268d
Cleared Jan 16, 2026
WAVE Clinical Platform (2.0.000)
K250135 · MWI
Baxter Healthcare Corp/ Excel Medical
Cardiovascular · 364d
Cleared Jan 15, 2026
Curiteva Porous PEEK Cervical Interbody Fusion System
K254061 · ODP
Curiteva, Inc.
Orthopedic · 29d
Cleared Jan 15, 2026
TriMed Volar Bearing Plates (VBEAL-13-7S)
K254002 · HRS
TriMed, Inc.
Orthopedic · 31d
Cleared Jan 15, 2026
Aventus Thrombectomy System
K253925 · QEZ
Inquis Medical
Cardiovascular · 38d
Cleared Jan 15, 2026
MiniMed 780G Insulin Pump (MMT-1884)
K253470 · QFG
Medtronic Minimed, Inc.
Chemistry · 97d