Search FDA 510(k) Devices

5,369 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
337–360 of 174,061
Cleared Feb 23, 2026
SKIA-Head (Model: SKIA-ST00)
K253486 · LLZ
Skia, Inc.
Radiology · 129d
Cleared Feb 23, 2026
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
K253244 · IZL
Poskom Co., Ltd.
Radiology · 147d
Cleared Feb 23, 2026
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
K253228 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 147d
Cleared Feb 23, 2026
Duet™ Spinal Fixation System
K253169 · NKB
Box Spine, LLC
Orthopedic · 150d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068 · FMF
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Feb 23, 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy...
K252795 · KNW
Argon Medical Devices, Inc.
General & Plastic Surgery · 174d
Cleared Feb 23, 2026
Rubber Utility Catheter
K251864 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 251d
Cleared Feb 23, 2026
Mariana Minerva
K251661 · MNS
Resmed Pty , Ltd.
Anesthesiology · 269d
Cleared Feb 23, 2026
VITA VMLC Primer
K251587 · KLE
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Dental · 276d
Cleared Feb 22, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d
Cleared Feb 21, 2026
Advanced Tissue Resection Device
K251692 · FDI
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Feb 20, 2026
LF Process Indicator Tape for Steam Sterilization
K260181 · JOJ
Intertape Polymer Group
General Hospital · 30d
Cleared Feb 20, 2026
KLS Martin Ixos System
K254162 · HRS
KLS-Martin L.P.
Orthopedic · 60d
Cleared Feb 20, 2026
FAQ™ (LED Panel)
K253683 · OHS
Foreo, Inc.
General & Plastic Surgery · 91d
Cleared Feb 20, 2026
KLS Martin Pure Pectus System
K253660 · HRS
KLS-Martin L.P.
Orthopedic · 92d
Cleared Feb 20, 2026
Xpert Hemorrhagic Fever
K253653
Cepheid
Microbiology · 92d
Cleared Feb 20, 2026
Safety Heel Lancet
K253605 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 94d
Cleared Feb 20, 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445 · FQH
Bd
General & Plastic Surgery · 141d
Cleared Feb 20, 2026
“POINT” Kinguide Agile Hybrid Navigation System
K252989 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 155d
Cleared Feb 20, 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · DQK
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Feb 20, 2026
CaseBio™ Culture w/HSA (CMH5)
K252672 · MQL
Casebioscience, Inc.
Obstetrics & Gynecology · 179d
Cleared Feb 20, 2026
QSCHECK UISACR
K252619 · JFY
Qstag, Inc.
Chemistry · 185d
Cleared Feb 20, 2026
CARA System
K252500 · OWB
Cara Medical, Ltd.
Radiology · 196d
Cleared Feb 20, 2026
Disposable Ureteral Stents
K251890 · FAD
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 245d