Search FDA 510(k) Devices

5,381 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
169–192 of 3,225
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 237d
Cleared Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
K250925 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 264d
Cleared Dec 15, 2025
V•Stick™ Vascular Access Set
K253741 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 21d
Cleared Dec 15, 2025
Tembo Embolic System
K253677 · KRD
Instylla, Inc.
Cardiovascular · 24d
Cleared Dec 15, 2025
FemVue® Controlled Saline-Air Device (FSA-300)
K253403 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 76d
Cleared Dec 15, 2025
HyperVue™ Imaging System - Integrated
K253101 · NQQ
Spectrawave, Inc.
Cardiovascular · 82d
Cleared Dec 15, 2025
Paradigm System
K252950 · OLO
Proprio, Inc.
Orthopedic · 90d
Cleared Dec 15, 2025
Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml,...
K252935 · NUC
Foshan Pingchuang Medical Technology...
Obstetrics & Gynecology · 91d
Cleared Dec 15, 2025
Triathlon® Tritanium® Asymmetric Patella
K252898 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 95d
Cleared Dec 15, 2025
da Vinci SP Surgical System (SP1098)
K252675 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Dec 15, 2025
Erchonia CLX (Model # CFL)
K252574 · OLI
Erchonia Corporation
General & Plastic Surgery · 123d
Cleared Dec 15, 2025
SleepRes PAP System
K251770 · BZD
Sleepres, Inc.
Anesthesiology · 188d
Cleared Dec 15, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System
K251302 · OQB
Spineology, Inc.
Orthopedic · 231d
Cleared Dec 15, 2025
MFUSE (MS001)
K250319 · QSY
Machina Medical, Inc.
General & Plastic Surgery · 314d
Cleared Dec 14, 2025
Hypnos (369054-200)
K250851 · OLZ
Cadwell Industries, Inc.
Neurology · 268d
Cleared Dec 12, 2025
Affixus® Natural Nail® Proximal Humeral System
K253749 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 17d
Cleared Dec 12, 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · QSY
Cresilon, Inc.
General & Plastic Surgery · 24d
Cleared Dec 12, 2025
Swoop® Portable MR Imaging® System
K253489 · LNH
Hyperfine, Inc.
Radiology · 49d
Cleared Dec 12, 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 101d
Cleared Dec 12, 2025
Halo Sterile Single-use Radial Fiber...
K252745 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 105d
Cleared Dec 12, 2025
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 109d
Cleared Dec 12, 2025
Revi System
K252391 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 134d