FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2473–2496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 25, 2025
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye...
K243785 · BTR
Covidien, LLC
Anesthesiology · 290d
Cleared Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...
K252703 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Sep 24, 2025
MEDRAD Centargo CT Injection System
K252689 · IZQ
Imaxeon Pty, Ltd.
General Hospital · 29d
Cleared Sep 24, 2025
LenSx Laser System (8065000944)
K252682 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Sep 24, 2025
Celerity™ 20 HP Biological Indicator
K252680 · FRC
STERIS Corporation
General Hospital · 30d
Cleared Sep 24, 2025
Pounce(TM) Sheath
K252227 · DYB
Surmodics,Inc.
Cardiovascular · 70d
Cleared Sep 24, 2025
Resitu Slider 09 (RESL09)
K252183 · KNW
Resitu Medical AB
General & Plastic Surgery · 75d
Cleared Sep 24, 2025
ProVee Video Processing Unit (PV-003)
K251734 · FET
Proverum Limited
Gastroenterology & Urology · 110d
Cleared Sep 24, 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · MUH
Dentimax, Inc.
Radiology · 159d
Cleared Sep 24, 2025
t:slim X2 insulin pump with interoperable technology
K250792 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 194d
Cleared Sep 24, 2025
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
K250071 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 257d
Cleared Sep 24, 2025
uWS-Angio Pro
K250045 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 257d