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
10633–10656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2023
RevCore™ Thrombectomy Catheter.
K223609 · QEW
Inari Medical, Inc.
Cardiovascular · 102d
Cleared Mar 14, 2023
Cervical Plate System
K223753 · KWQ
Double Medical Technology, Inc.
Orthopedic · 90d
Cleared Mar 14, 2023
SofWave System
K230019 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 70d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 13, 2023
Surgical Face Mask
K221352 · FXX
Wuhan Huashida Protective Products...
General Hospital · 307d
Cleared Mar 13, 2023
Aarhus Applicator Set
K222775 · JAQ
Varian Medical Systems, Inc.
Radiology · 180d
Cleared Mar 13, 2023
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
K222954 · LPL
Innova Vision, Inc.
Ophthalmic · 167d
Cleared Mar 13, 2023
Omnia Medical Coupler-C Anterior Cervical Plate
K223321 · KWQ
Omnia Medical, LLC
Orthopedic · 133d
Cleared Mar 13, 2023
Remi Robotic Navigation System
K223350 · OLO
Fusion Robotics, LLC
Orthopedic · 131d
Cleared Mar 12, 2023
High Protection Surgical Gown
K222456 · FYA
3A Medical Products Co., Ltd.
General Hospital · 209d
Cleared Mar 10, 2023
Avoset Infusion Pump System
K213744 · FRN
Eitan Medical , Ltd.
General Hospital · 466d
Cleared Mar 10, 2023
Aristotle 14 Guidewire
K220398 · MOF
Scientia Vascular, LLC
Neurology · 392d
Cleared Mar 10, 2023
CloudTMS for OCD
K221129 · QCI
Teleemg, LLC
Neurology · 326d
Cleared Mar 10, 2023
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution...
K221198 · NGZ
Thermo Fisher Scientific
Microbiology · 318d
Cleared Mar 10, 2023
Uni Knee Resurfacing System
K221292 · HSX
Overture Resurfacing, Inc.
Orthopedic · 310d
Cleared Mar 10, 2023
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
K221623 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 277d
Cleared Mar 10, 2023
BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device
K222478 · JKA
Becton, Dickinson and Company
General Hospital · 206d
Cleared Mar 10, 2023
Vial Adapter
K222718 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 183d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Mar 10, 2023
uMI Panorama
K223325 · KPS
Shanghai United Imaging Healthcare...
Radiology · 130d
Cleared Mar 10, 2023
ATTUNE® Revision Cones
K230295 · MBH
Depuy Ireland UC
Orthopedic · 36d
Cleared Mar 10, 2023
Lyra RSV+hMPV Assay
K230349 · OEM
Quidel Corporation
Microbiology · 29d
Cleared Mar 10, 2023
Arthrex Knotless FiberTak Suture Anchor
K230433 · MBI
Arthrex, Inc.
Orthopedic · 21d
Cleared Mar 09, 2023
DESS Dental Smart Solutions
K221301 · NHA
Terrats Medical SL
Dental · 308d