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: 2023–2023 ×
3,347 results
3241–3264 of 3,347
Search insights Median review: 139d Cleared: 99% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Orthopedic
Cleared Jan 18, 2023
eXciteOSA without remote control (3000)
K223446 · QNO
Signifier Medical Technologies, Ltd.
Dental · 64d
Cleared Jan 18, 2023
MOLLI 2
K223107 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 110d
Cleared Jan 18, 2023
TruPlan Computed Tomography (CT) Imaging Software
K222593 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 145d
Cleared Jan 18, 2023
Transit-Pellets
K222000 · FFX
Medifactia AB
Gastroenterology & Urology · 195d
Cleared Jan 18, 2023
Uni-FuZe-C Bone Strip
K221726 · MQV
Zavation Medical Products, LLC
Orthopedic · 218d
Cleared Jan 18, 2023
Anatomic Bone Plate
K221088 · HRS
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 18, 2023
MultiCut Solo
K213597 · GCJ
Asclepion Laser Technologies GmbH
Obstetrics & Gynecology · 432d
Cleared Jan 18, 2023
Selux AST System
K211759 · LON
Selux Diagnostics, Inc.
Microbiology · 590d
Cleared Jan 17, 2023
MIM – Additional Tracers
K223800 · LLZ
Mim Software, Inc.
Radiology · 29d
Cleared Jan 17, 2023
FairFix QT Adjustable Button
K223795 · MBI
Medacta International S.A.
Orthopedic · 29d
Cleared Jan 17, 2023
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K223794 · OAS
Cefla S.C.
Radiology · 29d
Cleared Jan 17, 2023
Plasma IQ
K223222 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 92d
Cleared Jan 17, 2023
Portable X-ray System
K223010 · EHD
Iray Technology Taicang , Ltd.
Radiology · 110d
Cleared Jan 17, 2023
Halcyon, Ethos Radiotherapy System
K222941 · IYE
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
K221754 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 215d
Cleared Jan 17, 2023
Disposable Endoscope Valve Sets
K220884 · ODC
Sml Med-Tech Solutions Limited
Gastroenterology & Urology · 295d
Cleared Jan 17, 2023
Elucis
K220649 · LLZ
Realize Medical, Inc.
Radiology · 316d
Cleared Jan 17, 2023
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
K213655 · IPF
Hilltek, LLC
Physical Medicine · 424d
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748 · LZA
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 13, 2023
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K223746 · NCX
Zoll Circulation, Inc.
Neurology · 30d
Cleared Jan 13, 2023
MR Diffusion Perfusion Mismatch V1.0
K223502 · LLZ
Olea Medical
Radiology · 53d
Cleared Jan 13, 2023
Medipoint Blood Lancets
K223480 · QRK
Medipoint Holdings, LLC
General & Plastic Surgery · 56d
Cleared Jan 13, 2023
PathLoc-TA Expandable Lumbar Cage System
K223474 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Jan 13, 2023
Contour Knee
K223429 · MOS
Quality Electrodynamics, LLC
Radiology · 60d