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
9553–9576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2023
Neodent Implant System - Zirconia Implant System
K222026 · NHA
Jjgc Industria E Comercio DE...
Dental · 368d
Cleared Jul 14, 2023
Bonafix TiBase
K221673 · NHA
Zentek Medical, LLC
Dental · 400d
Cleared Jul 14, 2023
i-STAT PTplus Cartridge with the i-STAT 1 System
K220282 · GJS
Abbott Laboratories
Hematology · 528d
Cleared Jul 13, 2023
Biograph Vision.X and Biograph Vision.X Edge
K231833 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 21d
Cleared Jul 13, 2023
activL® Next Generation Instrumentation
K231769 · QLQ
Aesculap Implants Systems, LLC
Orthopedic · 27d
Cleared Jul 13, 2023
Praxiject™ 0.9% NaCl
K231754 · NGT
Medxl, Inc.
General Hospital · 28d
Cleared Jul 13, 2023
Portable X-ray System Model Ray98(P)
K231449 · EHD
Ningbo Runyes Medical Instrument Co.,...
Radiology · 56d
Cleared Jul 13, 2023
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
K231438 · MAX
Alphatec Spine, Inc.
Orthopedic · 57d
Cleared Jul 13, 2023
Chondral Quant
K231351 · LLZ
Siemens Medical Soultions USA, Inc.
Radiology · 65d
Cleared Jul 13, 2023
ReddyPort Elbow
K231064 · MNS
Smd Manufacturing, LLC
Anesthesiology · 90d
Cleared Jul 13, 2023
Admira Fusion 5
K230877 · EBF
Voco GmbH
Dental · 105d
Cleared Jul 13, 2023
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System
K230863 · LSR
Zeus Scientific
Microbiology · 106d
Cleared Jul 13, 2023
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
K230611 · JAD
Xstrahl, Ltd.
Radiology · 129d
Cleared Jul 13, 2023
Micro Rx
K223728 · DQY
Imds Operations B.V.
Cardiovascular · 212d
Cleared Jul 13, 2023
ECHELON Synergy MRI system
K223426 · LNH
Fujifilm Healthcare Corporation
Radiology · 241d
Cleared Jul 13, 2023
Spine Auto Views
K223424 · JAK
GE Medical Systems SCS
Radiology · 241d
Cleared Jul 13, 2023
Open Rib
K223261 · JAK
Canon Medical Informatics, Inc.
Radiology · 262d
Cleared Jul 13, 2023
XR90 (XR90-SYS)
K223125 · LLZ
Mediview Xr, Inc.
Radiology · 283d
Cleared Jul 13, 2023
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra...
K222116 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 360d
Cleared Jul 13, 2023
HydroMARK Plus Breast Biopsy Site Marker
K221961 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 373d
Cleared Jul 12, 2023
Graftys Quickset
K231714 · MQV
Graftys
Orthopedic · 30d
Cleared Jul 12, 2023
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
K231709 · MQB
Radmedix, LLC
Radiology · 30d
Cleared Jul 12, 2023
NanoHive Medical Lumbar Interbody System
K231241 · MAX
NanoHive Medical, LLC
Orthopedic · 75d
Cleared Jul 12, 2023
FusedCO Algorithm
K231035 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 92d