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
12457–12480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 112d
Cleared Aug 19, 2022
Cortera Spinal Fixation System
K221403 · NKB
Surgalign Spine Technologies
Orthopedic · 95d
Cleared Aug 19, 2022
OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33),...
K221824 · OCX
Cipher Surgical Limited
Gastroenterology & Urology · 57d
Cleared Aug 19, 2022
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
K221848 · QLQ
Centinel Spine, LLC
Orthopedic · 56d
Cleared Aug 19, 2022
Stent Positioning Assistance System (SPAS)
K221917 · DQX
Seven Sons , Ltd.
Cardiovascular · 50d
Cleared Aug 19, 2022
1688 4K Camera System with Advanced Imaging Modality
K222130 · GCJ
Stryker
General & Plastic Surgery · 32d
Cleared Aug 19, 2022
MI View&GO
K222172 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 19, 2022
Baby Gorilla®/Gorilla® Plating System
K222194 · HRS
Paragon 28, Inc.
Orthopedic · 28d
Cleared Aug 19, 2022
SmartBolus Calculator
K222239 · QRX
Insulet Corporation
Chemistry · 24d
Cleared Aug 18, 2022
Bio-MEM Ti Reinforced Membrane
K210797 · NPK
B&Medi Co., Ltd.
Dental · 520d
Cleared Aug 18, 2022
Jeesung Safety Syringe and Single Use Needles
K212518 · MEG
Jeesung Medical Co., Ltd.
General Hospital · 373d
Cleared Aug 18, 2022
iClean Viral Transport System (VTM-RT kit)
K212856 · JSM
Huachenyang (Shenzhen) Technology Co....
Microbiology · 344d
Cleared Aug 18, 2022
Sotair Device
K212905 · BTM
Safe Bvm Corporation
Anesthesiology · 339d
Cleared Aug 18, 2022
Benchmark BMX96 Access System
K213390 · QJP
Penumbra, Inc.
Neurology · 307d
Cleared Aug 18, 2022
GuideLiner Coast, 5.5F (5270)
K220647 · DQY
Vascular Solutions, LLC
Cardiovascular · 164d
Cleared Aug 18, 2022
OR3O Dual Mobility System
K220959 · LPH
Smith & Nephew, Inc.
Orthopedic · 139d
Cleared Aug 18, 2022
EnSite X EP System
K221213 · DQK
Abbott
Cardiovascular · 113d
Cleared Aug 18, 2022
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen...
K221353 · DWF
Qura S.R.L
Cardiovascular · 100d
Cleared Aug 18, 2022
Miro3D Wound Matrix
K221520 · KGN
Reprise Biomedical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 18, 2022
truFreeze Console, PN CC301
K222272 · GEH
STERIS Corporation
General & Plastic Surgery · 20d
Cleared Aug 17, 2022
implaFit® hip stems
K210678 · LZO
Implantcast GmbH
Orthopedic · 530d
Cleared Aug 17, 2022
Disposable Sterile Syringe, with/without needle
K212033 · FMF
Shandong Zhushi Pharmaceutical Group...
General Hospital · 414d
Cleared Aug 17, 2022
Cross Protection ResQ300 Plus Surgical Face Mask
K212273 · FXX
Cross Protection (M) Sdn Bhd
General Hospital · 393d
Cleared Aug 17, 2022
Disposable Blood Lancets
K220387 · QRL
Suzhou Kyuan Medical Apparatus Co., Ltd.
General & Plastic Surgery · 188d