FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
18241–18264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2021
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation...
K203465 · HTY
OSSIO , Ltd.
Orthopedic · 43d
Cleared Jan 06, 2021
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood...
K203652 · DXQ
Jkh USA, LLC
Cardiovascular · 23d
Cleared Jan 05, 2021
Insulin Syringe
K193273 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 406d
Cleared Jan 05, 2021
Fixone Biocomposite Interference Screw
K193497 · HWC
Aju Pharm Co., Ltd.
Orthopedic · 385d
Cleared Jan 05, 2021
Non-contact Infrared Body Thermometer, model:HTD8823US
K200159 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 349d
Cleared Jan 05, 2021
ABI Instrument, Creo Electrosurgical System
K200298 · NEY
Creo Medical, Ltd.
General & Plastic Surgery · 334d
Cleared Jan 05, 2021
Bfix Orthopedic External Fixator Systems
K200491 · KTT
Aike (Shanghai) Medical Instrument...
Orthopedic · 312d
Cleared Jan 05, 2021
Halo Single-Loop Microsnare Kit
K200963 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 270d
Cleared Jan 05, 2021
Bidop 7
K201114 · DPW
Koven Technology, Inc.
Cardiovascular · 253d
Cleared Jan 05, 2021
NeutrArt
K201872 · FPA
Asset Medikal Tasarim As.
General Hospital · 182d
Cleared Jan 05, 2021
iHealth Clinical Digital Thermometer
K202791 · FLL
Andon Health Co, Ltd.
General Hospital · 105d
Cleared Jan 05, 2021
ClearPath Aligner
K202857 · NXC
Clearpath Orthodontics, Ltd.
Dental · 99d
Cleared Jan 04, 2021
Disposable Medical Face Masks
K202719 · FXX
Jiangxi Sanxin Medtec Co., Ltd.
General Hospital · 109d
Cleared Jan 04, 2021
J-Plasma Precise FLEX Handpiece
K202880 · GEI
Apyx Medical Corporation(Formerly...
General & Plastic Surgery · 98d
Cleared Jan 04, 2021
ChoiceSpine Navigation System
K203561 · OLO
Choice Spine, LLC
Orthopedic · 28d
Cleared CT Jan 02, 2021
Sparrow Therapy System
K201873 · PZR
Spark Biomedical, Inc.
Neurology · 179d
Cleared Dec 31, 2020
NuEra Tight Family, EMS Model
K201239 · NGX
Bios S.R.L.
Physical Medicine · 238d
Cleared Dec 31, 2020
HANAROSTENT Trachea/Bronchium (CCC)
K201342 · JCT
M.I. Tech Co., Ltd.
Anesthesiology · 225d
Cleared Dec 31, 2020
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18...
K202267 · KXK
Isoray Medical, Inc.
Radiology · 142d
Cleared Dec 31, 2020
Sim&Size
K202322 · PZO
Sim&Cure
Neurology · 136d
Cleared Dec 31, 2020
Nordiwell Medical Face Mask
K202615 · FXX
Changzhou Combat Protective Equipment...
General Hospital · 113d
Cleared Dec 31, 2020
Promisemed Covered Safety Pen Needle
K202681 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 107d
Cleared Dec 31, 2020
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
K202706 · FYA
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT...
General Hospital · 106d
Cleared Dec 30, 2020
NeuroAmp II, NeuroAmp II.5s
K193159 · GWQ
Corscience GmbH & Co. KG
Neurology · 411d