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
16537–16560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2021
KHEIRON Spinal Fixation System
K211414 · NKB
S.M.A.I.O
Orthopedic · 96d
Cleared Aug 10, 2021
Ponto 5 Mini
K211640 · LXB
Oticon Medical AB
Ear, Nose, Throat · 75d
Cleared Aug 10, 2021
Biodentine XP 500, Biodentine XP 200
K211799 · KIF
Septodont
Dental · 61d
Cleared Aug 10, 2021
PSX Interbody System
K211873 · MAX
Alphatec Spine, Inc.
Orthopedic · 54d
Cleared Aug 09, 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use...
K211030 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 125d
Cleared Aug 09, 2021
X-CUBE 70
K211299 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 103d
Cleared Aug 09, 2021
X-CUBE 90
K211300 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 103d
Cleared Aug 09, 2021
Edma Synthetic Nitrile Examination Gloves
K211540 · LZA
Edma Group, LLC
General Hospital · 82d
Cleared Aug 08, 2021
Disposable Synthetic Vinyl Nitrile Examination Glove
K211354 · LYZ
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 97d
Cleared Aug 06, 2021
Kisses Plus Implant System
K200193 · NHA
Achimhai Medical Corporation
Dental · 557d
Cleared Aug 06, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity
K203136 · NOE
Diazyme Laboratories, Inc.
Chemistry · 290d
Cleared Aug 06, 2021
Tiger Reusable Sharps Container
K203305 · MMK
International Marketing Specialists,...
General Hospital · 270d
Cleared Aug 06, 2021
ClearCorrect System
K210320 · NXC
Clearcorrect, LLC
Dental · 183d
Cleared Aug 06, 2021
ulrichINJECT CT motion
K210541 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 163d
Cleared Aug 06, 2021
Nitrile Patient Examination Glove
K210725 · LZA
Pingan Medical Products Co., Ltd.
General Hospital · 149d
Cleared Aug 06, 2021
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable,...
K211202 · GWG
Stryker
Neurology · 106d
Cleared Aug 06, 2021
PAO Cortical Screw
K211435 · HWC
Medacta International S.A.
Orthopedic · 88d
Cleared Aug 06, 2021
Senographe Pristina
K211725 · MUE
Ge Healthcare
Radiology · 63d
Cleared Aug 06, 2021
Vereos PET/CT
K211764 · KPS
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Aug 06, 2021
TriMed Threaded Intramedullary Nail System
K211783 · HWC
TriMed, Inc.
Orthopedic · 58d
Cleared Aug 06, 2021
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K211784 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 58d
Cleared Aug 06, 2021
Kosmos
K212100 · IYN
EchoNous, Inc.
Radiology · 31d
Cleared Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
K200904 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 486d
Cleared Aug 05, 2021
ARK Lacosamide Assay
K201089 · NWM
ARK Diagnostics, Inc.
Toxicology · 469d