Search FDA 510(k) Database

6,828 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14785–14808 of 174,061
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
Cleared Aug 05, 2021
NeuroSENSE Monitoring System, Model NS-901
K202621 · OLW
Neurowave Systems, Inc.
Anesthesiology · 329d
Cleared Aug 05, 2021
Biomet Microfixation OmniMax MMF System
K202969 · JEY
Biomet Microfixation
Dental · 309d
Cleared Aug 05, 2021
R2 Dermabrasion Tip (for Dermal Cooling System)
K203006 · QPZ
R2 Technologies, Inc.
General & Plastic Surgery · 308d
Cleared Aug 05, 2021
TRACOE vario
K203362 · JOH
Tracoe Medical GmbH
Anesthesiology · 262d
Cleared Aug 05, 2021
Harmony Latex Dam, Harmony Non-Latex Dam
K203727 · MSC
Pamco Distributing, Inc.
Obstetrics & Gynecology · 227d
Cleared Aug 05, 2021
AcQMap High Resolution Imaging and Mapping System
K210680 · DQK
Acutus Medical, Inc.
Cardiovascular · 150d
Cleared Aug 05, 2021
Disposable Medical Nitrile Examination Gloves (Non-Sterile)
K211075 · LZA
Jiangsu Cherish Medical Technology...
General Hospital · 115d