Search FDA 510(k) Database

6,663 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
11641–11664 of 174,061
Cleared Aug 10, 2022
BLT Dental Implant System
K212364 · DZE
Bio Concept Co., Ltd.
Dental · 376d
Cleared Aug 10, 2022
UniVit HE, UniVit UHS
K212763 · HQE
Visioncare Devices, LLC
Ophthalmic · 344d
Cleared Aug 10, 2022
CytonPro-5000
K213524 · ILY
Cytonsys, Inc.
Physical Medicine · 280d
Cleared Aug 10, 2022
iSyncWave
K220056 · GWQ
iMediSync, Inc.
Neurology · 216d
Cleared Aug 10, 2022
Safety Blood Collection Needles with/without Needle Holder
K220900 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d
Cleared Aug 10, 2022
KDG Abutments
K221381 · NHA
Keystone Dental, Inc.
Dental · 89d
Cleared Aug 10, 2022
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
K221879 · MHX
Caf Medical Solutions, Inc.
Cardiovascular · 43d
Cleared Aug 09, 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue,...
K212482 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 365d
Cleared Aug 09, 2022
NOVA RESIN dual cure, self adhesive resin cement
K213609 · EMA
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 267d
Cleared Aug 09, 2022
IMICRYL Composite, Composite Flow Materials
K220077 · EBF
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 211d
Cleared Aug 09, 2022
“POINT” Kinguide Robotic-Assisted Surgical System
K220241 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 193d
Cleared Aug 09, 2022
NextGen Pedicle Screw System
K221776 · NKB
Corelink, LLC
Orthopedic · 49d
Cleared Aug 09, 2022
IRIS Pi Q switched Nd YAG laser
K221789 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 49d
Cleared Aug 09, 2022
LimFlow V-Ceiver
K222083 · MMX
LimFlow, Inc.
Cardiovascular · 25d
Cleared Aug 09, 2022
DenMat Glutaraldehyde Desensitizer
K222357 · KLE
Denmat Holding, LLC
Dental · 5d
Cleared Aug 08, 2022
Dasky Disposable Sampling Tube (Model name: VSM02)
K211675 · QBD
Ningbo Dasky Life Science Co., Ltd.
Microbiology · 433d
Cleared Aug 08, 2022
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
K212243 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Aug 08, 2022
ClearPoint Maestro Brain Model
K213645 · QIH
ClearPoint Neuro, Inc.
Radiology · 263d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 3.0T Coil
K213727 · MOS
Invivo Corporation (Business Trade...
Radiology · 255d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 1.5T Coil
K213735 · MOS
Invivo Corporation (Business Trade...
Radiology · 252d
Cleared Aug 08, 2022
Dental Impression Material
K221668 · ELW
Chemoment Materials Co.,Ltd
Dental · 61d
Cleared Aug 08, 2022
Dolphin Imaging 12.0
K222072 · LLZ
Patterson Dental Supply, Inc.
Radiology · 25d
Cleared Aug 06, 2022
Pro Guard Nitrile Powder Free Examination Glove
K213934 · LZA
Medical Glove Co., Ltd.
General Hospital · 233d
Cleared Aug 06, 2022
Reprocesses Umbilical Cable
K221854 · NLH
Innovative Health, LLC
Cardiovascular · 40d