Search FDA 510(k) Database

6,865 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
15889–15912 of 174,061
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K203295 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K203296 · LSR
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Capture-CMV
K203612 · LJO
Immucor, Inc.
Microbiology · 102d
Cleared Mar 22, 2021
Spark Clear Aligner System
K203737 · NXC
Ormco Corporation
Dental · 90d
Cleared Mar 21, 2021
Movement and Compressions System (the MAC System)
K203052 · JOW
Recovery Force, LLC
Cardiovascular · 165d
Cleared Mar 19, 2021
ZIDA Wearable Neuromodulation System
K192731 · NAM
Exodus Innovations
Gastroenterology & Urology · 539d
Cleared Mar 19, 2021
Sovereign America Surgical Face Mask
K201095 · FXX
Homtex, Inc.
General Hospital · 329d
Cleared Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis...
K202081 · LZA
Shen Wei (Usa), Inc.
General Hospital · 235d
Cleared Mar 19, 2021
Invacare AVIVA Storm RX Power Chair
K202379 · ITI
Invacare Corporation
Physical Medicine · 211d
Cleared Mar 19, 2021
Disposable Medical Face Mask
K202628 · FXX
Qinghai Zhong Dao Win-Win Medical...
General Hospital · 189d
Cleared Mar 19, 2021
LightWalker Laser System Family
K202985 · GEX
Fotona D.O.O.
General & Plastic Surgery · 170d
Cleared Mar 19, 2021
SensorX
K203116 · MUH
Durr Dental SE
Radiology · 154d
Cleared Mar 19, 2021
VBrain
K203235 · QKB
Vysioneer, Inc.
Radiology · 136d
Cleared Mar 19, 2021
Patient Examination Gloves
K203593 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 100d
Cleared Mar 19, 2021
BonOs HV, BonOs MV, BonOs LV
K210120 · LOD
Osartis GmbH
Orthopedic · 59d
Cleared Mar 19, 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
K210125 · LOD
Osartis GmbH
Orthopedic · 59d
Cleared Mar 19, 2021
SPINEART Navigation Instrument System
K210472 · OLO
Spineart
Orthopedic · 30d
Cleared Mar 19, 2021
IMPACT and X-Ranger
K210479 · IZL
Minxray, Inc.
Radiology · 28d
Cleared Mar 18, 2021
Clarus Peel-Away Introducer Sheath
K200925 · GWG
Clarus Medical, LLC
Neurology · 345d
Cleared Mar 18, 2021
Spin Care Disposable Protective Mask
K201624 · FXX
Spintech, LLC
General Hospital · 276d
Cleared Mar 18, 2021
Straumann Immediate Temporary Abutments
K201681 · NHA
Institut Straumann AG
Dental · 269d
Cleared Mar 18, 2021
Y207 Electric Wheelchair
K202482 · ITI
Jiangsu Intco Medical Products Co., Ltd.
Physical Medicine · 202d
Cleared Mar 18, 2021
s-Clean SQ-SL Implant System Mini
K202773 · DZE
Dentis Co., Ltd.
Dental · 178d
Cleared Mar 18, 2021
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
K202937 · JFB
Ceragem Co., Ltd.
Physical Medicine · 169d