Search FDA 510(k) Database

6,572 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
10249–10272 of 174,061
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748 · LZA
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 12, 2023
Garmin ECG App
K221774 · QDA
Garmin International, Inc.
Cardiovascular · 205d
Cleared Jan 12, 2023
NeoGen PSR System
K221873 · GEI
Energist Limited
General & Plastic Surgery · 198d
Cleared Jan 12, 2023
HandX Instrument - Monopolar Spatula
K222011 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 189d
Cleared Jan 12, 2023
PreXion3D Expedition
K222150 · OAS
Prexion Corporation
Radiology · 176d
Cleared Jan 12, 2023
AIBOLIT 3D+
K222458 · LLZ
Aibolit Technologies, LLC
Radiology · 150d
Cleared Jan 12, 2023
Rainbow 360
K222830 · KLE
Kerr Corporation
Dental · 115d
Cleared Jan 12, 2023
MU System
K222976 · NHA
Dentis Co., Ltd.
Dental · 106d
Cleared Jan 12, 2023
MAMMOVISTA B.smart (VB70)
K223363 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Jan 12, 2023
Neuronaute with IceCap 2 & IceCap 2 Small
K223644 · GWQ
Bioserenity
Neurology · 37d
Cleared Jan 12, 2023
NuVasive Modulus-C Interbody System
K223731 · ODP
Nuvasive, Inc.
Orthopedic · 30d
Cleared Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD...
K223782 · EOQ
Ambu A/S
Ear, Nose, Throat · 27d
Cleared Jan 11, 2023
DD Solid Connect® CAD/CAM Abutments
K191111 · NHA
Dental Direkt GmbH
Dental · 1356d
Cleared Jan 11, 2023
Transducer Probe Cover
K221278 · ITX
Hony Medical Co., Ltd.
Radiology · 253d
Cleared Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl...
K222181 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 173d
Cleared Jan 11, 2023
Artix BG
K223000 · QEW
Inari Medical
Cardiovascular · 105d
Cleared Jan 11, 2023
NuVasive Reline System
K223181 · NKB
Nu Vasive, Incorporated
Orthopedic · 92d
Cleared Jan 11, 2023
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
K223295 · FDA
Fujifilm Corporaton
Gastroenterology & Urology · 77d
Cleared Jan 11, 2023
RadianceTx Radionuclide Brachytherapy Source
K223465 · KXK
Radiance Therapeutics, Inc.
Radiology · 55d
Cleared Jan 11, 2023
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
K223719 · KWQ
Aegis Spine, Inc.
Orthopedic · 30d
Cleared Jan 11, 2023
Alpha Control Liner System (ACLS)
K223738 · GXY
Coapt
Neurology · 28d
Cleared Jan 11, 2023
INFINITY OCT System
K223764 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · QBJ
Dexcom, Inc.
Chemistry · 12d
Cleared Jan 10, 2023
CoCr Head
K211047 · LPH
Zimmer GmbH
Orthopedic · 642d