12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AcuNav Diagnostic Ultrasound Catheter 8F,10F
FDA 510(k)
FDA Class 2
·Cardiovascular
Well at Walgreens
FDA UDI
WALGREEN CO.·00049022632820·Plastic Applicator Tampon, Multi pack 36, 18 Re...
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APNEALINK
FDA 510(k)
FDA Class 2
·Anesthesiology
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 20, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 14, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Malfunction
·BIOENTERICS CORPORATION·Product code LTI·September 10, 2008
PROGREAT
FDA Adverse Event
Injury
·Product code DQO·April 30, 2021
PROGREAT
FDA Adverse Event
Malfunction
·Product code DQO·May 28, 2021
TERUMO PROGREAT CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 21, 2015
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
FDA Enforcement
Class II
·Terminated·Brainlab AG·January 21, 2015