17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Brigade
FDA UDI
Nuvasive, Inc.·00887517967312·Brigade Lateral, 9x38x28mm 15°
Emission Computed Tomography System
FDA 510(k)
FDA Class 2
·Radiology
EZLASE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCHRON CREATINE KINASE REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code CGS·June 17, 2011
CADD LEGACY PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·April 11, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 23, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 22, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 9, 2011
DISPENSOR, CEMENT
FDA Adverse Event
Injury
·SYNTHES USA·Product code KIH·August 6, 2014
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 29, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 24, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024