9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OPUS FSH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
AXSYM TOXO IGG REAGENT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LGD·December 1, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013