10,000 results
·
48ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MY LAB BOX HSV 2 TEST KIT
FDA Adverse Event
Malfunction
·UNK·Product code OQO·April 19, 2024
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK
FDA Adverse Event
Malfunction
·FOCUS DIAGNOSTICS·Product code OQO·March 6, 2016
HSV 2 VAGINAL PCR SWAB
FDA Adverse Event
Malfunction
·UNK·Product code OQO·February 7, 2024
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK
FDA Adverse Event
Malfunction
·FOCUS DIAGNOSTICS·Product code OQO·March 10, 2016
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK
FDA Adverse Event
Malfunction
·FOCUS DIAGNOSTICS·Product code OQO·March 10, 2016
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK
FDA Adverse Event
Malfunction
·FOCUS DIAGNOSTICS·Product code OQO·March 6, 2016
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK
FDA Adverse Event
Malfunction
·FOCUS DIAGNOSTICS·Product code OQO·March 10, 2016
HSV-1 & HSV-2
FDA Adverse Event
Malfunction
·UNK·Product code OQO·April 30, 2025
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK
FDA Adverse Event
Malfunction
·FOCUS DIAGNOSTICS·Product code OQO·May 18, 2016
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.
FDA Recall
Terminated
·DiaSorin Molecular LLC·Product code OQO·May 12, 2020
Herpes Simplex Virus Nucleic Acid Amplification Assay
FDA classification
FDA Class 2
·Herpes Simplex Virus Nucleic Acid Amplification Assay
OCO Biomedical
FDA UDI
ASEPTICO, INC.·10817417021118·Implant / Endodontic Dental Systems
OCO Biomedical
FDA UDI
ASEPTICO, INC.·10817417020777·The AEU-1000-OCO Dental Implant Motor System is...
OCO Biomedical
FDA UDI
ASEPTICO, INC.·10817417021125·Implant / Endodontic Dental Systems
Olo
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OCO PREPARATIONS
FDA 510(k)
FDA Class 1
·Dental
Sight OLO
FDA 510(k)
FDA Class 2
·Hematology
Sight OLO
FDA 510(k)
FDA Class 2
·Hematology
OCO DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
OCO DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental