10,000 results · 48ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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