9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ONE/CIRC (CIRCUMCISION CLAMP)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
M4-Left 19mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199003700·
SYMMETRIC TOTAL KNEE AGUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
FDA 510(k)
FDA Class 2
·Microbiology
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 27, 2014
VITROS 5,1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·November 16, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 7, 2013
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·July 24, 2024
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
FDA Recall
Open, Classified
·Qiagen Sciences LLC·Product code JJH·June 3, 2024