9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Diode Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURETEMP PLUS
FDA 510(k)
FDA Class 2
·General Hospital
RETRACTION PASTE
FDA 510(k)
FDA Unclassified
·Unknown
*
FDA Adverse Event
BIOMET INC·Product code JDI·April 13, 2012
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 16, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025