10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ALCON OPERATING MICROSCOPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122819·K-WIRE - DOUBLE TROCAR 0.6mm DIA x 100mm
Liofilchem MTS (MIC Test Strip)
FDA UDI
LIOFILCHEM SRL·08055182872176·
GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
FDA 510(k)
FDA Class 2
·Anesthesiology
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
ACT 3 SENSOR
FDA Adverse Event
Malfunction
·LIFEWATCH SERVICES, INC.·Product code DSI·October 20, 2010
ENDURITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·December 7, 2012
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