10 results
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26ms
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Sources: EU EUDAMED, US FDA
BAXTER BAFFLED TEE ADAPTER
FDA 510(k)
FDA Class 1
·Anesthesiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756217903·ST STURDI STRAINER
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES
FDA 510(k)
FDA Class 1
·Hematology
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·July 12, 2023
UNIVERSAL BATTERY CHARGER - 4 BAYS
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code MOQ·June 25, 2014
UNK DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 5, 2010
12X100MM KII CANNULA & SEAL THREADED 12/BOX
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·December 27, 2012
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
FDA Recall
Open, Classified
·DeRoyal Industries Inc·Product code FNY·May 30, 2023
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014