9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTIS icono (VE30A)
FDA 510(k)
FDA Class 2
·Radiology
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365118647·
VIDAS TROPONIN I (TNI), MODEL 30 445
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ventricular Catheter
FDA 510(k)
FDA Class 2
·Neurology
TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/LONG-STERILE
FDA Adverse Event
Death
·RTI SURGICAL·Product code JDQ·September 17, 2020
MAXPLUS CLEAR NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·October 15, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 21, 2011
LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 17, 2013
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021