11 results
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24ms
·
Sources: EU EUDAMED, US FDA
ACCU-FLO* UNITIZED SHUNT
FDA 510(k)
FDA Class 2
·Neurology
VuePoint
FDA UDI
Nuvasive, Inc.·00887517178244·VuePoint Rod, 3.5x120mm
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515230422·Ronis Pick, str, 6"
KOAGULAB 60-S COAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 9, 2013
EON 16-CHANNEL IPG
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
VIDAS® BRAHMS PROCALCITONIN
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code NTM·February 7, 2019
MENTOR MEMORYSHAPE BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 16, 2022
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013