16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IRIS 1.0 System
FDA 510(k)
FDA Class 2
·Radiology
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 27, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 25, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·ANGEL KISS LLC.·Product code FTC·February 3, 2021
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·UNK·Product code FTC·January 26, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·UNK·Product code FTC·January 29, 2021
UV PHOTOTHERAPY
FDA Adverse Event
Injury
·ANGEL KISS LLC·Product code FTC·February 2, 2021
UV PHOTOTHERAPY LAMP
FDA Adverse Event
Injury
·ANGEL KISS LLC.·Product code FTC·February 4, 2021
IN TOUCH EU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 21, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 28, 2011
ACCU-CHEK COMPACT PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·July 22, 2008
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021