11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPUS IC PROFESSIONAL PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTA PRESSOVER
FDA 510(k)
FDA Class 2
·Dental
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·February 3, 2017
ETS LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 1, 2014
HUDSON DISPOSABLE ADULT RESUSCITATION BAG
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BTM·May 23, 2013
SAPHIR 3
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·June 16, 2011
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·March 10, 2017
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017