15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DANA REUSABLE TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
Oticon
FDA UDI
Oticon A/S·05707131260239·RIA, BTE 13 WL 100 DBL
EPRICORD
FDA 510(k)
FDA Class 2
·Dental
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
FDA 510(k)
FDA Class 2
·Ophthalmic
ACTIV.A.C.¿ THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018
BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·September 6, 2024
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·October 1, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·May 11, 2011
MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 25, 2021
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 19, 2019
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