15 results · 21ms · Sources: EU EUDAMED, 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