22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORIN MINIHIP FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213015296·microSelectron Transfer Tube for 6F Flexibles (14)
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809282811715·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390868952·
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103645·Hemispherical Shell, No Hole, 46mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166268·Initia T3 Acetabular Hemispherical Shell, No Ho...
AUTOPULSE, MODEL 100
FDA 510(k)
FDA Class 2
·Cardiovascular
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017
ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025
STOCKERT S3 GAS BLENDER
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·September 29, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024
SORIN S3 GAS BLENDER
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015
GMK-REVISION FEMUR REVISION PS SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 19, 2017
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.
FDA Enforcement
Class II
·Ongoing·Medtronic Neurosurgery·July 26, 2023