22 results · 22ms · Sources: EU EUDAMED, 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