11 results
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26ms
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Sources: EU EUDAMED, US FDA
SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295246411·SIGMA TC3 RP INSERT TRIAL SIZE 4 20mm
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
FDA 510(k)
FDA Class 2
·Neurology
D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEPTH ELECTRODE
FDA Adverse Event
Malfunction
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021
SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
FDA Adverse Event
Injury
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2014
PUMP IN STYLE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·December 17, 2010
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·February 15, 2013
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·February 6, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024