17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ti-Largo Cervical Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232314·
ELFCARE DEVICE, MODELS 314A THROUGH 314G
FDA 510(k)
FDA Class 2
·Neurology
CALIBER SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·February 9, 2016
PRECISION XTRA
FDA Adverse Event
Injury
·Product code NBW·December 31, 2013
CATH PKGD: WEDGE 6 FR 110 CM
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC.·Product code DYG·October 27, 2014
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·August 12, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 12, 2013
STEALTHSTATION S7
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·July 17, 2020
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 29, 2019
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 29, 2019
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 29, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWY·October 29, 2019
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025