18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PathLoc-SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Midmark
FDA UDI
MIDMARK CORPORATION·00841709107160·Track/Trolley Assembly used on the Track Mounte...
TYRX ANTIMICROBIAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMO SCIENTIFIC MAS R DOA TOTAL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
FORMATK MAGMA PLATFORM LASER
FDA Adverse Event
Injury
·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 28, 2024
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017
FORMATK MAGMA PLATFORM
FDA Adverse Event
Malfunction
·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 17, 2017
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 7, 2019
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 15, 2024
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023