21 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITECT 2nd Generation Testosterone
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Life Instruments
FDA UDI
Life Instrument Corporation·M930715215510·Revision Curette 21.5" #5
MR RADIATION ONCOLOGY OPTIONS
FDA 510(k)
FDA Class 2
·Radiology
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 19, 2019
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·May 12, 2021
LUMAX 540 DR-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code MRM·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 7, 2011
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code KRO·December 1, 2021
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 16, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWY·October 16, 2019
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 16, 2019
AS ENDURO FEMORAL COMPONENT CEMENTED F1R
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·September 1, 2021
ENDURO MENISCAL COMPONENT F3 10MM
FDA Adverse Event
Injury
·AESCULAP AG·Product code KRO·August 4, 2021
COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
FDA Adverse Event
Injury
·AESCULAP AG·Product code HRZ·August 10, 2022
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 6, 2008
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014