21 results · 28ms · Sources: EU EUDAMED, 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