17 results · 22ms · Sources: EU EUDAMED, US FDA

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Reprocessed Stryker External Fixation Devices

FDA 510(k)
FDA Class 2 ·Orthopedic

Sklar

FDA UDI
SKLAR CORPORATION·10649111451836·SKLHN METZ SCISS CVD SERR 12 INCHES

Ellis External Mini Fixator

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575229413·fixation pins with thread,thread length 17 mm

LESIONPOINT RF CANNULA

FDA 510(k)
FDA Class 2 ·Neurology

TANDA MAX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

STEM: AMISTEM H HA COATED STD STEM SIZE 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 2, 2019

ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

FDA Adverse Event
Injury ·LDR MEDICAL·Product code OVD·November 13, 2019

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

ATTAIN ABILITY

FDA Adverse Event
Injury ·RICE CREEK MFG·Product code OJX·June 8, 2013

VITALITY

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

AMISTEM H, HA COATED STEM 0 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 2, 2016

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 17, 2019

ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code MAX·April 23, 2019

ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code MAX·January 27, 2023

ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code MAX·May 13, 2023

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023