15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Disposable Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
X TWIN SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM
FDA Adverse Event
Injury
·LDR MEDICAL·Product code OVD·November 13, 2019
FORTIFY ASSURA DR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·June 21, 2011
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
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Injury
·CONMED UTICA·Product code GEI·May 18, 2023
ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·May 13, 2023
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·May 25, 2023
1823260-2016-02004
FDA Adverse Event
Malfunction
·December 19, 2016
GMK-PRIMARY FEMUR CEMENTED SIZE 5 NARROW / RIGHT STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 7, 2016
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021