13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IDENTI LOOPS DEGANIA SILICONE
FDA 510(k)
FDA Class 2
·Cardiovascular
Couture Essence
FDA UDI
Carolon Company·00078301981045·
Couture Essence
FDA UDI
Carolon Company·00078301920143·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·February 23, 2015
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·September 2, 2014
Knee+
FDA 510(k)
FDA Class 2
·Neurology
VISIONSEARCH 1
FDA 510(k)
FDA Class 2
·Neurology
LUXSTAR UNIT-MOUNT LIGHT
FDA Adverse Event
Injury
·DENTAL EQUIPMENT LLC (DBA NEWBERG MANUFACTURING)·Product code EAZ·December 7, 2010
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 17, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEATHCARE CORPORATION·Product code FKX·July 8, 2014
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021
Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.
FDA Recall
Terminated
·Spinal Elements, Inc·Product code NKB·April 9, 2015