10 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VANTAGE ELAN
FDA 510(k)
FDA Class 2
·Radiology
UniTip Catheter
FDA UDI
Unisensor AG·07640172973868·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973783·
MULTIFIT TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
FDA 510(k)
FDA Class 2
·Orthopedic
AMISTEM H, HA COATED STEM SIZE 4 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 17, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011
SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020