9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MOZAIK BONE REGENERATION MATRIX - PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
MOZAIK
FDA Adverse Event
Injury
·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021
Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·June 20, 2012
ELECSYS CA 15-3 CALCHECK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HNC-127 NEUROVASCULAR ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
REDUCTION FORCEPS W/SERRATED JAW-MEDIUM HANDLE-SOFT RATCHET
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·April 16, 2013
TERUMO CDI 100 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTY·April 12, 2011
MCONV PN SEC MACRO OL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·June 18, 2008
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015