314 results · 21ms · Sources: EU EUDAMED, US FDA

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INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS

FDA 510(k)
FDA Class 2 ·Orthopedic

MOZAIK

FDA Adverse Event
Injury ·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021

Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-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

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496063124·SOCKS FOR YOU BAMBOO MUSIC, SIZE XXL, BLU NAVY,...

CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DURALOC LINER

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS·Product code KWA·April 17, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 12, 2011

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 20, 2008

NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 26, 2018

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

BD PHOENIX¿ NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026

PANEL PHOENIX NMIC-312

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026