15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304425781·
Oticon
FDA UDI
Oticon A/S·05707131271594·RIA, KIT 10 WL OMNI 85 PB BE
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613042752·Myringotomy Knife Handle (Chuck Style), Overall...
METAFLEXCOIL
FDA 510(k)
FDA Class 2
·Radiology
MINIMESH POLYPROPYLENE MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034965·Corpectomy, 14Dx16Wx32H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929035139·Corpectomy, 14Dx16Wx32H 6°
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
TUBE, FEEDING, CORTRAK
FDA Adverse Event
Malfunction
·CORPAK MEDSYSTEMS·Product code KNT·June 15, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·February 10, 2020
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018