12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PediFlex Flexible Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517631961·CoRoent Ant TLIF Ti, 15x11x36mm 12°
HC Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
FDA 510(k)
FDA Class 2
·Orthopedic
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 10, 2022
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 9, 2011
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 5, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2013
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 9, 2022
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024