15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70604161·Mini-Mono-Brackets Ricketts 'N' .018" 20 Brackets
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306813771·Graefe Tissue Forceps, 1x2, Curved, 7cm
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707004118·Rumor .022 LR5 -22T 0A 0O
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707004125·Rumor .022 LR5 HK -22T 0A 0O
HERACERAM 75
FDA 510(k)
FDA Class 2
·Dental
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN NOTTINGHAM SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBF·May 17, 2017
COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016
PURACOL PLUS COLLAGEN WOUND DRESSING
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code KGN·April 16, 2026
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 16, 2013
UNKNOWN GIA DST PRODUCT
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·June 12, 2008
TECNIS CL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·April 16, 2011
SATELLITE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021