67 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ascendant TM Cervical Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502406·SCREW 2150130 SCREW 30MM
Teleflex
FDA UDI
Provision·B504LG41501300·
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704711816·Rusch Polaris FO Blade, Mac 3
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704629692·Rusch Polaris FO Blade, Mac 3
Signex
FDA UDI
OSTEONIC CO.,Ltd.·08809595970956·
TiLock
FDA UDI
Genesys Orthopedics Systems LLC·M719G1501300·Pre-Bent Rod
KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWQ·November 10, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWQ·November 10, 2017
RUSCH POLARIS FO BLADE MAC 3
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCW·July 31, 2024
Widex
FDA UDI
Widex A/S·05706069558333·Widex UNIQUE U-XP (Clay brown ) 330, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069558340·Widex UNIQUE U-XP (Dark brown ) 330, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069886900·WIDEX MOMENT M-XP (Clay brown ) 330, Telecoil
Widex
FDA UDI
Widex A/S·05706069886917·WIDEX MOMENT M-XP (Dark brown ) 330, Telecoil
Widex
FDA UDI
Widex A/S·05706069558326·Widex UNIQUE U-XP (Light beige ) 330, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069886894·WIDEX MOMENT M-XP (Light beige ) 330, Telecoil
INTELLIVUE MULTI-MEASUREMENT MODULE X3
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025