11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cove Strip
FDA 510(k)
FDA Class 2
·Orthopedic
Bernafon
FDA UDI
Sbo Hearing A/S·05714464030910·AO9 MNR T MAC ALIGO 9
ADSON CEREBELLAR RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026704·ADSON CEREBELLAR RETRACTOR ANGLED ARMS SHARP TIPS
Otoplan
FDA 510(k)
FDA Class 2
·Radiology
FUTURABOND UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·November 6, 2014
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·November 7, 2008
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013
BD DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 6, 2018
DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 20, 2018
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025