12 results
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18ms
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Sources: EU EUDAMED, US FDA
BACTIGEN(R) N. MENINGITIDIS
FDA 510(k)
FDA Class 2
·Microbiology
Cross-Linked PE Insert
FDA UDI
ADLER ORTHO SPA·08050507130191·Cross-Linked PE Insert Flat Diam. 32 Gr. B
TRUELOK EVO
FDA UDI
ORTHOFIX SRL·18052469471807·TRUELOK EVO 2 HOLES POST STERILE
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885004220·dentaform® Band, Tooth 36, Size 4/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885004000·dentaform® Band, Tooth 36, Size 4
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885004180·dentaform® Band, Tooth 36, Size 4/Roth 18
SWELL-RELIEF
FDA 510(k)
FDA Class 2
·Cardiovascular
CRIB CUDDLE - INFANT BED
FDA 510(k)
FDA Class 2
·General Hospital
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·October 20, 2010
UNKNOWN HIP STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 12, 2012
MICROSTAAR® INJECTOR
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code KYB·June 19, 2014
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017