13 results
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21ms
·
Sources: EU EUDAMED, US FDA
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
FDA 510(k)
FDA Class 1
·Microbiology
Cross-Linked PE Insert
FDA UDI
ADLER ORTHO SPA·08050507130207·Cross-Linked PE Insert Flat Diam. 32 Gr. C
TRUELOK EVO
FDA UDI
ORTHOFIX SRL·18052469471821·TRUELOK EVO 4 HOLES POST STERILE
AMC
FDA UDI
Advantage Medical Electronics, LLC·00849593016124·5 Lead ECG Cable GE to Phillips Intellivue, 12"
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885006220·dentaform® Band, Tooth 36, Size 6/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885006000·dentaform® Band, Tooth 36, Size 6
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885006180·dentaform® Band, Tooth 36, Size 6/Roth 18
CANTROL CK/MB CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SUN MEDICAL LAMINARIA CERVICAL DILATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
1/8" PEG DRILL
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·June 19, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 20, 2010
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·December 19, 2012
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