10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flexible HD Cysto-Urethroscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
FDA 510(k)
FDA Class 2
·Cardiovascular
GRINDGUARD
FDA 510(k)
FDA Unclassified
·Unknown
C&S PRESERVATIVE TUBE AND URINE TRANSFER STRAW
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JSM·December 6, 2017
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 8, 2011
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 21, 2013
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·October 17, 2014
BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BD CARIBE, LTD·Product code MDB·June 24, 2023
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 13, 2017
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024