8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
FDA 510(k)
FDA Class 2
·Microbiology
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
FDA 510(k)
FDA Class 1
·General Hospital
Habib EndoHPB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE·Product code MKJ·May 6, 2014
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·December 19, 2012
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 22, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020