10 results
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19ms
·
Sources: EU EUDAMED, US FDA
LKB-BROMMA 2218 HISTORANGE MICROTOME
FDA 510(k)
FDA Class 1
·Pathology
AURADONICS
FDA UDI
AURADONICS INC.·00810033837241·LATEX ELASTICS 1/4" 3.5 oz. - AMBER, 100 bags o...
DXTEND SCREW LOCK D4.5X36MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·December 16, 2025
CHURCHILL MEDICAL SYSTEMS STOPCOCK
FDA 510(k)
FDA Class 2
·General Hospital
BioSign Flu A+B
FDA 510(k)
FDA Class 2
·Microbiology
ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code GBO·August 13, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
SELOX SR 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 18, 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