8 results
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24ms
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Sources: EU EUDAMED, US FDA
VIRGO IPA FOR DETECTION OF GENTAMICIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BI-MENTUM dual mobility system
FDA 510(k)
FDA Class 2
·Orthopedic
HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 31, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·August 23, 2010
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
FDA Recall
Terminated
·Abbott Electrophysiology·Product code MTD·August 12, 2015
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024