7 results
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33ms
·
Sources: EU EUDAMED, US FDA
MAMMOGRAPHIC KVP METER MODEL 232
FDA 510(k)
FDA Class 2
·Radiology
IL HEPARINIZED FLOW DIRECTED THERMAL
FDA 510(k)
FDA Class 2
·Cardiovascular
MONOJECT SAMPLETTE CAPILLARY BLOOD COLL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M SERIES
FDA Adverse Event
Death
·ZOLL MEDICAL CORP.·Product code DSK·June 3, 2014
IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·GUIDANT PUERTO RICO BV·Product code NVZ·October 19, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 14, 2012
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024