7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAT 12-ORTHOPEDIC & REHAB DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WATER W/TWEEN 80
FDA 510(k)
FDA Class 1
·Microbiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 2, 2014
PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·November 8, 2012
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·June 15, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022