9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENZYMUN TEST(R) TBK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756732031·GEN SURG UNIV PACK
BICARBONATE; SYSTEM PACK REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MONO-CUBE(TM)
FDA 510(k)
FDA Class 2
·Immunology
KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·June 11, 2014
AMPLATZER® SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·November 11, 2010
KARL STORZ
FDA Adverse Event
Other
·KARL STORZ GMBH & CO. KG·Product code EZO·November 22, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024