8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
FDA 510(k)
FDA Class 2
·Ophthalmic
MOLDED PRODUCTS INC.
FDA registration
MOLDED PRODUCTS INC.·20 products·🇺🇸 United States
IOB DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 29, 2013
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·December 20, 2010
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 14, 2014
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