10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NewTom 7G
FDA 510(k)
FDA Class 2
·Radiology
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994503404·TRASP 5220664 STAND ALONE 16X14 X 6MM
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STERISHARP 3-GALLON RSDC, MODEL RSDC3G
FDA 510(k)
FDA Class 2
·General Hospital
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·April 10, 2022
INDEFLATOR
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAV·November 3, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024