9 results
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35ms
·
Sources: EU EUDAMED, US FDA
TSH RIA
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LONESTAR
FDA UDI
Orthofix US LLC·18257200090402·DIA 4.0MM X 10MM RESCUE BONE SCREW - SELF TAPPING
Ophthalmic Spoon
FDA UDI
KATENA PRODUCTS, INC.·00841668103425·LOOP FOR NUCLEUS DIVIDER PACK OF 3
OLYMPUS URINE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NORDICBRAINEX
FDA 510(k)
FDA Class 2
·Radiology
INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code OAD·May 27, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2012
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 10, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024