9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRN ADAPTER
FDA 510(k)
FDA Class 2
·General Hospital
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088743·Paddle Distractor, Long, 14mm
SURE-CUT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
JACE MODEL 100 KNEE CPM DEVICE
FDA 510(k)
FDA Class 1
·Physical Medicine
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2016
RENEGADE FIBER BRAIDED MICROCATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KRA·December 20, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 14, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 21, 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