9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
FDA 510(k)
FDA Class 1
·Anesthesiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490906692·INSTRUMENT 8951804 DBL BARRL OTR SLV 18M
KHEIRON® Spinal Fixation System, including patient specific K-ROD
FDA 510(k)
FDA Class 2
·Orthopedic
ABL80 FLEX ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3.0MM CANNULATED SCREW LONG THREAD/34MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·February 19, 2013
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 6, 2011
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024