8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPTURE-R READY-SCREEN (4)
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·November 13, 2006
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2013
VICTORY XL SR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 29, 2011
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