12 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088668·Paddle Distractor, 18mm
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVOLVE RADIAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·July 16, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 21, 2012
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·December 20, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
ECHOTIP ULTRA ULTRASOUND ASPIRATION NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·November 19, 2010
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·July 29, 2014
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·September 17, 2014
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