16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMBIBE NEEDLE
FDA 510(k)
FDA Class 1
·Orthopedic
XLIF Decade Plate
FDA UDI
Nuvasive, Inc.·00887517317070·XLIF Decade Plate, 4-Hole Size 14
AGXO
FDA UDI
Oticon A/S·05707131269874·H330, DESIGNRITE 10 WL CNB AGXO
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180521243·Low Profile Trial Drill Guide Drill -14mm
PROTOE ENDOSORB SMALL HAMMER TOE PIN
FDA 510(k)
FDA Class 2
·Orthopedic
QLAB 8.1 QUANTIFICATION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 20, 2015
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 14, 2015
MEDTRONIC MINIMED 670G
FDA Adverse Event
Injury
·MEDTRONIC·Product code CGA·December 6, 2016
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 23, 2015
IDENTITY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC CRMD·Product code DXY·January 13, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 31, 2013
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·June 16, 2011
MICROFRANCE® INSTRUMENT
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·August 4, 2014
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 3, 2014