16 results · 21ms · Sources: EU EUDAMED, 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