15 results · 22ms · Sources: EU EUDAMED, US FDA

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FDR AQRO (DR-XD 1000)

FDA 510(k)
FDA Class 2 ·Radiology

EXPRESS SERIES

FDA 510(k)
FDA Class 2 ·Anesthesiology

LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,

FDA 510(k)
FDA Class 2 ·Orthopedic

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

MP70 INTELLIVUE PATIENT MONITOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSI·May 23, 2013

MP30 INTELLIVUE PATIENT MONITOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 22, 2011

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

POD PACKING COIL

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·November 8, 2017

HEMOSIL ACUSTAR HIT-IGG(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

HEMOSIL ACUSTAR HIT-IGG(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

POD PACKING COIL

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code HCG·October 23, 2017

HEMOSIL ACUSTAR HIT-IGG(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·June 6, 2025

HEMOSIL ACUSTAR HIT-IGG (PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·April 8, 2025

HEMOSIL ACUSTAR HIT-IGG(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017