23 results · 23ms · Sources: EU EUDAMED, US FDA

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Recovery Pump, 737R (RPX)

FDA 510(k)
FDA Class 2 ·Physical Medicine

Oticon

FDA UDI
Oticon A/S·05707131338969·SIYA 2, BTE 13 PP 2.4G 105 C063

TANDEMHEART PUMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

SIGNAL

FDA 510(k)
FDA Class 2 ·Cardiovascular

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

PERICARDIOCENTESIS KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code GBX·June 21, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 16, 2014

CAPIOX RX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·May 26, 2023

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

CAPIOX RX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2018

CAPIOX RX OXYGENATOR

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·January 31, 2024