34 results · 25ms · Sources: EU EUDAMED, US FDA

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ALIVECOR HEART MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925016620·GOLDMAN SMALL RIGHT ANGLE PICK

N/A

FDA UDI
Tyber Medical, LLC·M695M1304090·

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

STAR TOTAL ANKLE REPLACEMENT

FDA Adverse Event
Injury ·SMALL BONE INNOVATIONS, INC.·Product code NTG·September 18, 2014

STAR TOTAL ANKLE REPLACEMENT

FDA Adverse Event
Injury ·SMALL BONE INNOVATIONS, INC.·Product code NTG·September 2, 2014

INSPIRE 7F M N/S

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 14, 2026

IN TOUCH ZU

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·September 30, 2014

DUAL TRIGGER ROTARY

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 9, 2011

INSPIRE 7F M N/S

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026

HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019

INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017

INSPIRE 6F HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022

INSPIRE 6 HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·February 25, 2022

ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 30, 2013

INSPIRE 6

FDA Adverse Event
Death ·SORIN GROUP ITALIA SRL.·Product code DTZ·July 15, 2024

INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 17, 2018