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

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ZEOBI

FDA 510(k)
FDA Class 2 ·Physical Medicine

NEWFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACCULEAF

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 15, 2023

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·August 12, 2025

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 26, 2014

LOCKING RECONSTRUCTION PLATE 6X23 HOLES 44MM X 214MM/RIGHT

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code JEY·June 6, 2011

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 29, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 10, 2026

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·January 22, 2026

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·April 17, 2026

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·December 27, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code QAV·September 16, 2025