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

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ExacTrac Dynamic

FDA 510(k)
FDA Class 2 ·Radiology

EarQ

FDA UDI
Sbo Hearing A/S·05714464006496·F500 FW 1.0.0

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824555·Walther Female Dilator-Catheters 13cm, 38Fr

STEALTHSTATION WITH FLUOROMERGE SOFTWARE

FDA 510(k)
FDA Class 2 ·Neurology

ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA

FDA 510(k)
FDA Class 2 ·Dental

FISHER & PAYKEL HEALTHCARE

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 30, 2024

UNKNOWN DEPUY TIBIAL INSERT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·November 3, 2008

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 23, 2011

FORTIFY ASSURA VR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

FISHER & PAYKEL HEALTHCARE

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

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

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

FISHER & PAYKEL HEALTHCARE

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

MSS - HUMERAL REVERSE LINERS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026

FISHER & PAYKEL HEALTHCARE

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

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025