87 results · 21ms · Sources: EU EUDAMED, US FDA

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iNtuition-Structural Heart Module

FDA 510(k)
FDA Class 2 ·Radiology

Audina

FDA UDI
Bernafon AG·05711584086599·CAPTO 5 MNR, 2.4G NFM PB MSIL/MAC AUDIN

VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

K-Y BRAND LONG LASTING VAGINAL MOISTURIZER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

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·January 7, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

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

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

URISYS 2400

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JIL·October 1, 2008

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 26, 2013

EON RECHARGEABLE IPG, 16-CHANNEL

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 20, 2011

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 9, 2026