92 results · 22ms · Sources: EU EUDAMED, US FDA

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KinematX Total Wrist Arthroplasty System

FDA 510(k)
FDA Class 2 ·Orthopedic

Phasix

FDA UDI
Davol Inc.·00801741107597·Phasix Mesh, 6" x 10" (15 cm x 25 cm), Rectangle

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465036·CDH 7191525 HA COATED 5.5X25

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK

PERIMETER INTERBODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

PIONEER SPINOUS PROCESS FUSION PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

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

INTRALASE FS2

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·June 26, 2013

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 27, 2011

SOFTCLIX LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 26, 2008

ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

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