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

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ATEC Cervical Spacer System

FDA 510(k)
FDA Class 2 ·Orthopedic

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741814350·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674181435060·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1814350·18mm H x 14mm W x 35mm L x 0 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L181435120·18mm H x 14mm W x 16mm L XLIF Trial 12 degree L...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X181435120·18mm H x 14mm W x 35mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X18143580·18mm H x 14mm W x 35mm L x 8 degrees XLIF

DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

IMIX PANORAD AND SOMARAD

FDA 510(k)
FDA Class 2 ·Radiology

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 1, 2023

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 14, 2021

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2021

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

ACCURUS 400VS

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 6, 2011

HERCULES

FDA Adverse Event
Malfunction ·COOK MEDICAL·Product code KNQ·June 12, 2013

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 3, 2021

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 8, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 4, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 7, 2021