49 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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