47 results
·
25ms
·
Sources: EU EUDAMED, US FDA
HILLA DIGITAL TRANSFERS
FDA 510(k)
FDA Class 2
·Dental
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304213050·
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003600·76 V2 ASSY LARGE 22ID NO HG
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045593·Wedge Distractor, 10mm
SPIRO PD
FDA 510(k)
FDA Class 2
·Anesthesiology
KPS-I, THE KIDNEY PERFUSION SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 5, 2019
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 10, 2013
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 24, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 24, 2011
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 6, 2019
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·April 28, 2014
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 5, 2019
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026