17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TREFOIL System
FDA 510(k)
FDA Class 2
·Dental
AGC V2 TOTAL KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·05019279383795·
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575316588·Hinge Knee Joint Prosthesis,with anti-luxation ...
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575316571·Hinge Knee Joint Prosthesis,with anti-luxation ...
BODIHEALTH SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BONASIL A+ IMPRESSION MATERIALS
FDA 510(k)
FDA Class 2
·Dental
TARGET DEVICE 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012
UNKNOWN ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 26, 2024
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·July 7, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 4, 2008
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
UNKNOWN TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 26, 2024
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 24, 2024
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023