73 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPLEX 2200 EBV IGM KIT
FDA 510(k)
FDA Class 1
·Microbiology
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961230210·Bone graft holding and drilling forceps
20cm, ...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 21, 2019
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 21, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 26, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 8, 2014
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 14, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2016
GMK-REVISION FEMUR REVISION PS SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019
GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2018
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2018
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2024