21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CATHETER CONNECTIONS' DUALCAP SOLO
FDA 510(k)
FDA Class 2
·General Hospital
5570 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021928·5570 3L SYR HRI TOURQ NDD OUTL
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105346·PS3 Screw 8.5mm x 40mm
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMUNO-TROL LOW CELLS
FDA 510(k)
FDA Class 2
·Hematology
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 4, 2014
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 2, 2013
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 19, 2021
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·March 13, 2012
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·March 13, 2012
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 10, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 14, 2015
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 3, 2013
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 1, 2014
ARCOMXL RINGLOC 10 DEGREE 28MM SIZE 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·May 15, 2013
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 28, 2015
R3 XLPE INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 12, 2014
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025