21 results · 23ms · Sources: EU EUDAMED, 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