72 results · 29ms · Sources: EU EUDAMED, US FDA

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COMPRESSYN BAND

FDA 510(k)
FDA Class 2 ·Orthopedic

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925016354·FARRIOR 45 DEG ANGLE PICK RIGHT

N/A

FDA UDI
Tyber Medical, LLC·M695M1304310·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450333006·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450332306·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450322512·

COREN TOTAL HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

IMMERSION HYDROBATH

FDA Adverse Event
Malfunction ·INVACARE CLEVELAND STREET·Product code ILJ·May 24, 2013

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 30, 2014

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·June 16, 2011

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

FDA Enforcement
Class II ·Terminated·Ecolab Inc·February 19, 2014

INSPIRE 6F

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

BD VACUTAINER® CTAD BLOOD COLLECTION TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 26, 2022

RESERVOIR INSPIRE 8

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

INSPIRE HARD VENOUS RESERVOIR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023

INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016

INSPIRE HVR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022