17 results · 23ms · Sources: EU EUDAMED, US FDA

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EchoMark, EchoMark LP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ZenFlex

FDA UDI
Kerr Corporation·00195062030055·Rotary Files

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·July 9, 2018

VIDAS® CMV IGM

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·July 6, 2018

SHENGKUN CHEMICAL

FDA 510(k)
FDA Class 1 ·General Hospital

FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01

FDA 510(k)
FDA Class 2 ·Cardiovascular

COVIDIEN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

COVIDIEN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

SYRINGE, LUER LOCK, STERILE, 10ML

FDA Adverse Event
Malfunction ·MEDLINE INDUSTRIES, LP·Product code FMF·March 28, 2024

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·October 15, 2014

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 20, 2013

LEGEND FOOTED ATTACHMENT

FDA Adverse Event
Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·July 27, 2011

OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

ROSA Brain 3.0 Application-Brain

FDA Enforcement
Class II ·Terminated·MEDTECH SAS·February 19, 2020

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020