17 results · 26ms · Sources: EU EUDAMED, US FDA

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Powder Free Nitrile Examination Glove, Non-sterile (Blue)

FDA 510(k)
FDA Class 1 ·General Hospital

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676220209000·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676220209070·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676220209150·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694034777·1.6mm Low-Profile, Fast-Flap

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 30, 2024

ASR UNI FEMORAL IMPL SIZE 53

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 15, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·June 16, 2022

TRUE METRIX AIR

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·June 18, 2020

Surpria: Software Version V3.11, V3.22

FDA Enforcement
Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025