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

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Electric Nasal Aspirator (BC026, BC025, BC023)

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

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197167055·Love retractor 19cm, angled, 90

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

FDA 510(k)
FDA Class 2 ·Neurology

MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

TELEGRAPH®

FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489506970·

VITROS 5,1 FS CHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·November 14, 2014

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 26, 2008

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 12, 2011

ACCOLADE DR SL MRI (Model L311)

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

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013