16 results · 22ms · Sources: EU EUDAMED, US FDA

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MAGNETIC CONCERTO

FDA 510(k)
FDA Class 2 ·Radiology

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159019025·Jacobson Micro Needle Holder Round Handle

SELF ADHERING NAVIGUS GUIDE

FDA 510(k)
FDA Class 2 ·Neurology

E3 MICROPROB SERIES OF LASERS AND ACCESSORIES

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

BD

FDA Adverse Event
Injury ·BECTON, DICKINSON AND CO.·Product code FMI·October 12, 2007

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 6, 2025

ASSURE WEARABLE CARDIOVERTER DEFIBRILLAT

FDA Adverse Event
Malfunction ·KESTRA MEDICAL TECHNOLOGIES, INC.·Product code MVK·November 26, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code MDS·February 18, 2011

G2 FILTER SYSTEM - FEMORAL

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·February 22, 2008

EPIDURAL CATHETERIZATION KIT

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code BSO·April 14, 2022

EPIDURAL CATHETERIZATION KIT NRFIT

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL LLC·Product code CAZ·May 23, 2022

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024