16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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