23 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756611770·Shoulder Immobilizer
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040358·PrimaLIF Dual Sided Mallet
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481118197·LOCATOR R-Tx Abutment For 3.3mm Premium, Sweden...
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046766·
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
FDA 510(k)
FDA Class 2
·Radiology
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT
FDA 510(k)
FDA Class 2
·Dental
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD¿ QUINCKE SPINAL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·August 8, 2022
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·April 14, 2024
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·April 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
BD PHASEAL¿ INJECTOR LUER LOCK N35
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·January 3, 2023
BD® QUINCKE SPINAL NEEDLES 27G
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·January 25, 2023
BD® QUINCKE SPINAL NEEDLES 27GA 3.50 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·May 24, 2022
BD PLASTIPAK¿ 3ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 17, 2022
BD PHASEAL¿ INJECTOR LUER LOCK N35
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·February 27, 2023
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F
FDA Recall
Terminated
·Medtronic Neurosurgery·Product code GWG·July 5, 2005