13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sparrow Therapy System
FDA 510(k)
FDA Class 2
·Neurology
CODMAN
FDA UDI
Cerenovus, Inc.·10886704002581·CODMAN Slimline Temporary Aneurysm Clip No 7 Bl...
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MASTERSCREEN IOS
FDA 510(k)
FDA Class 2
·Anesthesiology
Widex
FDA UDI
Widex A/S·05706069728392·Widex EVOKE E-FS (Deep Blue S-440 ) Telecoil, R...
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
PARADYM 2
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code LWO·July 30, 2018
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021