14 results
·
30ms
·
Sources: EU EUDAMED, US FDA
OsteoPlan System
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584115282·CO7 MNR, 2.4G NFM SABE/MSIL CAPTO 7 GPL
Sklar®
FDA UDI
SKLAR CORPORATION·10649111353581·MAYO HEGAR NH BROAD 7" TC
Unity
FDA UDI
DIOMEDICAL CO.,LTD.·08800039821704·SIJ Lag ScrewOD12.5xL70
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 18, 2018
CENTRICITY CARDIO IMAGING
FDA 510(k)
FDA Class 2
·Radiology
Insulin Syringe, Insulin Syringe with Safety Retractable
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
RAPIDLOK MENISCAL FASTENER
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·October 24, 2008
PUMP IN STYLE BREAST PUMP
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·August 11, 2011
VAMP JR. COMBO KIT
FDA Adverse Event
Product code KRA·July 2, 2013
DEKA LIPOAI
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021