16 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD BBL™ Sensi-Disc™ Gentamicin 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312995·BD BBL™ Sensi-Disc™ Gentamicin 10 µg
LANEX Regular Screens
FDA UDI
CARESTREAM HEALTH, INC.·60889971231291·LANEX Regular SCR 1PR 8x10in NF
ELMED
FDA UDI
ELMED INCORPORATED·00842180161047·PRISM CERVICAL CURETTE 10" ANGLED 90° 4-0, PURPLE
ELECSYS LH CALSET II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANYTHINK PACS WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 0.5ML 30GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·June 24, 2021
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·July 25, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022