9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MEDICOTEST ECG ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
UTB BLUE POWDER FREE NITRILE
FDA 510(k)
FDA Class 1
·General Hospital
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 23, 2012
SMARTSITE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPB·January 15, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code CBI·August 25, 2010
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023