11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MALLEABLE TIP ENDOSCOPIC APPLICATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMO-STREAM HEMODIALYSIS CATHETER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BORRELIA BURGDORFERI IGG BLOT TEST
FDA 510(k)
FDA Class 2
·Microbiology
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LEH·May 20, 2026
CLEARLINK BURETROL SOLUTION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 13, 2023
PEN NDL 31G 6MM 3B TW 100CT
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 8, 2019
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·May 15, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 14, 2011
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·August 15, 2008
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015