8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CATEGORY 17-MICROBIOLOGY DEVICES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
FDA 510(k)
FDA Class 2
·Cardiovascular
SIMPLY SLICK PERSONAL LUBRICATING LOTION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·February 24, 2022
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 30, 2014
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JJE·November 20, 2012
PATIENT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FRK·September 10, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015