10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NORDICLAB FERRITIN IRMA TEST
FDA 510(k)
FDA Class 2
·Immunology
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750001750·VITROS Chemistry Products BENZ Reagent
Polishers
FDA UDI
DFS - DIAMON GmbH·04057176147363·UPORAL D cup, pu: 2 pcs
MODIFICATION TO FETCH ASPIRATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 23, 2012
ASR 300 SPIKED CUP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·May 28, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012