10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ALBUMIN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sterngold Implant System Guided Drill 4.05mm x 12mm.
FDA UDI
STERNGOLD DENTAL LLC·00841549118807·Used to generate the bore into the bone into wh...
NOVAPATH MICROPLATE READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·September 21, 2021
OCTRODE TRIAL LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 10, 2015
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·May 29, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
ANATOMIC SHOULDER PROSTHESIS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·May 12, 2026
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
FDA Enforcement
Class II
·Terminated·CareFusion 303, Inc.·December 30, 2015