7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
QUANTA LITE(TM) IGA ACA
FDA 510(k)
FDA Class 2
·Immunology
DIODENT DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
inspired VHB20 Heated Humidifier
FDA 510(k)
FDA Class 2
·Anesthesiology
REVEAL DX
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DSI·December 13, 2010
RESOLVE NON-LOCKING DRAINAGE CATHETER
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQY·January 11, 2013
5.5MM TI HARD ROD 200MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·July 9, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015