8 results
·
33ms
·
Sources: EU EUDAMED, US FDA
SEAL RING FOR NASAL CPAP
FDA 510(k)
FDA Class 1
·Anesthesiology
Bosworth Light Liner
FDA UDI
Harry J Bosworth Company·H66809214991·Hard Reline Mat. P&L Single Dose
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
NEXGEN GSF CR-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·January 9, 2013
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·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