8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
VERSION 3 OPERATING SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515243798·Weil Blakesley Fcps, str, sz 3, 6.0mm
MICROAIRE MODEL 2600
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IMS-200
FDA 510(k)
FDA Class 2
·Hematology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·January 30, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 3, 2014
LIGASURE V SEALER/DIVIDER
FDA Adverse Event
Malfunction
·COVIDIEN, LLC (SHANGHAI)·Product code GEI·December 16, 2010
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019