9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ARGOSTAT
FDA 510(k)
FDA Class 1
·Radiology
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
FDA 510(k)
FDA Class 1
·Ophthalmic
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 31, 2022
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·August 9, 2010
SYRINGE S2 5ML 22GA 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 10, 2019
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015