8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100
FDA 510(k)
FDA Class 2
·Radiology
GC Initial™
FDA UDI
Gc America Inc.·J0228746391·GC Initial™ Ti Shoulder Opaq. SO-39, 50g
BIOMECCA CENTRAL CS1
FDA 510(k)
FDA Class 2
·Cardiovascular
REUSABLE SURGICAL KERATOSCOPE
FDA 510(k)
FDA Class 1
·Ophthalmic
LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·PRODUCTOS PARA EL CUIDAD DE LA SALUD·Product code EZL·April 24, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·December 15, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024