9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BLOOD MONITOR PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral
FDA UDI
Merz Dental GmbH·D7091970591·anteriors; shade A2 light; mould BIM
Altomed Malhotra Platinum Segments
FDA 510(k)
FDA Class 2
·Ophthalmic
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
FDA 510(k)
FDA Class 2
·Dental
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·February 20, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 25, 2011
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 31, 2014
CERAMIC ELECTRODE TIP L-HK F/GK372R
FDA Adverse Event
Injury
·AESCULAP AG·Product code GEI·July 5, 2019
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016