7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
AMRESCO CALCIUM REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
Impact PEEK Union Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010
SUPERMULTI VAC 50
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·November 14, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014