10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Sklar®
FDA UDI
SKLAR CORPORATION·10649111220753·GUYON SOUND W/THREAD 11FR
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177669·11mm, 3-Hole Threaded Anterior Plate
ECP HEALTH SYSTEM, MODEL 2005
FDA 510(k)
FDA Class 2
·Cardiovascular
V20 system
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
VENTAK PRIZM 2
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code LWS·October 4, 2010
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 26, 2012
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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