9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
FilmArray RP2/RP2plus Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
High Density 144 Sublative iD (20 Pulse), 10-Pk
FDA UDI
SYNERON MEDICAL LTD·37290109952209·High Density 144 Sublative iD (20 Pulse), 10-Pk
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100844·MCNEILL GLOBAL FIXATION RING SMALL
RESUSCITATION TIMER, MODEL L770-CPR
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECSYS ANTI-TPO CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020