8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ISOKINETIC SYSTEM, TESTING AND EVALUATION
FDA 510(k)
FDA Class 2
·Physical Medicine
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109922·NEVYAS-WALLACE LIBORATING CORTEX CAN
DIAGNOSTIC REAGENT PET-RPLA
FDA 510(k)
FDA Class 1
·Microbiology
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
FDA 510(k)
FDA Class 2
·Orthopedic
DURALOC CONST LINER 54X32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code KWY·June 16, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 19, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 17, 2012
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021