8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
KEY-MED FIBRESCOPE DISINFECTION TROLLEY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 4, 2019
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFANT LIMB HOLDER, MODELS 306080 & 306081
FDA 510(k)
FDA Class 1
·General Hospital
MEDRAD VERIS MR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·BAYER MEDICAL CARE, INC.·Product code MHX·March 21, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PROGRAMMING WAND
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022