9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HEARING AID MODEL F8H ANL F8T
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515200081·Fukuda Shoulder Ret, large
PITStop® implant
FDA 510(k)
FDA Class 2
·Orthopedic
NEXFIX COMPRESSION STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·April 24, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 29, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 3, 2012
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025