10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515149724·Pitanguy Flap Demarcator Grasping Forcep, 6-1/8"
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
E-Z HOLD - #4060
FDA 510(k)
FDA Class 1
·General Hospital
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 22, 2014
OCCIPIT-SCR Ø4.5 L8 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KWP·February 15, 2013
ADVANTA
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2010
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
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