12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
FDA 510(k)
FDA Class 2
·Neurology
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
UNKNOWN COPELAND SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·April 14, 2017
COPELAND SH HUM SZ4 STND PLUS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·June 8, 2016
UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·October 21, 2016
UNKNOWN COPELAND RESURFACING SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·May 16, 2017
UNKNOWN COPELAND SHOULDER GLENOID COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·July 5, 2017
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·March 14, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 13, 2008
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024