13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Digital Automatic Wrist Blood Pressure Monitor MD3900
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131291776·ALTA2 PRO, MINIRITE 312 WL CBU
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837089078·
FLAATZ 560
FDA 510(k)
FDA Class 2
·Radiology
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECTRIC PEN DRIVE 60,000 RPM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWE·June 7, 2013
TI ECCENTER - STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSD·June 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
ASPHERE M SPEC 12/14 36 +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 14, 2012
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 14, 2012
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·February 21, 2024
TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG
FDA Adverse Event
Injury
·TORNIER INC·Product code KWS·March 8, 2024
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014