18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033451·Robot Pack
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
FDA 510(k)
FDA Class 2
·Ophthalmic
ALOKA SSD-3500 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 15, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
GENTLE POWER LUX CONTRA ANGLE 25LPA
FDA Adverse Event
Malfunction
·KAVO DENTAL GMBH·Product code EFB·May 15, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 27, 2014
SCREW-IN
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023