8 results
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26ms
·
Sources: EU EUDAMED, US FDA
CIN-SHEAR
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435064111·MCD Screw 4.0 x 52 mm cannulated M3
partia...
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VERAPLUG
FDA 510(k)
FDA Unclassified
·Unknown
M2A-MAGNUM PF CUP 54ODX48ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 30, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·November 20, 2012
PATIENT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FRK·September 10, 2010
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024