15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYPATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
Aequalis™ Adjustable Reversed
FDA UDI
TORNIER, INC.·00846832059867·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197311137·Yankauer nasal speculum
190mm,...
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 14, 2002
TRU LEGIONELLA
FDA 510(k)
FDA Class 2
·Microbiology
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH II
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 30, 2002
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 29, 2014
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·May 22, 2013
CLARITY DDDR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE CONTINUING CARE·Product code FNL·October 1, 2014
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 6, 2025
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015