37 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
FDA 510(k)
FDA Class 2
·Immunology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092131473·NobelActive™/Conical-compatible NP 17° Multi-Un...
Provena Midline
FDA UDI
Bard Access Systems, Inc.·00801741188770·Catheter Placement Kit
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116685·NobelActive™/Conical-compatible NP 17° Multi-Un...
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361008200·PedFuse ReTurn, Hex, CNL, 8.0mm x 80mm
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
ASNIS III CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 15, 2015
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 15, 2015
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 17, 2015
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 15, 2015
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 15, 2015
HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 15, 2015
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 22, 2017
M2A-MAGNUM PF CUP 48ODX42ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 6, 2022
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC·Product code HWX·February 24, 2011
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·February 15, 2008
MLRY-HD POR FMRL 11X160MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 13, 2018