37 results · 22ms · Sources: EU EUDAMED, 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