25 results · 22ms · Sources: EU EUDAMED, US FDA

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CustomizedBone Service

FDA 510(k)
FDA Class 2 ·Neurology

TALOS®-C

FDA UDI
SpineArt SA·07640375236432·STERILE TALOS®-C (HA) PEEK PLANAR IBFD

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167521607070·

Vusion CS Plus

FDA UDI
Ortho Development Corporation·00822409025527·16 mm x 7 mm x 7 Degree Lordotic

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 7, 2018

REPROCESSED PINS

FDA 510(k)
FDA Class 2 ·Orthopedic

AESCULAP BIPOLAR ACETABULAR CUP

FDA 510(k)
FDA Class 2 ·Orthopedic

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 13, 2018

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·May 30, 2018

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 7, 2018

CLEARLINK PACLITAXEL SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

SPINOUS PROCESS TALL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·May 13, 2019

ORTHOPEDIC STEREOTAXIC INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·November 26, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011

AED PLUS

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008

CLEARLINK SOLUTION ADMINISTRATION SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

ALERE DETERMINE HIV-1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ORGENICS LTD·Product code MZF·April 3, 2017

CLEARLINK SOLUTION ADMINISTRATION SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

1823260-2017-02065

FDA Adverse Event
Malfunction ·September 25, 2017