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