23 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBI ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VUELOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752144712·AirLife™ Volume Ventilator Circuit For Use with...
AirLife™
FDA UDI
AIRLIFE·10889483570531·AirLife™ Volume Ventilator Circuit For Use with...
T2Candida® Cartridge Kit
FDA UDI
T2 BIOSYSTEMS, INC.·M70890017940·The T2Candida components used to load the patie...
PET SHIPPING SYSTEM
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175001813·Shipping System, PET, Double-Ended Pig, Single
Two Light Blue ComfyRayXT Size 2 Holders + G-Rings and Rods
FDA UDI
CLIKTECH LLC·00856200001794·Two Light Blue ComfyRayXT Size 2 Holders + G-Ri...
IPG Medical
FDA UDI
IPG Medical Corporation·00810071230936·IPG Medical, Flat Tip, Single-Use Laser Fiber, ...
5 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 5, 2017
5 ML BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 28, 2017
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO MARSPO2, MODEL 2001
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO STERNAL SAW II
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·June 30, 2014
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 3, 2011
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·February 19, 2008
T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.
FDA Enforcement
Class II
·Terminated·T2 Biosystems Inc·September 21, 2016