6 results · 12ms · Sources: EU EUDAMED, US FDA

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ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

FDA Enforcement
Class II ·Terminated·Abbott Laboratories, Inc·March 13, 2019

Laborie Transducer Cartridge with Luer Lock Reference: DIS130

FDA Recall
Terminated ·Laborie Medical Technologies·Product code FEN·October 4, 2006

Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740

FDA Recall
Terminated ·Ormco Corporation·Product code DYH·October 31, 2007

Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.

FDA Recall
Terminated ·Medtronic Perfusion Systems·Product code DWE·August 1, 2007

Olympus Sterile Optical Laser Fiber, single use and reusable

FDA Enforcement
Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

FDA Enforcement
Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016