7 results
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7ms
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Sources: EU EUDAMED, US FDA
Metasul¿ LDH¿ Head Rx Sterile
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·November 14, 2012
Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
FDA Enforcement
Class II
·Terminated·Welch Allyn Inc Mortara·April 28, 2021
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014
Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
FDA Enforcement
Class II
·Terminated·Sentinel CH SpA·October 2, 2019
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 23, 2020
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30
FDA Enforcement
Class II
·Terminated·Sentinel CH SpA·October 2, 2019
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
FDA Enforcement
Class II
·Terminated·LDR Spine USA, Inc.·October 12, 2016