6 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 15, 2013
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 1, 2014
Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.
FDA Recall
Terminated
·Vistakon·Product code LPM·July 16, 2010
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 20, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012