3 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
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
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018