5 results
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7ms
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Sources: EU EUDAMED, US FDA
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 17, 2021
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 3, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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