8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAPITEX (R) CRP NEW
FDA 510(k)
FDA Class 2
·Immunology
LINER: MPACT FLAT PE HC LINER 32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 28, 2020
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 20, 2010
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 9, 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