11 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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CENTURY MODEL 105C
FDA 510(k)
FDA Class 1
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450486276·
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SMALL ELECTRIC DRIVE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014
OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·December 18, 2023
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·May 6, 2013
MEDIVATORS ENDOGATOR
FDA Adverse Event
MEDIVATORS·Product code OCX·September 16, 2014
AMPHIRION DEEP PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·INVATEC INNOVATIVE TECHNOLOGIES SPA.·Product code DQY·April 19, 2011
NUVASIVE HELIX ACP SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·June 1, 2022
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