13 results
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31ms
·
Sources: EU EUDAMED, US FDA
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 17, 2022
TI-DBLE LEAD CORT SCR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·August 24, 2018
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 17, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 17, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 17, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 17, 2022
MODIFICATION TO: WINNER ST-2 STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
BIRD TBIRD LEGACY VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
AED PRO
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 3, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 14, 2011
CRE BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KOG·June 18, 2008
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