9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CELL-DYN 3000 CONTROL
FDA 510(k)
FDA Class 2
·Hematology
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295124019·Antibacterial Clear Bandages; Active Ingredient...
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
FDA 510(k)
FDA Class 1
·General Hospital
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
FDA 510(k)
FDA Class 3
·Cardiovascular
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·June 30, 2014
SPECTRANETICS LASER SHEATH II
FDA Adverse Event
Death
·SPECTRANETICS CORPORATION·Product code MFA·January 8, 2013
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 12, 2010
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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