12 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNOCTA ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
MAGNETOM RHAPSODY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 23, 2013
ISOFLEX OPTIM LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·September 9, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 13, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·October 6, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·July 15, 2025
GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 25, 2016
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code ELC·September 9, 2016
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 23, 2018
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