8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAS GENERATING KIT SYSTEM FOR CAMPYLOB.
FDA 510(k)
FDA Class 1
·Microbiology
THE BUZZ FACIAL TONING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DRAD3000E/RADREX-I
FDA 510(k)
FDA Class 2
·Radiology
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 9, 2014
RUSCH AGT NASAL CUFFED ET TUBE, 6.0MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BSR·October 18, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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