13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
FDA 510(k)
FDA Class 2
·General Hospital
ORION DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
FDA 510(k)
FDA Class 2
·Radiology
VERSAFITCUP DM ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015
SOL-MILLENNIUM
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·April 14, 2021
CADD
FDA Adverse Event
Malfunction
·Product code FPA·April 14, 2021
CADD
FDA Adverse Event
Malfunction
·Product code FPA·April 14, 2021
2520274-2013-02354
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·May 3, 2013
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·May 2, 2011
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005
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