12 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
FDA 510(k)
FDA Class 2
·Radiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450409190·
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
OPUS 20, MODEL 1ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOTINGHM SHLDR HUM HEAD 48X17 OFFSET
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·January 19, 2016
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
DIDECO COMPACTFLO EVOLUTION OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 3, 2013
INSTA DENTURE RELINE KIT
FDA Adverse Event
Malfunction
·Product code EBI·September 10, 2014
SPECTRA OPTIA EXCHANGE SET
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·May 5, 2011
SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020
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