10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCOPESCRUBBER(TM)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
FDA 510(k)
FDA Class 2
·Cardiovascular
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 7, 2021
ELLIPSE DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 8, 2013
NEUROFORM STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code NJE·November 18, 2010
ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·June 30, 2014
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 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