9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HME-10 (TM)
FDA 510(k)
FDA Class 1
·Anesthesiology
VuePoint
FDA UDI
Nuvasive, Inc.·00887517177018·VuePoint Cross Connector, 3x54mm Rod
AUTOSTAT II ENA-6 PROFILE ELISA
FDA 510(k)
FDA Class 2
·Immunology
SCALP DURA RETRACTOR, MODEL KS00474
FDA 510(k)
FDA Class 2
·Neurology
TRI-LOCK BPS SZ 9 STD OFFSET
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 30, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 3, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·November 12, 2010
PRIMATRIX MESHED 2 X 2CM
FDA Adverse Event
Death
·TEI BIOSCIENCES INC·Product code KGN·January 17, 2024
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