10 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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E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
FDA 510(k)
FDA Class 1
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496051077·MARLENE POIS 70, SIZE M, MOSTO, GRADUATED COMPR...
LUBRIGEL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EASYLINK
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JQP·November 25, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·April 10, 2013
SHILEY 4DCT
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO·Product code BTO·May 21, 2008
SIGMA 300 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·April 12, 2011
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010
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