20 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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Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
C6 Sensor 2.0 rebuilt
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C6R20·
MULTI-STIM, MODEL MS-100
FDA 510(k)
FDA Class 2
·Neurology
RANDOX HAEMOGLOBIN A1C
FDA 510(k)
FDA Class 2
·Hematology
Widex
FDA UDI
Widex A/S·05706069773767·Widex EVOKE E-FS, Telecoil, RC coil
PDS PLATE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NHB·October 24, 2019
PDS PLATE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NHB·October 24, 2019
AMS ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code MIP·October 27, 2014
LEGACY II SR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
SYSTEM 2000
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code ILM·June 27, 2013
GORE VIABAHN ENDOPROSTHESIS - 3
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code PFV·September 26, 2019
VALIANT CAPTIVIA - FF
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 10, 2019
SYNVISC ONE
FDA Adverse Event
Injury
·GENZYME CORPORATION(RIDGEFIELD)·Product code MOZ·August 10, 2017
BELOTERO BALANCE
FDA Adverse Event
Injury
·ANTEIS S. A.·Product code LMH·July 31, 2019
MEDTRONIC NAVIGATION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·September 19, 2019
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·September 19, 2019
UNKNOWN ENDO GIA SULU
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 24, 2019
EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·February 1, 2019
BELOTERO BALANCE
FDA Adverse Event
Injury
·ANTEIS S. A.·Product code LMH·July 31, 2019
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