10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLOM-SINGER INDWELLING TEP OCCLUDER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LEONE SPA
FDA UDI
LEONE SPA·08033707065814·EXTRAORAL ELASTICS 3/16" 8 oz
INPATH E2 COLLECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MS-ONE, MODEL MS-1
FDA 510(k)
FDA Class 2
·Neurology
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 15, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 5, 2013
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·September 16, 2014
LIFECARE PCA 3 V5.06
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·April 14, 2011
Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·February 17, 2016
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