11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GAMMA LEWIS BLOOD GROUP SUBSTANCE
FDA 510(k)
FDA Class 2
·Hematology
LEONE SPA
FDA UDI
LEONE SPA·08033707056577·DB TUBE MIM 22/18/51 OCC LEFT
Bonecam
FDA UDI
MEDLINE INDUSTRIES, INC.·00818614022185·Drill with depth stop, 3.3mm
ACUMED
FDA UDI
Acumed LLC·10806378102080·2.8mm X 450mm Threaded Guide Wire
ROTATING GAMMA SYSTEM INFINI (INFINI)
FDA 510(k)
FDA Class 2
·Radiology
TCD 100M, PWD13 TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·May 9, 2014
NIGHT GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·October 19, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP·Product code LZG·August 9, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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