9 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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MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450297537·
GUIDANT RETRIEVER DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
VIEWSTATION
FDA 510(k)
FDA Class 2
·Radiology
CURRENT RF DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 3, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 17, 2011
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 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