10 results
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19ms
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Sources: EU EUDAMED, US FDA
URINE COLLECTION BAG TYPE 740AP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leica Biosystems
FDA UDI
Leica Biosystems Richmond, Inc.·20849832026772·Microbiopsy Cassettes, Yellow
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828027350·ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
STONE GRASPING BASKET, MODEL PD-T1 2115
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASCENT XXL OPEN BOX FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
ARTICULEZE M 28MM 5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 9, 2014
EXPRESS 2 CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·October 24, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 17, 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