9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Affinity J (Instruments for Microscope)
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074084428·SLEEVE 0903207 DBL GUIDE ASSY 7MM
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228481·Stapedectomy Pick, ang tip 45deg, 5 7/8"
ENDURAMESH, MODEL 762.XXX
FDA 510(k)
FDA Class 2
·Orthopedic
MEDCOMP ULTRA-FLOW CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORE SUMEX DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·June 30, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013
PINNACLE 100 ACET CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 12, 2010
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