12 results
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26ms
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Sources: EU EUDAMED, US FDA
LATEX SURGICAL STERILE GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Nexxis OR
FDA UDI
Barco NV·05415334002425·MNA-120 ENC ANA CM + CBL 5M
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228535·Hoe Excavator, .33mm long tip ang 90deg
ROUGHRIDER
FDA 510(k)
FDA Class 1
·Physical Medicine
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
FDA 510(k)
FDA Class 2
·Orthopedic
ADULT BREATHING CIRCUIT DUAL HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·June 16, 2009
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 30, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION·Product code LGW·January 2, 2013
DUR MAR +4 10D LNR 36X54
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 12, 2010
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·August 8, 2025
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