9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Brigade
FDA UDI
Nuvasive, Inc.·00887517963956·Brigade Lateral Trial, 10x38x32mm 15°
EZ-MISTER
FDA 510(k)
FDA Class 2
·Anesthesiology
NEOLYNX SCREENING APPLICATION MANAGER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 16, 2010
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DRE·December 31, 2012
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 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