9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAYON NEUROLOGICAL SPONGE
FDA 510(k)
FDA Class 2
·Neurology
AXSOS
FDA UDI
Stryker GmbH·07613154093175·Metal Base - Instruments
ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUREONE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 30, 2014
H9101-OVAL BURR
FDA Adverse Event
Malfunction
·ASCENT HEALTHCARE SOLUTIONS·Product code HRX·November 12, 2010
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 29, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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