9 results
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17ms
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Sources: EU EUDAMED, US FDA
CUSTOMED ORTHOPEDIC II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AXSOS
FDA UDI
Stryker GmbH·07613154945931·Instrument Tray 2 (Middle)
ELECSYS TOXO IGG CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NICHOLS ADVANTAGE THYROGLOB
FDA 510(k)
FDA Class 2
·Immunology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·June 30, 2014
REPAIR U2 DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·November 12, 2010
X-STREAM
FDA Adverse Event
Malfunction
·DAVOL INC., SUB. C.R. BARD, INC.·Product code GCJ·November 27, 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