10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: ARTHREX INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
KEY SURGICAL, INC.·10849771049224·K-Wires, Single trocar, .028-inch (.7mm) diamet...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012634·K-Wires, Single trocar, .028-inch (.7mm) diamet...
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 2, 2026
DISPOSABLE MICROKERATOME BLADES-PE
FDA 510(k)
FDA Class 1
·Ophthalmic
REUSABLE GLASS SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 22, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·April 27, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008
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