11 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MOSFET AUTOSENSE, MODEL TN-RD-60
FDA 510(k)
FDA Class 2
·Radiology
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033471043·
MEDISYSTEMS LUER ACCESS INJECTION SITE
FDA 510(k)
FDA Class 2
·General Hospital
ENTEC EVAC PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
CANNULA
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 20, 2013
INJECTOR, OPTIVANTAGE DH W/RFID
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·March 8, 2011
PULMONETIC
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC·Product code CBK·March 14, 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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025