15 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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MODIFIED 650 MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·January 9, 2026
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478035·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478042·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132090·Trial, TLIF, 27L OB CRV 7Deg, 9mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033478059·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm
RAPIDIA
FDA 510(k)
FDA Class 2
·Radiology
PROGNOST ES, MODEL 0302 0000
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013
CONTINUUM HB RIM IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HWA·March 8, 2011
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HWC·March 14, 2008
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 20, 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