11 results
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31ms
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Sources: EU EUDAMED, US FDA
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694060325·14mm Angled Locking Screw ID Tag
ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
CADHEALTH SYSTEM, MODEL CHP-001
FDA 510(k)
FDA Class 2
·Cardiovascular
DIGIPAN / DPI
FDA 510(k)
FDA Class 2
·Dental
MO.MA ULTRA
FDA Adverse Event
Injury
·INVATEC SPA·Product code NTE·April 17, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·April 7, 2011
BLUE MAX BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code LIT·June 18, 2008
ANGIODYNAMICS / SMART PORT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code LJT·August 21, 2017
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015