13 results
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27ms
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Sources: EU EUDAMED, US FDA
AXIOM ARISTOS FX PLUS
FDA 510(k)
FDA Class 2
·Radiology
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610541·Mini Sprint-Brackets 5-5 McLaugh/Benn/Trev. .02...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated
RADS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER
FDA 510(k)
FDA Class 2
·Radiology
E500 VENTILATOR SYSTEM
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016
I-STAT ACT CELITE CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JBP·December 10, 2012
QUANTUM TTC BILIARY BALLOON DILATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNQ·April 9, 2013
IMPACT
FDA Adverse Event
Other
·IMPACT INSTRUMENTATION, INC·Product code BTA·February 22, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 12, 2008
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
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