13 results · 27ms · Sources: EU EUDAMED, US FDA

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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