9 results · 19ms · Sources: EU EUDAMED, US FDA

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IMT.LAB SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

TRIO LX SMALL CONNECTOR

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011

REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING

FDA 510(k)
FDA Class 2 ·Anesthesiology

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 18, 2013

ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·April 8, 2011

ZENITH RENU AAA ANCILLARY GRAFT

FDA Adverse Event
Injury ·COOK INC.·Product code MIH·June 18, 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

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