9 results
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19ms
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Sources: EU EUDAMED, US FDA
CRANEX NOVUS
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040119843·NITINOL REVERSE CURVE ARCHWIRE .017 x .025 UPPER
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION OF NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code KOG·March 28, 2013
PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC·Product code DXE·June 20, 2008
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 19, 2011
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