9 results · 21ms · Sources: EU EUDAMED, US FDA

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COSTORSOL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS

FDA 510(k)
FDA Class 2 ·Radiology

DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

FDA Adverse Event
Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·April 29, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 10, 2011

SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE TRAOCULA

FDA Adverse Event
Injury ·STAAR SURGICAL CO.·Product code HQL·July 29, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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