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

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GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

REBOUND HRD

FDA Adverse Event
Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

SERENOCEM, MODEL BC 010

FDA 510(k)
FDA Class 2 ·Dental

STAT PROFILE PHOX PLUS L ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AVIATOR ASSY TWO LEVEL PLATE SIZE 28

FDA Adverse Event
Injury ·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016

BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·December 12, 2018

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·April 29, 2013

3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 40MM

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code KTT·September 12, 2014

GOLD RELOAD

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 10, 2011

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