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