13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHROMA, MODEL: RZ153C
FDA 510(k)
FDA Class 2
·Cardiovascular
SARSTEDT NEEDLE PROTECTOR
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: STACKABLE CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZL·September 6, 2017
ELECTROSURGICAL COAGULATION FOR AESTHETIC
FDA Adverse Event
Injury
·F CARE SYSTEMS USA LLC·Product code ONQ·November 22, 2013
RETAIN-SLEEVE LONG F/MATRIX 5.5
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·April 29, 2013
UNO
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·April 28, 2011
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 28, 2008
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
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