15 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REVOLUTIONFULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
FDA 510(k)
FDA Class 2
·Orthopedic
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PB560 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 22, 2011
PB560 VENTILATOR X1
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011
SPINNING SPIROS® CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025
HOLDING SLEEVE-STANDARD FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·April 29, 2013
GLOBAL ADVANTAGE STEM 12 MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWS·May 3, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 25, 2008
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 17, 2018
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 22, 2020
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