8 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CATHETER, INTRAUTERINE AND INTRODUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZEST NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
AXIOM ARISTOS VX PLUS
FDA Adverse Event
Injury
·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LGD·February 10, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 6, 2014
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 24, 2016