21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Automated ankle brachial pressure index measuring device, MESI mTABLET system
FDA 510(k)
FDA Class 2
·Cardiovascular
HHM
FDA UDI
Oticon A/S·05707131352477·G500 S, MINIRITE T 312 2.4G C094 HHM
10M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp
24M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010441·24M - Southwest Gas Corp
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805677·Barron Areola Marker, 40/44/48/52mm
COBRA COOLED SURGICAL PROBE, MODEL 1596X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
FDA 510(k)
FDA Class 2
·Orthopedic
Trilogy® Trabecular Metal™
FDA UDI
Zimmer, Inc.·00889024118478·
ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025
STOCKERT S3 GAS BLENDER
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014
HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL, INC·Product code FMJ·September 16, 2014
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DTK·August 11, 2011
ATTUNE PS RP INSRT SZ 7 7MM
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·July 2, 2013
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024
SORIN S3 GAS BLENDER
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
FDA Enforcement
Class II
·Terminated·Canon Medical System, USA, INC.·September 12, 2018
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 3, 2013
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016