13 results
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18ms
·
Sources: EU EUDAMED, US FDA
BIVONA ENDOTRACHEAL TUBE STYLET
FDA 510(k)
FDA Class 1
·Anesthesiology
Narrow Slotted Driver
FDA UDI
STERNGOLD DENTAL LLC·00841549117718·Long Shank, Hand Driver
10MM MODULAR BIO-CORE TAP
FDA UDI
Biomet Orthopedics, LLC·00880304480070·
Modular Bio-Core Tap
FDA UDI
Biomet Orthopedics, LLC·00887868567995·
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482129845·Symmetry® Needle, Puncture Needle Aspirator, 5....
AHYDRON DENTAL CLEANING AGENT
FDA 510(k)
FDA Class 2
·Dental
PULPDENT OIL FREE SURFACE PREPARATION PASTE
FDA 510(k)
FDA Class 1
·Dental
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·January 30, 2015
SPHERX PPS SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code NKB·June 10, 2014
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 22, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024