11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Face Mask (L 175*95mm)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RAYSTATION
FDA 510(k)
FDA Class 2
·Radiology
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN DEPUY BONE SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HWC·November 6, 2014
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011
COULTER® AC*T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 16, 2013
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020