15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Esophageal TTS Stent
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGXO
FDA UDI
Sbo Hearing A/S·05714464056156·AGXO F100 MINIRITE T C091
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AERO CHROME* Breathable Performance Surgical Gowns
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NAIL HOLDING SCRE WGAMMA3 8X35MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 19, 2024
OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code GFA·November 10, 2014
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·September 9, 2011
4MM FLUTED BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
FDA Enforcement
Class II
·Ongoing·Merge Healthcare, Inc.·March 26, 2025
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019