13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALPHALOK Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Martin-Lewis Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902215582·BD BBL™ Martin-Lewis Agar
DIAZYME HSCRP POC TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
MicroPen EVO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMP TM 3.7MM MTX FULL,11.5MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·October 27, 2025
IMP TM 3.7MM MTX FULL,11.5MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·October 27, 2025
BD BBL¿ MARTIN-LEWIS AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JTY·August 11, 2021
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NTE·November 5, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 24, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·July 3, 2013
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTY·March 17, 2021
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 14, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025