13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIBERGRAFT BG MORSELS
FDA 510(k)
FDA Class 2
·Orthopedic
STRAUMANN MEMBRAGEL
FDA 510(k)
FDA Class 2
·Dental
EMG - ESSENTIAL GAS MODULE, MODEL M1013A
FDA 510(k)
FDA Class 2
·Anesthesiology
FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FGB·October 19, 2022
FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FGB·October 20, 2022
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FRN·August 29, 2025
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026