3,202 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BRIGHTMATTER NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV
LEONE SPA
FDA UDI
LEONE SPA·08033707011088·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 24
OsteoMed
FDA UDI
OSTEOMED LLC·00845694038768·2.0mm Champy Plate, Long, Left
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071147440·14F x 2.0cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150068·14F x 2.0cm MiniSPC Low Profile Suprapubic Cath...
TI-MAX X450
FDA 510(k)
FDA Class 1
·Dental
RPM RESPIRATORY GATING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 28, 2011
630G INSULIN PUMP MMT-1715KL 630G
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·February 29, 2024
630G INSULIN PUMP MMT-1715KR 630G
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·December 10, 2024
PUMP MMT-1884L MM780G BLE 3.0 MG/ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 10, 2024
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code MCM·May 13, 2024
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 7, 2024
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 3, 2025
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 3, 2025
COCHLEAR OSIA OSI200 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·June 13, 2024
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
FDA Adverse Event
Malfunction
·ZYNO MEDICAL, LLC·Product code FRN·March 21, 2024