2,086 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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6430 MyLabX75, 6430 MyLab XPro75
FDA 510(k)
FDA Class 2
·Radiology
Thino Roth Bracket, .022, Mini Size, UR1
FDA UDI
Astar Orthodontics Inc.·06941673501545·
Temena
FDA UDI
Temena GmbH·03700339712076·Stimulation needle 20º bevel 21G x 120 mm
Temena
FDA UDI
Temena GmbH·03700339711888·Stimulation needle 45º bevel 21G x 120 mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...
STERISPINE LC CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
Axon Therapy
FDA 510(k)
FDA Class 2
·Neurology
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 29, 2021
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 24, 2021
INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 29, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 8, 2013
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 27, 2021
640G INSULIN PUMP MMT-1712K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 19, 2022
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 27, 2021
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 29, 2021
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code MCM·September 20, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FCY·July 21, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX OFFICE·Product code FCY·July 21, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FRN·February 27, 2024