24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
FDA 510(k)
FDA Class 2
·Cardiovascular
ANSWER HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304252684·
Batrik Brush/Yellow/BD 3mm/BL 25mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521008595·Brush/Yellow/BD 3mm/BL 25mm/OL 60cm - Flexible...
Batrik Arc Wire Brushes Single Use
FDA UDI
Batrik Medical Manufacturing Inc·00690521008601·Brush/Yellow/BD 3mm/BL 25mm/OL 60cm - Flexible...
Ortho Shop
FDA UDI
Orthoshop, LLC·00810152071601·0.016 x 0.025 Copper NiTi Wire with Stops Damon...
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
FDA 510(k)
FDA Class 2
·Orthopedic
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA)
FDA Adverse Event
Malfunction
·SIEMENS / HEALGEN SCIENTIFIC LLC.·Product code QKP·June 6, 2023
CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA)
FDA Adverse Event
Malfunction
·SIEMENS / HEALGEN SCIENTIFIC LLC·Product code QKP·June 6, 2023
CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA)
FDA Adverse Event
Malfunction
·SIEMENS / HEALGEN SCIENTIFIC LLC.·Product code QKP·June 6, 2023
CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA)
FDA Adverse Event
Malfunction
·SIEMENS / HEALGEN SCIENTIFIC LLC.·Product code QKP·June 6, 2023
CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA)
FDA Adverse Event
Malfunction
·SIEMENS / HEALGEN SCIENTIFIC LLC.·Product code QKP·June 6, 2023
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 23, 2021
AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 18, 2022
AIRVO2 TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 18, 2022
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 11, 2013
SYMPHONY
FDA Adverse Event
Malfunction
·ELA MEDICAL·Product code DXY·September 16, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 9, 2015
HEATED BREATHING TUBE AND CHAMBER KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 5, 2022