10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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YosemiteView 4343W/YosemiteView 3643W
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982159793·3.5MM 90 DEG CANN LC-ANGLED BLADE PLATE 5 HOLES...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112519·BARRON VACUUM TREPHINE 8.0MM
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 7, 2023
VIDAS FT4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 1, 2011
2250051-2008-00396
FDA Adverse Event
Malfunction
·Product code JTC·August 1, 2008
5.0 CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014