10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HyperLight Portable X-ray Unit
FDA 510(k)
FDA Class 2
·Dental
Capo Slow Flow clear, 2 g
FDA UDI
Schütz Dental GmbH·ESDG2320681·Capo Slow Flow is a light-curing, flowable, hig...
NA
FDA UDI
SYNTHES (U.S.A.) LP·10886982159830·3.5MM 90 DEG CANN LC-ANGLED BLADE PLATE 6 HOLES...
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
FDA 510(k)
FDA Class 2
·Cardiovascular
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
FDA 510(k)
FDA Class 2
·Cardiovascular
STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·February 7, 2022
HEARTSTREAM XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 7, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code MNH·July 17, 2013
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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