8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex TightRope II
FDA 510(k)
FDA Class 2
·Orthopedic
MILAGRO
FDA UDI
Medos International Sàrl·10886705026395·MILAGRO ADVANCE INTERFERENCE SCREW Non-absorbab...
Q-SWITCHED ND:YAG LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
FDA 510(k)
FDA Class 2
·Immunology
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 12, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 11, 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