10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Miltex N-Tralig Intraligamentary Syringe
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550131·GENUMEDI PT KNEE SUP SILVER L EW IV
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016742·MFx 125 Degree Angulated Locking Contoured Reco...
LACTOSORB* 1.5MM SYSTEM TEMPLATE
FDA UDI
BIOMET MICROFIXATION, INC·00841036078553·
VISIOPLAST ACRYLIC RESIN
FDA 510(k)
FDA Class 2
·Neurology
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 5, 2014
TRI TS BASEPLATE SIZE 3
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·June 21, 2011
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 3, 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