13 results
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17ms
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Sources: EU EUDAMED, US FDA
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
FDA 510(k)
FDA Class 2
·Immunology
HOFFMANN
FDA UDI
Stryker GmbH·07613327297751·LRF Web Application
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983031·posteriors; shade A3.5; size S; lower jaw
Dakewe
FDA UDI
Shenzhen Dakewe Bio-engineering Co., Ltd·06973471960507·1 mL of Inactivated Transport Medium in screw-c...
Trinias
FDA UDI
SHIMADZU CORPORATION·04540217058020·
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
NexGen®
FDA UDI
Zimmer, Inc.·00889024218123·
12/14 ARTICUL 40MM M SPEC-2
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LPH·February 28, 2013
PIN LNR CONS NEUT +4 36IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWZ·February 7, 2011
TORQUE LIMITING ATTACHMENT 0.8NM/QUICK COUPLING
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·August 6, 2014
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code KTT·July 26, 2018
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
FDA Enforcement
Class II
·Terminated·Stryker GmbH·October 3, 2018