9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982068·posteriors; shade B4; size M; upper jaw
Sklar
FDA UDI
SKLAR CORPORATION·10649111380839·MICRO ADSON FORCEP SERR 6 IN
E. COLI PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
Erran Dental Zirconia
FDA 510(k)
FDA Class 2
·Dental
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 8, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LGD·February 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024