8 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEMLITE (PLASTIC EYEGLASS FRAMES)
FDA 510(k)
FDA Class 1
·Ophthalmic
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471182895·.022 U/R Std. Weld Size #21
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
FDA 510(k)
FDA Class 3
·Orthopedic
syngo.CT Cardiac Planning
FDA 510(k)
FDA Class 2
·Radiology
NELLCOR OXIMAX N-65
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·March 10, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 1, 2012
RELIANCE PF HIP #2/12MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code JDI·July 21, 2010
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION PPS, kit number LLCI66; f) C-Section drape Pack, kit number RBCS12R; g) C-Section, kit number THCS49B; h) C-SECTION PACK (PS 020632), kit number UICS50AG;
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·February 7, 2024