13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Triever24, Triever20
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini Twin
FDA UDI
Rmo, Inc.·00885797652812·ROTH MINI LOW PROFILE 022 HK/345 5-5 20EA
CoRoent
FDA UDI
Nuvasive, Inc.·00887517629340·CoRoent Ant TLIF Ti, 11x13x40mm 12°
Richard-Allan® Needle Straight Cutting
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113219193·Intent to be used with suture material for tiss...
TLC Uni Knee Tibial Plate
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077105·
VISULAS 532S
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLOHEALTH STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
STRATTICE
FDA Adverse Event
Injury
·LIFECELL CORPORATION·Product code FTM·August 16, 2011
4.5MM CURVED BROAD LCP® PLATE 16 HOLES/300MM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HRS·October 30, 2014
ACCESS® ACCUTNI?
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·July 9, 2013
TMJ Arthroscopy Drape, 85''x 96''
FDA Enforcement
Class II
·Terminated·Microtek Medical Inc.·May 18, 2022
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024