8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
CARPAL TUNNEL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
10MM, 33CM RATCHETING HANDLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code KOG·January 4, 2013
ADVIA CENTAUR XP TOTAL HCG (THCG)
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·December 28, 2010
LINEAR 7.5 FR 40CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP.,·Product code DSP·July 2, 2014
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024