10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
CAPSTONE® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994387240·SPACER 2991136 CAPSTONE PEEK 11X36
800 P37,R4,1LD,RAD,DIODE,STKR
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828100809·800 P37,R4,1LD,RAD,DIODE,STKR
Access CT
FDA 510(k)
FDA Class 2
·Radiology
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
FDA 510(k)
FDA Class 2
·General Hospital
ETEST FOSFOMYCIN FM 1024 WW B30
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JWY·April 16, 2020
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024