12 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COLLES C SERIES FRAME STERILE PACK
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496003397·NAOMI 70, SIZE S, BLU SCURO, GRADUATED COMPRESS...
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159022803·Puskas™ Jacobson Micro Needle Holder
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
FDA 510(k)
FDA Class 2
·Clinical Toxicology
25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016
DISTRACTOR TIP FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·February 28, 2013
PRESTIGE CERVICAL DISC SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code MJO·March 1, 2011
STERRAD NX STERILIZATION SYSTEM
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 21, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024