10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDO CATCH GOLD
FDA Adverse Event
Injury
·DAVIS & GECK CARIBE LTD·Product code GCI·June 11, 2018
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123090·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 75mm
ISOPROPANOL HEMOGLOBIN STABILITY TEST
FDA 510(k)
FDA Class 2
·Hematology
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS® TOXO IGG
FDA Adverse Event
BECKMAN COULTER, INC.·Product code LGD·February 17, 2012
IVS TUNNELLER DEVICE
FDA Adverse Event
Injury
·BALLYMONEY - USS·Product code FTL·January 11, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·July 9, 2014
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023