12 results
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19ms
·
Sources: EU EUDAMED, US FDA
DATA-ZYME UREA NITROGEN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM
INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PLMA DVC V11.51 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·October 23, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010
CONMED
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·September 15, 2008
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·December 25, 2013
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024