17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
AUKUFLEX(TM) RADIATION RESISTANT GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VuePoint
FDA UDI
Nuvasive, Inc.·00887517177421·VuePoint Cross Conn, 3.5x42mm Fixed Rod
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 4, 2019
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·June 28, 2019
SYRINGE BOIN TUBE 10ML 21G 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·October 4, 2019
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MICROMANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 9, 2019
ADULT BREATHING CIRCUIT DUAL HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 30, 2014
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 17, 2010
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·October 18, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024