17 results · 20ms · Sources: EU EUDAMED, US FDA

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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