8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ECHO MM1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Turtle Gun
Device
EU MDD
·
Eu Md Class 2b
·Seawon Meditech Co.,Ltd.·On the market·3 countries
KINETIC CREATININE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPNOMETER W/NEW AIRWAY ADAPTER 47210A
FDA 510(k)
FDA Class 2
·Anesthesiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES·Product code LZG·May 6, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 15, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 10, 2010
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