11 results
·
127ms
·
Sources: EU EUDAMED, US FDA
DENTOLOCK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PAQ. 210x140x200/QT-HS/FQW210-2-140 (C/
FDA UDI
AB MEDICA GROUP, S.A.·08428763054191·
Bosworth Hydrox
FDA UDI
Harry J Bosworth Company·H66809210711·Cavity Liner Base & Catalyst Dentin Kit
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112335·SURG-I-BAND LIME GREEN
PCCS GRAFT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Niti-S Biliary Slim M Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 9, 2010
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·January 17, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024