11 results
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17ms
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Sources: EU EUDAMED, US FDA
CALCIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022438·PEERLESS 10DEG SGLUFM-10TRQX018 UR
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515136885·Oral Surgery, Elevator #74
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880308220·dentaform® Snap, tooth 46, size 8/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880308180·dentaform® Snap Band, tooth 46, size 8/Roth 18
Prelude
FDA 510(k)
FDA Class 2
·Radiology
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
FDA 510(k)
FDA Class 2
·Dental
SELOX ST 60
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·June 18, 2014
AIRCAST CRYO/CUFF
FDA Adverse Event
Injury
·DJ ORTHOPEDICS DE MEXICO·Product code ILO·October 20, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025