11 results
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18ms
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Sources: EU EUDAMED, US FDA
MICRO-AIRE CEMENT REMOVAL TOOLS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880324220·dentaform® Snap, tooth 46,size 24/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880324180·dentaform® Snap, tooth 46, size 24/Roth 18
NA
FDA UDI
STRYKER CORPORATION·07613327063486·24 Fr. Standard Flow Resectoscope Sheath
Patriot Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPNOMETER MODEL 47210A
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 30, 2014
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 19, 2012
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 30, 2015
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
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020