14 results
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18ms
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Sources: EU EUDAMED, US FDA
WAKO(TM) AUTOKIT TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Archon
FDA UDI
Nuvasive, Inc.·00887517303301·Archon Screw, 4.0x12mm S.T. Fixed Recon
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515225763·Exodontia Elevator, #303
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880312220·dentaform® Snap, tooth 46,size 12/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880312180·dentaform® Snap Band, tooth 46,size 12/Roth 18
NA
FDA UDI
STRYKER CORPORATION·07613327055429·[Cutting Loop Electrode, .012 wire, 24 Fr ¿ 90 ...
150 DRIVER/REAMER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AUTONOM
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·June 18, 2014
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 19, 2012
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 22, 2010
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
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015