7 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·July 31, 2013
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Enforcement
Class II
·Ongoing·EMPATICA SRL·November 1, 2023
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014