6 results
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7ms
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Sources: EU EUDAMED, US FDA
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
FDA Enforcement
Class II
·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
FDA Enforcement
Class II
·Ongoing·Dental EZ Group Star Dental Division·July 3, 2024
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
FDA Enforcement
Class II
·Ongoing·Dental EZ Group Star Dental Division·July 3, 2024
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024