10 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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i-STAT EG6+ cartridge. List Number: 03P77-25.
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT EG7+ cartridge. List Number: 03P76-25.
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025
i-STAT EG6+ cartridge; List Number: 03P77-25;
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026
i-STAT G3+ cartridge; List Number: 03P78-26;
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026
i-STAT EG7+ cartridge; List Number: 03P76-25;
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBZ·January 20, 2022
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
FDA Recall
Open, Classified
·Handpiece Headquarters·Product code EBZ·April 4, 2018
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 Recall
Open, Classified
·Dental EZ Group Star Dental Division·Product code ELC·May 30, 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 Recall
Open, Classified
·Dental EZ Group Star Dental Division·Product code ELC·May 30, 2024