5 results
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32ms
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Sources: EU EUDAMED, US FDA
OraLabs, Inc.
FDA registration
OraLabs, Inc.·2 products·🇺🇸 United States
ORAL-B NIGHTTIME DENTAL GUARD
FDA Adverse Event
Injury
·ORALABS, INC.·Product code OBR·May 24, 2022
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code EFW·December 26, 2025
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JIT·August 7, 2020
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JJX·August 7, 2020