6 results
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8ms
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Sources: EU EUDAMED, US FDA
Latex Dental Dams labeled as Non-Latex Dental Dams
FDA Enforcement
Class II
·Terminated·Coltene Whaledent Inc·August 13, 2014
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
FDA Enforcement
Class II
·Terminated·Dentech Corp.·June 2, 2021
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·January 1, 2014
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.
FDA Enforcement
Class II
·Terminated·Agilent Technologies, Inc.·April 12, 2017
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
FDA Enforcement
Class II
·Terminated·Sam Medical Products·November 5, 2014
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA Enforcement
Class II
·Terminated·Sam Medical Products·March 23, 2022