Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Medica Corporation with 56 510(k) clearances, 4 device recalls and 1 AI-enabled device. The most recent is a device recall dated Dec 31, 2025: Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 31, 2025 | Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.Class II · A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevati | Device recalls |
| Jul 26, 2024 | EasyStat 300K220328 · CGA | 510(k) clearances |
| Sep 26, 2023 | EasyStat 300K220396 · CEM | 510(k) clearances |
| Jan 27, 2023 | EasyStat 300K211559 · CHL | 510(k) clearances |
| Feb 6, 2019 | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washClass II · Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) | Device recalls |
| Nov 21, 2017 | Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use wiClass II · The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyz | Device recalls |
| Apr 11, 2017 | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration leveClass II · Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values. | Device recalls |
| Dec 1, 2016 | EasyLyte Na/K/Cl/Ca AnalyzerK152327 · JFP | 510(k) clearances |
| May 13, 2014 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIALK130080 · JHY | 510(k) clearances |
| May 15, 2013 | EASYRA CREATININE REAGENTK123586 · CGX | 510(k) clearances |
| Mar 1, 2013 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK123802 · CIG | 510(k) clearances |
| May 14, 2012 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK120497 · LCP | 510(k) clearances |
| May 12, 2010 | EASYCELL CELL LOCATORK092116 · Hematology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
