Company ยท US
Medica Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2026. Name variants (Inc, Corp, punctuation) are merged.
59510(k) clearances (1 in 12 months)
5recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | 9 |
| CEM | Electrode, Ion Specific, Potassium | 5 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 4 |
| CGA | Glucose Oxidase, Glucose | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 |
| JFP | Electrode, Ion Specific, Calcium | 3 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBJ | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 23, 2026 | K252957 | Pneumo Dissector Hook Ab Medica Sas, FR | GCJ |
| Sep 19, 2025 | K243920 | Purema H Hemoconcentrator - Pediatric Medica USA, Inc. | KDI |
| Jul 26, 2024 | K220328 | EasyStat 300 Medica Corporation | CGA |
| Sep 26, 2023 | K220396 | EasyStat 300 Medica Corporation | CEM |
| Jan 27, 2023 | K211559 | EasyStat 300 Medica Corporation | CHL |
| Dec 1, 2016 | K152327 | EasyLyte Na/K/Cl/Ca Analyzer Medica Corporation | JFP |
| Sep 4, 2015 | K151822 | ab medica irrigation/suction gravity system Ab Medica Sas, FR | GCJ |
| Jul 10, 2014 | K140101 | ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS Ab Medica Sas | GCJ |
| May 13, 2014 | K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL Medica Corporation | JHY |
| May 15, 2013 | K123586 | EASYRA CREATININE REAGENT Medica Corporation | CGX |
| Mar 1, 2013 | K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT Medica Corp. | CIG |
| May 14, 2012 | K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL Medica Corp. | LCP |
| Dec 6, 2011 | K111363 | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL Medica Corp. | JXN |
| Nov 15, 2011 | K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL Medica Corp. | DIC |
| Oct 20, 2011 | K112788 | EASTLYTE NA/K/CA/PH Medica Corp. | CEM |
| Jul 13, 2011 | K101089 | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR Medica Corp. | DCF |
| Jul 12, 2011 | K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT Medica Corporation | LBS |
| May 20, 2011 | K101090 | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS Medica Corp. | CJE |
| Apr 21, 2011 | K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS Medica Corp. | CDQ |
| Apr 4, 2011 | K101088 | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT Medica Corp. | CIX |
| Jan 14, 2011 | K100829 | EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 Medica Corp. | JGS |
| May 12, 2010 | K092116 | EASYCELL CELL LOCATOR Medica Corp. | JOY |
| May 5, 2010 | K100187 | EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT Medica Corp. | CGA |
| Apr 6, 2010 | K100673 | EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 Medica Corp. | JGS |
| Nov 17, 2009 | K092737 | EASYRA MG REAGENT, MODEL 10220 Medica Corp. | JGJ |
| Sep 16, 2009 | K092506 | EASYRA GLU-H REAGENT, MODEL 10200 Medica Corp. | CFR |
| Sep 4, 2009 | K091991 | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 Medica Corp. | CIG |
| Jul 17, 2009 | K090734 | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES Medica Corp. | MRR |
| Mar 13, 2009 | K080404 | EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR Medica Corp. | JIX |
| Feb 20, 2009 | K080874 | EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT Medica Corp. | CIX |
| Dec 10, 2008 | K080810 | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT Medica Corp. | CIG |
| Nov 17, 2008 | K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT Medica Corp. | JFJ |
| Apr 14, 2008 | K073497 | HDL CHOLESTEROL REAGENT, MODEL 10211 Medica Corp. | LBS |
| Feb 20, 2008 | K072249 | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT Medica Corp. | CHH |
| Aug 30, 2007 | K070057 | EASYRA CLINICAL CHEMISTRY ANALYZER Medica Corp. | CGA |
| Jun 25, 2007 | K063376 | EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER Medica Corp. | CHL |
| Jul 16, 2002 | K021515 | EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER Medica Corp. | CHL |
| Feb 2, 2001 | K002407 | EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER Medica Corp. | JGS |
| May 15, 2000 | K000926 | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER Medica Corp. | CGZ |
| Nov 1, 1999 | K993034 | MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD Medica, Inc. | MVM |
| Apr 27, 1999 | K990971 | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 Medica Corp. | JJR |
| Feb 5, 1998 | K974526 | EASYBLOOD GAS ANALYZER Medica Corp. | CHL |
| Nov 29, 1996 | K963992 | CAPILLARY ADAPTOR ACCESSORY Medica Corp. | CGZ |
| Nov 29, 1996 | K963763 | EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER Medica Corp. | JGS |
| Nov 27, 1996 | K963694 | EASYLYTE CALCIUM/CHLORIDE ANALYZER Medica Corp. | JFP |
| Jun 21, 1996 | K961326 | EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER Medica Corp. | CEM |
| Feb 23, 1996 | K955375 | EASYSTAT SODIUM/POTASSIUM ANALYZER Medica Corp. | JGS |
| Feb 23, 1996 | K955374 | EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER Medica Corp. | JGS |
| Jan 17, 1995 | K943091 | EASY LYTE CALCIUM ANALYZER Medica Corp. | JFP |
| Dec 4, 1991 | K914810 | EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER Medica Corp. | JGS |
Newest 50 of 59.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Medica Corporation Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. Open, Classified |
CEM | K021515 |
| Feb 6, 2019 | Medica Corporation Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer
REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wa Terminated |
CHI | None listed |
| Nov 21, 2017 | Medica Corporation Wash Kit (REF 10680) Lots 16279, 17045 and 17215
Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution i Terminated |
CHI | None listed |
| Apr 11, 2017 | Medica Corporation EasyCAL HbA1c Calibrator; REF 10658
Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet. Terminated |
JIT | K120497 |
| Oct 18, 2010 | Medica Corporation EasyRA Cuvette Segment 1, P/N 007000-001
(In Vitro Diagnostic )
EasyRA Cuvette Segments included in the following Kits:
EasyRA Cuvettes, REF 10700-4
Startup Kit - Chemistry, REF 10990
Startup Kit - C Terminated |
JJE | K070057 K072249 |