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Acumedia Manufacturers, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
177
FDA recalls
8

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Acumedia Manufacturers, Inc. makes

Acumedia Manufacturers, Inc. produces microbiological culture media and transport media, including selective and differential agar plates, broths, and specialized mixtures for bacterial and fungal isolation, identification, and transport. Examples include bile salts mixtures, Sabouraud maltose agar, and Amies transport medium for clinical and laboratory use.

The company’s products are regulated under FDA’s Class I and Class II device classifications, with many authorised via the 510(k) pathway. These items are listed in the FDA’s 510(k) database and comply with U.S. medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue177

Newest first, rows 1-50 of 177

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  • Acu-Desoxycholate Agar Ref K811134

    Class I
    Active 510(k) 510(k) I

  • Thioglycollate Medium W/Out Indicator Ref K811340

    Class I
    Active 510(k) 510(k) I

  • Lactabacillus Agar W/O TWEEN80 Ref K833292

    Not classified
    Active 510(k) 510(k) —

  • Bile Salts Mixture Ref K833211

    Class I
    Active 510(k) 510(k) I

  • Eugon Broth Ref K811132

    Class I
    Active 510(k) 510(k) I

  • Amies Transport Medium Ref K881539

    Class I
    Active 510(k) 510(k) I

  • Tech Agar Ref K833206

    Class I
    Active 510(k) 510(k) I

  • Brain Heart Cc Agar Ref K811332

    Class I
    Active 510(k) 510(k) I

  • Kligler Iron Agar Ref K833213

    Class I
    Active 510(k) 510(k) I

  • Sabouraud Maltose Agar Ref K881570

    Class I
    Active 510(k) 510(k) I

  • Trichomonas Broth Ref K881556

    Class I
    Active 510(k) 510(k) I

  • Baird-Parker Agar Ref K811038

    Class I
    Active 510(k) 510(k) I

  • Brain Heart Infusion Ref K811056

    Class I
    Active 510(k) 510(k) I

  • Deoxycholate Citrate Agar Ref K833204

    Class I
    Active 510(k) 510(k) I

  • Thiotone Peptone Ref K811732

    Class I
    Active 510(k) 510(k) I

  • Violet Red Bile Agar Ref K811338

    Class I
    Active 510(k) 510(k) I

  • Modified Selective Streptococcus Agar Ref K881577

    Class I
    Active 510(k) 510(k) I

  • Gelatin Ref K881541

    Class I
    Active 510(k) 510(k) I

  • Hektoen Enteric Agar Ref K811131

    Class I
    Active 510(k) 510(k) I

  • Agar, Bacteriological Ref K811359

    Class I
    Active 510(k) 510(k) I

  • Tryptose Agar Ref K881558

    Class I
    Active 510(k) 510(k) I

  • Tcbs Agar Ref K811362

    Class I
    Active 510(k) 510(k) I

  • W-L Differential Medium Ref K881574

    Class I
    Active 510(k) 510(k) I

  • Biosate Ref K811730

    Class I
    Active 510(k) 510(k) I

  • Flo Agar Ref K881540

    Class I
    Active 510(k) 510(k) I

  • Of Basal Medium Ref K881550

    Class I
    Active 510(k) 510(k) I

  • Dextrose Broth Ref K811731

    Class I
    Active 510(k) 510(k) I

  • Antibiotic Medium #5 Streptomycin Assay Agar Ref K881536

    Class I
    Active 510(k) 510(k) I

  • Biggy Agar Ref K811054

    Class I
    Active 510(k) 510(k) I

  • Malt Extract Agar Ref K881546

    Class I
    Active 510(k) 510(k) I

  • Feeley-Gorman Agar Ref K833301

    Class I
    Active 510(k) 510(k) I

  • Urea Agar Base Ref K881559

    Class I
    Active 510(k) 510(k) I

  • Lauryl Sulfate Broth Ref K811129

    Class I
    Active 510(k) 510(k) I

  • Schaedler Broth Ref K811329

    Class I
    Active 510(k) 510(k) I

  • Gc Agar Ref K811053

    Class II
    Active 510(k) 510(k) II

  • Gelysate Ref K811649

    Class I
    Active 510(k) 510(k) I

  • Dnase Test Agar Ref K881486

    Class I
    Active 510(k) 510(k) I

  • Amies Transport Medium W/O Charcoal Ref K881579

    Class I
    Active 510(k) 510(k) I

  • Dehydrated Bile Ref K811358

    Class II
    Active 510(k) 510(k) II

  • Mph Agar Ref K881548

    Class I
    Active 510(k) 510(k) I

  • Middlebrook & Cohn 7H10 Agar Base Ref K834205

    Class I
    Active 510(k) 510(k) I

  • Schaedler Agar Ref K811328

    Class I
    Active 510(k) 510(k) I

  • Malt Extract Ref K881545

    Class I
    Active 510(k) 510(k) I

  • Fluid Thioglycollate Medium Ref K811047

    Class I
    Active 510(k) 510(k) I

  • Cetrimede Agar Ref K811040

    Class I
    Active 510(k) 510(k) I

  • Wilkens Chalgren Agar Ref K881567

    Class II
    Active 510(k) 510(k) II

  • Wilkens Chalgren Broth Ref K881568

    Class II
    Active 510(k) 510(k) II

  • Blood Agar Base Ph 7.4 Ref K811055

    Class I
    Active 510(k) 510(k) I

  • Tergitol 7 Agar Ref K811337

    Class I
    Active 510(k) 510(k) I

  • Mac Conkey Agar Without Crystal Violet Ref K833212

    Class I
    Active 510(k) 510(k) I

Rows 1-50 of 177

Showing 1-50 of 177

FDA recalls8

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 8 recalls initiated by Acumedia Manufacturers, Inc., the earliest on 2015-09-11 and the most recent on 2018-08-02. By recorded status: 8 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 2
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

6 initiated before 2017

  • 2018

    • 2 Aug 2018 Z-0283-2019 Class III Terminated Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021. Distribution: Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico,…
      Full distribution text Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.
    • 2 Aug 2018 Z-0284-2019 Class III Terminated The product is labeled with an incorrect expiration date. Distribution: US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.

  • 2016

    • 25 Sep 2016 Z-2221-2017 Class III Terminated Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. Distribution: Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
    • 8 Aug 2016 Z-2212-2017 Class III Terminated Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. Distribution: US in the state of IL
    • 22 Apr 2016 Z-1093-2017 Class II Terminated light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts. Distribution: Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH,…
      Full distribution text Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
    • 23 Mar 2016 Z-2213-2017 Class III Terminated Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018. Distribution: Worldwide - US Nationwide in the state of ME; in the country of ECUADOR

  • 2015

    • 30 Nov 2015 Z-2584-2017 Class II Terminated Contamination of product with possible Bacillus spp Distribution: Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
    • 11 Sep 2015 Z-2214-2017 Class III Terminated Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019. Distribution: Worldwide - US Nationwide in the state IL and the country of COLOMBIA

Frequently asked questions

How many devices does Acumedia Manufacturers, Inc. have in the registry?

The registry currently lists 177 devices for Acumedia Manufacturers, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Acumedia Manufacturers, Inc.'s devices?

Among its 50 most recently registered devices, Acumedia Manufacturers, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Acumedia Manufacturers, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Acumedia Manufacturers, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Acumedia Manufacturers, Inc.?

FDA recall records list 8 recalls initiated by Acumedia Manufacturers, Inc., the most recent initiated on 2018-08-02. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Acumedia Manufacturers, Inc. in the registry?

The most recently registered devices listed for Acumedia Manufacturers, Inc. include ACU-DESOXYCHOLATE AGAR, THIOGLYCOLLATE MEDIUM W/OUT INDICATOR, LACTABACILLUS AGAR W/O TWEEN80 and BILE SALTS MIXTURE.

Generated automatically from registry data and not verified by a human reviewer.