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Acumed LLC

Active in EUDAMED
Also registered as Acu Med, Inc.

United Statesfrom SRN EUDAMED FDA SRN US-MF-000023121 FEI 1000125930

Devices
7,426
Registrations
EUDAMEDFDA
FDA recalls
517 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

What Acumed LLC makes

Acumed LLC manufactures orthopaedic bone screws, non-bioabsorbable fixation plates, and general internal orthopaedic fixation system implantation kits. The company also produces reusable bone taps and various sterile and non-sterile internal fixation systems consisting of plate and screw combinations.

The company is based in the United States, and its portfolio of Class I and Class II medical devices is listed in the FDA UDI database.

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

Catalogue7,426

Newest first, rows 1-50 of 7,426

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  • Acumed Ref 3025-35028-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 80-3923

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 3013-27014-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref PL-SR37

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 218-0084-SP

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 7108-0103

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 80-2707

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 7107-0602

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 3025-35040-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 3050-20030-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 3013-35028-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 80-3935

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 10100053

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 7107-0603

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 3013-35036-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 3050-20018-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 7107-0113L

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 10100060

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 3013-35060-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 3013-27038-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 80-3925

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 3050-20009-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 3013-27032-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 80-4043

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 80-4209-S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Acumed Ref 218-0089-SP

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 218-1605-SP-02

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 80-3784

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref MS-0622

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 80-3921

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 80-4001

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 7107-0205L

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 7108-0105

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 3025-35064-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 3025-35030-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 7107-0203R

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 3025-35044-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 218-0085-SP

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 80-4042

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 80-4188

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref MS-0621

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 7107-0403R

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 80-3964

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref MS-0001

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref 3014-23036-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 3025-35056-S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref 80-3961

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • Acumed Ref RBL2311

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Acumed Ref MS-0620

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Acumed Ref 7107-0703

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

Rows 1-50 of 7,426

Showing 1-50 of 7,426

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000023121
FDA FEI number
1000125930
EUDAMED status
Active
EUDAMED registered name
Acumed LLC
EUDAMED abbreviated name
Acumed
Registered address
5885 NE Cornelius Pass Road, 97124, Hillsboro, United States
PRRC contact
Kathryn Jayne(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 24 Jan 2028

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 739676 Active Amended

    Technical documentation EU MDR

    Issued
    26 Aug 2025
    Expires
    24 Jan 2028
    Reason
    Ar data change

FDA recalls51

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 51 recalls initiated by ACUMED LLC, the earliest on 2005-12-27 and the most recent on 2026-05-28. By recorded status: 7 ongoing, 42 terminated and 2 with another status. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. 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 3
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 6
  • 2023 2
  • 2024 0
  • 2025 0
  • 2026 1

39 initiated before 2017

Showing the 10 most recent of 51 recalls.

  • 2026

    • 28 May 2026 Z-2532-2026 Class II Ongoing Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. Distribution: US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI.
      Submission numbers: K251132, K251296

  • 2023

    • 19 Dec 2023 Z-1218-2024 Class II Ongoing Distribution without Pre-Market Clearance Distribution: Worldwide distribution - US Nationwide and the countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, ID, IE, IL, IT, JP, KR, KW, MX, MY, NZ, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, US, ZA.
    • 27 Nov 2023 Z-0618-2024 Class II Ongoing Due to potential breakage during use. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NJ, OH, OR, SC, TX, UT, VA, WA, and WI. The country of Australia.

  • 2022

    • 29 Nov 2022 Z-0767-2023 Class II Ongoing Distribution without Pre-Market Clearance Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
      Submission number: K221333
    • 29 Nov 2022 Z-0768-2023 Class II Ongoing Distribution without Pre-Market Clearance Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
      Submission number: K221333
    • 29 Nov 2022 Z-0769-2023 Class II Ongoing Distribution without Pre-Market Clearance Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
      Submission number: K221333
    • 29 Nov 2022 Z-0770-2023 Class II Ongoing Distribution without Pre-Market Clearance Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
      Submission number: K221333
    • 9 Mar 2022 Z-0958-2022 Class II Completed Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage. Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.
      Submission number: K123890
    • 9 Mar 2022 Z-0959-2022 Class II Completed Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage. Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.
      Submission number: K123890

  • 2017

    • 20 Apr 2017 Z-2197-2017 Class II Terminated The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations. Distribution: US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC,…
      Full distribution text US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico.
      Submission number: K131845
Show the 25 most recent of 51 recalls

  • 2017

    • 17 Feb 2017 Z-1483-2017 Class II Terminated Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks). Distribution: Worldwide Distribution in Great Britain, Ireland, and Japan only.
    • 19 Jan 2017 Z-1199-2017 Class II Terminated The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed. Distribution: Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain Submission number: K122538

  • 2016

    • 5 Dec 2016 Z-1019-2017 Class II Terminated OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification. Distribution: distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico. Submission number: K042340

  • 2014

    • 26 Mar 2014 Z-1515-2014 Class II Terminated Manufacturing of these devices with a grade of stainless steel that is not within specifications. Distribution: US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY.…
      Full distribution text US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
      Submission number: K964500
    • 26 Mar 2014 Z-1516-2014 Class II Terminated Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications. Distribution: US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY.…
      Full distribution text US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
      Submission number: K931244

  • 2012

    • 7 Mar 2012 Z-1357-2012 Not yet classified Terminated The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain. Submission number: K951740

  • 2010

    • 14 Apr 2010 Z-1807-2010 Unclassified (pre-2012) Terminated The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union. Distribution: Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada,…
      Full distribution text Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada, Turkey, Ireland, Finland, Belgium, Australia, Germany, and Sweden.
      Submission number: K012655

  • 2009

    • 21 Aug 2009 Z-0073-2010 Unclassified (pre-2012) Terminated Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385). Distribution: Worldwide Distribution -- USA and South Africa. Submission number: K061763
    • 19 May 2009 Z-1602-2010 Unclassified (pre-2012) Terminated Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw Distribution: Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea,…
      Full distribution text Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan
      Submission number: K942340

  • 2008

    • 21 Aug 2008 Z-1552-2010 Unclassified (pre-2012) Terminated Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material. Distribution: Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South…
      Full distribution text Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South Africa.
      Submission number: K031438
    • 9 Jul 2008 Z-1154-2010 Unclassified (pre-2012) Terminated Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw. Distribution: Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and…
      Full distribution text Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece.
      Submission number: K965029
    • 13 May 2008 Z-0447-2009 Unclassified (pre-2012) Terminated The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated. Distribution: World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South…
      Full distribution text World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain.
      Submission number: K992525
    • 28 Mar 2008 Z-2140-2008 Unclassified (pre-2012) Terminated Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping. Distribution: Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN. Submission number: K921480
    • 14 Feb 2008 Z-2108-2008 Unclassified (pre-2012) Terminated Product sterility may be compromised. Distribution: Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and…
      Full distribution text Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and countries of United Kingdom, Australia, and Greece.
      Submission number: K033639
    • 14 Feb 2008 Z-2109-2008 Unclassified (pre-2012) Terminated Product sterility may be compromised. Distribution: Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and…
      Full distribution text Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and countries of United Kingdom, Australia, and Greece.
      Submission number: K033639

Frequently asked questions

How many devices does ACUMED LLC have in the registry?

The registry currently lists 7426 devices for ACUMED LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list ACUMED LLC's devices?

Among its 50 most recently registered devices, ACUMED LLC has devices listed in EUDAMED (50 devices).

What risk classes do ACUMED LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for ACUMED LLC's devices are Class I, Class IIa and Class IIb. Each device page shows its own class and authorisation.

Are there FDA recall records for ACUMED LLC?

FDA recall records list 51 recalls initiated by ACUMED LLC, the most recent initiated on 28 May 2026. 7 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for ACUMED LLC?

EUDAMED lists 1 certificate for ACUMED LLC (technical documentation) under MDR. The most recent was issued on 26 Aug 2025.

What are the newest devices from ACUMED LLC in the registry?

The most recently registered devices listed for ACUMED LLC include Acumed.

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