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Sign in to claim this brandACUMED LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 5885 NE Cornelius Pass Rd, Hillsboro, OR, 97124
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000125930
- DUNS Number
- —
Catalogue (6937)
Page 138 of 139| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acumed | 80-1533 | FDA UDI | Class I | Active |
| Acumed | MS-PH46 | FDA UDI | Class I | Active |
| Acumed | 80-0661 | FDA UDI | Class I | Active |
| Acupuncture Needle Pack | K960769 | FDA 510(k) | Class II | Active |
| Oregon Fixation Screw | K910976 | FDA 510(k) | Class II | Active |
| Acumed Wrist Spanning Plate | K131764 | FDA 510(k) | Class II | Active |
| Bone Plate | K931244 | FDA 510(k) | Class II | Active |
| Acutract | K930834 | FDA 510(k) | Class II | Active |
| Acumed Anatomic Radial Head System | K041858 | FDA 510(k) | Class II | Active |
| Polarus Cap Screw | K013616 | FDA 510(k) | Class II | Active |
| Cortical Bone Screw | K942340 | FDA 510(k) | Class II | Active |
| Bone Anchor | K942787 | FDA 510(k) | Class II | Active |
| Acumed Ankle Syndesmosis Repair System | K212990 | FDA 510(k) | Class II | Active |
| Cerclage Wire Crimp Sleeve | K931246 | FDA 510(k) | Class II | Active |
| Cannulated Cancellous Bone Screw | K942341 | FDA 510(k) | Class II | Active |
| Wrist Fusion Plate | K021321 | FDA 510(k) | Class II | Active |
| Acumed Clavicle Hook Plating System | K210750 | FDA 510(k) | Class II | Active |
| Acumed Acutrak 3 Headless Compression Screw System | K230744 | FDA 510(k) | Class II | Active |
| Acumed Suture Anchor | K993657 | FDA 510(k) | Class II | Active |
| Congruent Bone Plate System | K102998 | FDA 510(k) | Class II | Active |
| Acumed Suture Anchor | K980103 | FDA 510(k) | Class II | Active |
| Polarus Af Rod | K962091 | FDA 510(k) | Class II | Active |
| Congruent Bone Plate System | K012655 | FDA 510(k) | Class II | Active |
| Oregon Fixation System Interference Screw | K932027 | FDA 510(k) | Class II | Active |
| External Fixator | K943857 | FDA 510(k) | Class II | Active |
| Acumed Bone Graft System | K960711 | FDA 510(k) | Class I | Active |
| Acumed Ankle Plating System | K143385 | FDA 510(k) | Class II | Active |
| Intramedulary Fixation Rod | K920666 | FDA 510(k) | Class II | Active |
| Acumed Modular Shoulder System | K992525 | FDA 510(k) | Class II | Active |
| Acumed Suture Washer | K965028 | FDA 510(k) | Class II | Active |
| The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | K251132 | FDA 510(k) | Class II | Active |
| Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc | K131845 | FDA 510(k) | Class II | Active |
| Suture Washer | K954148 | FDA 510(k) | Class II | Active |
| Acumed Congruent Bone Plate System | K071715 | FDA 510(k) | Class II | Active |
| Acumed Hand Fracture System | K141383 | FDA 510(k) | Class II | Active |
| Wyman Suture Washer | K910186 | FDA 510(k) | Class II | Active |
| Acufit Total Hip | K904383 | FDA 510(k) | Class II | Active |
| Slic Screw Repair System | K111608 | FDA 510(k) | Class II | Active |
| Acu-Sinch Repair System And Acumed Suture Anchor | K112111 | FDA 510(k) | Class II | Active |
| Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | K221333 | FDA 510(k) | Class II | Active |
| Acumed Pelvic Bone Plate System | K122538 | FDA 510(k) | Class II | Active |
| Acumed Tension Band Pin | K964500 | FDA 510(k) | Class II | Active |
| Polarus Connect | K131636 | FDA 510(k) | Class II | Active |
| Acumed Flexible Cannula | K932099 | FDA 510(k) | Class II | Active |
| Acumed Small Bone Locking System Ii | K071944 | FDA 510(k) | Class II | Active |
| Stableloc Ii External Fixator | K965029 | FDA 510(k) | Class II | Active |
| Cerclage Wire Crimp Block | K960651 | FDA 510(k) | Class II | Active |
| Acumed Cannulated Screw System | K123890 | FDA 510(k) | Class II | Active |
| Acumed Suture Anchor System | K140925 | FDA 510(k) | Class II | Active |
| The Acumed Wrist Fixation System | K251296 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (50)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 19, 2023 | Z-1218-2024 | — | open, classified | Distribution without Pre-Market Clearance |
| Nov 27, 2023 | Z-0618-2024 | — | open, classified | Due to potential breakage during use. |
| Nov 29, 2022 | Z-0769-2023 | — | open, classified | Distribution without Pre-Market Clearance |
| Nov 29, 2022 | Z-0767-2023 | — | open, classified | Distribution without Pre-Market Clearance |
| Nov 29, 2022 | Z-0768-2023 | — | open, classified | Distribution without Pre-Market Clearance |
| Nov 29, 2022 | Z-0770-2023 | — | open, classified | Distribution without Pre-Market Clearance |
| Mar 9, 2022 | Z-0959-2022 | — | 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. |
| Mar 9, 2022 | Z-0958-2022 | — | 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. |
| Apr 20, 2017 | Z-2197-2017 | — | 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. |
| Feb 17, 2017 | Z-1483-2017 | — | 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). |
| Jan 19, 2017 | Z-1199-2017 | — | 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. |
| Dec 5, 2016 | Z-1019-2017 | — | 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. |
| Mar 26, 2014 | Z-1515-2014 | — | terminated | Manufacturing of these devices with a grade of stainless steel that is not within specifications. |
| Mar 26, 2014 | Z-1516-2014 | — | 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. |
| Mar 7, 2012 | Z-1357-2012 | — | terminated | The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates. |
| Apr 14, 2010 | Z-1807-2010 | — | 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. |
| Aug 21, 2009 | Z-0073-2010 | — | 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). |
| May 19, 2009 | Z-1602-2010 | — | terminated | Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw |
| Aug 21, 2008 | Z-1552-2010 | — | terminated | Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material. |
| Jul 9, 2008 | Z-1154-2010 | — | 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. |
| May 13, 2008 | Z-0447-2009 | — | 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. |
| Mar 28, 2008 | Z-2140-2008 | — | terminated | Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping. |
| Feb 14, 2008 | Z-2127-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2110-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2112-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2131-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2130-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2111-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2128-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2114-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2119-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2129-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2115-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2108-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2126-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2120-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2124-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2121-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2123-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2113-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2125-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2117-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2122-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2118-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2109-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2116-2008 | — | terminated | Product sterility may be compromised. |
| Feb 14, 2008 | Z-2132-2008 | — | terminated | Product sterility may be compromised. |
| Jul 9, 2007 | Z-2135-2008 | — | terminated | Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly. |
| Jun 29, 2007 | Z-2153-2008 | — | terminated | Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L. |
| Dec 27, 2005 | Z-2155-2008 | — | terminated | Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw. |