Data / Medical devices / United States / Riverpoint Medical LLC
Riverpoint Medical LLC: FDA-registered device maker in Portland, OR, United States, 45 510(k) clearances
Riverpoint Medical LLC is registered with the FDA (registration 3006981798) in Portland, OR, United States. It lists 29 device types. The FDA files 45 510(k) clearances under its listings, the newest dated March 11, 2026. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006981798
- Address
- 825 NE 25th Ave, Portland, OR, United States, 97232
- Owner or operator
- Riverpoint Medical LLC (10024181)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- January 9, 2008
- Registered through
- 2027
- Brand names listed
- Applicator Needle, Applicator Needles, BONE WAX, Brachytherapy Needles, C-PTFE Surgical Suture, CP COTTON UMBILICAL TAPE, CP-FIBER; ORTHOFIBER; POWERFIBER, CP-Fiber, PowerFiber (Polyethylene suture) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Headlamp, Operating, Battery-Operated | HPP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Loupe, Binocular, Low Power | HJH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Passer | HWQ | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Manufacturer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Source, Brachytherapy, Radionuclide | KXK | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Suture Kit | OVN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt | PTX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Truss, Umbilical | EXM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wax, Bone | MTJ | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 11, 2026 | K253693 | Strut Suture; No-Tie Button | MBI | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| February 27, 2026 | K253695 | LigaMend | MBI | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| October 16, 2025 | K253024 | ProZip Knotless Implant | GAT | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| August 13, 2025 | K252201 | HS Fiber | GAT | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| July 30, 2025 | K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| March 20, 2025 | K243988 | RootMend MRR | MBI | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| November 19, 2024 | K243323 | Iconix Knotless Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| October 29, 2024 | K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| August 19, 2024 | K241282 | RibFix Titan Fixation System | HRS | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| July 3, 2024 | K241577 | Iconix® Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| April 11, 2024 | K240719 | OC JuggerKnot Soft Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| February 23, 2024 | K240213 | Iconix Knotless Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| February 21, 2024 | K240194 | ProCinch, QuadCinch | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| November 30, 2023 | K233552 | IDEAL Ziploop | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| November 14, 2023 | K233468 | Iconix Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| October 6, 2023 | K232411 | JuggerKnot Soft Anchor OC | MBI | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| August 1, 2023 | K231278 | Knotless Suture Anchor | MBI | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| May 17, 2023 | K231128 | JuggerKnot Soft Anchor | MBI | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| February 23, 2023 | K230212 | OrthoButton AL | MBI | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| February 12, 2021 | K203740 | JuggerKnot Soft Anchor | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| September 18, 2020 | K202399 | OrthoButton FL | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| September 10, 2020 | K202242 | HS Fiber | GAT | Substantially Equivalent | Riverpoint Medical, LLC | accessdata.fda.gov |
| May 1, 2019 | K190817 | HS Fiber | GAT | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| March 26, 2018 | K173922 | C-PTFETM Surgical Suture | NBY | Substantially Equivalent | Cp Medical, Inc. | accessdata.fda.gov |
| June 2, 2017 | K171060 | OrthoButton AL | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| June 3, 2016 | K160655 | OrthoButton CL | MBI | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| February 12, 2016 | K153307 | HS SutureTape | GAT | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| October 28, 2015 | K152795 | RiverLon (Nylon) Suture | GAR | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| August 28, 2015 | K150288 | PDO Absorbable Punctum Plug | LZU | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| March 26, 2014 | K140415 | MONOTEX | NBY | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| May 23, 2012 | K120556 | VILET VILET QUICK | GAM | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| February 25, 2011 | K103449 | BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS | KXK | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| July 8, 2010 | K100461 | PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT | NEW | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| May 10, 2010 | K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED | GAT | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| March 18, 2010 | K094028 | CP-FIBER (ORTHOFIBER) | GAT | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| September 24, 2009 | K092059 | RP CUTTING NEEDLE | KNW | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| October 5, 2007 | K072229 | MONOSWIFT | GAM | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| September 17, 2004 | K041894 | ORTHOFIBER | GAT | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| June 19, 2003 | K024372 | CP MEDICAL BONE WAX | MTJ | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| March 28, 2003 | K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | GAQ | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| August 10, 2000 | K002190 | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) | GAM | Substantially Equivalent for Some Indications | Cp Medical | accessdata.fda.gov |
| June 23, 2000 | K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP | GAW | Substantially Equivalent for Some Indications | Cp Medical | accessdata.fda.gov |
| June 23, 2000 | K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | GAP | Substantially Equivalent for Some Indications | Cp Medical | accessdata.fda.gov |
| June 23, 2000 | K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP | GAR | Substantially Equivalent for Some Indications | Cp Medical | accessdata.fda.gov |
| June 23, 2000 | K001172 | POLYESTER NONABSORBABLE SURGICAL SUTURES URP | GAT | Substantially Equivalent for Some Indications | Cp Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 25, 2023 | 93390 | Class II | Ongoing | Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bo | Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use. | accessdata.fda.gov |
| December 9, 2020 | 87036 | Class II | Terminated | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 | Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence. | accessdata.fda.gov |
| August 3, 2020 | 86254 | Class II | Terminated | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | accessdata.fda.gov |
| February 8, 2019 | 84528 | Class II | Terminated | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR. | The integrity of the sterile grid packaging is potentially compromised. | accessdata.fda.gov |
| January 9, 2018 | 81935 | Class III | Terminated | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. | Product is labeled with "CE", but is not yet approved in the European Union. | accessdata.fda.gov |
| August 5, 2016 | 74891 | Class II | Terminated | Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation an | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. | accessdata.fda.gov |
| December 13, 2012 | 65584 | Class II | Terminated | Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue a | Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture. | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- All makers of Retention Device, Suture
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Suture, Surgical, Absorbable, Polydioxanone
Updated March 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.