Riverpoint Medical, LLC
Portland, OR, US
RIVERPOINT MEDICAL LLC appears in FDA device records in Portland, OR. FDA records list 38 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 47 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Riverpoint Medical, LLC between 2009 and 2026. The busiest year on record is 2024, with 9. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2023 | 8 |
| 2024 | 9 |
| 2025 | 4 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253693 | Strut Suture; No-Tie Button | MBI | Substantially Equivalent | |
| K253695 | LigaMend | MBI | Substantially Equivalent | |
| K253024 | ProZip Knotless Implant | GAT | Substantially Equivalent | |
| K252201 | HS Fiber | GAT | Substantially Equivalent | |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ Anchor | MBI | Substantially Equivalent | |
| K243988 | RootMend MRR | MBI | Substantially Equivalent | |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | MBI | Substantially Equivalent | |
| K243323 | Iconix Knotless Anchor | MBI | Substantially Equivalent | |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | MBI | Substantially Equivalent | |
| K241282 | RibFix Titan™ Fixation System | HRS | Substantially Equivalent | |
| K241577 | Iconix® Anchor | MBI | Substantially Equivalent | |
| K240719 | OC JuggerKnot Soft Anchor | MBI | Substantially Equivalent | |
| K240213 | Iconix Knotless Anchor | MBI | Substantially Equivalent | |
| K240194 | ProCinch, QuadCinch | MBI | Substantially Equivalent | |
| K231163 | HS Fiber Sutures | GAT | Substantially Equivalent | |
| K233552 | IDEAL Ziploop | MBI | Substantially Equivalent | |
| K233468 | Iconix Anchor | MBI | Substantially Equivalent | |
| K232411 | JuggerKnot Soft Anchor OC | MBI | Substantially Equivalent | |
| K231078 | All-Suture Anchor | MBI | Substantially Equivalent | |
| K231278 | Knotless Suture Anchor | MBI | Substantially Equivalent | |
| K220765 | HS Fiber Cerclage | JDQ | Substantially Equivalent | |
| K231128 | JuggerKnot Soft Anchor | MBI | Substantially Equivalent | |
| K230212 | OrthoButton AL | MBI | Substantially Equivalent | |
| K203740 | JuggerKnot Soft Anchor | MBI | Substantially Equivalent | |
| K202399 | OrthoButton FL | MBI | Substantially Equivalent | |
| K202242 | HS Fiber | GAT | Substantially Equivalent | |
| K190817 | HS Fiber | GAT | Substantially Equivalent | |
| K171060 | OrthoButton AL | MBI | Substantially Equivalent | |
| K160655 | OrthoButton CL | MBI | Substantially Equivalent | |
| K153307 | HS SutureTape | GAT | Substantially Equivalent | |
| K152795 | RiverLon (Nylon) Suture | GAR | Substantially Equivalent | |
| K150288 | PDO Absorbable Punctum Plug | LZU | Substantially Equivalent | |
| K140415 | MONOTEX | NBY | Substantially Equivalent | |
| K120556 | VILET VILET QUICK | GAM | Substantially Equivalent | |
| K103449 | BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS | KXK | Substantially Equivalent | |
| K100461 | PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT | NEW | Substantially Equivalent | |
| K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED | GAT | Substantially Equivalent | |
| K092059 | RP CUTTING NEEDLE | KNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006981798 | 3006981798 | RIVERPOINT MEDICAL LLC | 825 NE 25th Ave, Portland, OR 97232 US | 2026 | and 19 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- HTWBit, Drill
- JDQCerclage, Fixation
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HPPHeadlamp, Operating, Battery-Operated
- KNWInstrument, Biopsy
- HJHLoupe, Binocular, Low Power
- NEUMarker, Radiographic, Implantable
- OJHOrthopedic Tray
- HWQPasser
- HRSPlate, Fixation, Bone
- LZUPlug, Punctum
- KGSRetention Device, Suture
- KXKSource, Brachytherapy, Radionuclide
- OVNSuture Kit
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- NEWSuture, Surgical, Absorbable, Polydioxanone
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- IWJSystem, Applicator, Radionuclide, Manual
- EXMTruss, Umbilical
- HTNWasher, Bolt Nut
- MTJWax, Bone
Recall records
Showing 25 of 47| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0518-2024 | 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 bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. | 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. | Class II | Open, Classified | |
| Z-0949-2021 | 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. | Class II | Terminated | |
| Z-0049-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0048-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0047-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0046-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0045-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0044-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0043-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0042-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0041-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0040-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0039-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0038-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0037-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0036-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0035-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0034-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0033-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0032-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0031-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0030-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0029-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0028-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated | |
| Z-0027-2021 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain