Laborie Medical Technologies Corp
FDA Regulatory Profile
Laborie Medical Technologies Corp appears in FDA public data with 2 recalls, 18 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2669-2026, Class II) was initiated on May 21, 2026. Its most recent 510(k) clearance was granted on August 27, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 18
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2669-2026 | Class II | Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley s | May 21, 2026 |
| Z-2076-2019 | Class II | U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing l | July 17, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | August 27, 2024 |
| K240007 | Solar Compact (G4-1) | May 6, 2024 |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | April 23, 2024 |
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | July 21, 2009 |
| K082614 | EVOX ELECTRO DIAGNOSTIC DEVICE | March 6, 2009 |
| K081781 | NUWAV | July 9, 2008 |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | March 5, 2008 |
| K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES | May 4, 2007 |
| K962009 | UROSTYM | May 20, 1997 |
| K955856 | TEX-AID BLUE | February 16, 1996 |
| K955810 | U-TEX | January 24, 1996 |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | July 6, 1995 |
| K942563 | ELITE BIOFEEDBACK | June 6, 1995 |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | July 12, 1994 |
| K934369 | DRI SLEEPER | November 24, 1993 |
| K931574 | ADVANCE MODEL UDS-ADV | August 5, 1993 |
| K930005 | DRITRAINER | March 3, 1993 |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | October 20, 1992 |