Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Investor ABLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Laborie Medical Technologies Corp. with 18 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Aug 27, 2024: injeTAK Adjustable Tip Needle (DIS199; DIS201).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 27, 2024 | injeTAK Adjustable Tip Needle (DIS199; DIS201)K241523 · FBK | 510(k) clearances |
| May 6, 2024 | Solar Compact (G4-1)K240007 · FFX | 510(k) clearances |
| Apr 23, 2024 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)K234107 · KLA | 510(k) clearances |
| Jul 17, 2019 | U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctionsClass II · Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet a | Device recalls |
| Jul 21, 2009 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPK090830 · FBK | 510(k) clearances |
| Mar 6, 2009 | EVOX ELECTRO DIAGNOSTIC DEVICEK082614 · GWF | 510(k) clearances |
| Jul 9, 2008 | NUWAVK081781 · IYO | 510(k) clearances |
| Mar 5, 2008 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYK073552 · FEN | 510(k) clearances |
| May 4, 2007 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIESK070331 · KPI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
