Huntleigh Healthcare Ltd.
FDA Regulatory Profile
Huntleigh Healthcare Ltd. appears in FDA public data with 1 recall, 24 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0960-2022, Class II) was initiated on Feb 11, 2022. Its most recent 510(k) clearance was granted on Sep 19, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 24
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0960-2022 | Class II | HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposab | Feb 11, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250777 | Sonicaid Team3 | Sep 19, 2025 |
| K241368 | Sonicaid Team3 | Feb 3, 2025 |
| K211200 | WoundExpress | Sep 3, 2021 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Sep 6, 2019 |
| K152228 | Hydroven 12, Hydroven 12 Garments | Apr 4, 2016 |
| K121108 | DOPPLEX ABILITY | Jan 3, 2013 |
| K090285 | SONICAID FM820 AND FM830 ENCORE | Jul 15, 2009 |
| K081572 | SMARTSIGNS MINPULSE | Oct 1, 2008 |
| K060230 | DOPPLEX CENTRALE | Mar 23, 2006 |
| K053369 | MEDILOG DARWIN HOLTER ANALYSIS | Dec 22, 2005 |
| K032315 | IOP8 INTRA OPERATIVE PROBE | Nov 18, 2004 |
| K022786 | DVT60 | Sep 19, 2002 |
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | Mar 26, 2002 |
| K012008 | STS RANGE , MODELS STS20,STS30,STS40 | Sep 21, 2001 |
| K002186 | VASCULAR ASSIST | May 2, 2001 |
| K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) | Apr 25, 2001 |
| K010894 | BABY DOPPLEX 3002 (BD3002) | Apr 25, 2001 |
| K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 | Sep 19, 2000 |
| K990569 | BABY DOPPLEX 4000, MODEL BD 4000 | Jan 24, 2000 |
| K984307 | MODIFICATION OF: RHEO DOPPLEX II | Jan 12, 1999 |