Huntleigh Healthcare Ltd.
FDA Regulatory Profile
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 | February 11, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250777 | Sonicaid Team3 | September 19, 2025 |
| K241368 | Sonicaid Team3 | February 3, 2025 |
| K211200 | WoundExpress | September 3, 2021 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | September 6, 2019 |
| K152228 | Hydroven 12, Hydroven 12 Garments | April 4, 2016 |
| K121108 | DOPPLEX ABILITY | January 3, 2013 |
| K090285 | SONICAID FM820 AND FM830 ENCORE | July 15, 2009 |
| K081572 | SMARTSIGNS MINPULSE | October 1, 2008 |
| K060230 | DOPPLEX CENTRALE | March 23, 2006 |
| K053369 | MEDILOG DARWIN HOLTER ANALYSIS | December 22, 2005 |
| K032315 | IOP8 INTRA OPERATIVE PROBE | November 18, 2004 |
| K022786 | DVT60 | September 19, 2002 |
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | March 26, 2002 |
| K012008 | STS RANGE , MODELS STS20,STS30,STS40 | September 21, 2001 |
| K002186 | VASCULAR ASSIST | May 2, 2001 |
| K010894 | BABY DOPPLEX 3002 (BD3002) | April 25, 2001 |
| K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) | April 25, 2001 |
| K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 | September 19, 2000 |
| K990569 | BABY DOPPLEX 4000, MODEL BD 4000 | January 24, 2000 |
| K984307 | MODIFICATION OF: RHEO DOPPLEX II | January 12, 1999 |