Data / Medical devices / New Zealand / Adept Medical Ltd
Adept Medical Ltd: FDA-registered device maker in Auckland, New Zealand, 1 510(k) clearance
Adept Medical Ltd is registered with the FDA (registration 3006098219) in Auckland, New Zealand. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2006. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006098219
- Address
- 2-6 Mcdonald Street, Morningside, Auckland, New Zealand, 1025
- Owner or operator
- ADEPT MEDICAL LTD (9086027)
- Roles
- Manufacturer
- First device listed
- September 12, 2006
- Registered through
- 2026
- Brand names listed
- ADEPT MEDICAL CERUMEN HOOK, ADEPT MEDICAL CERUMEN MANAGEMENT KIT, ADEPT MEDICAL EAR SPECULA, ADEPT MEDICAL EAR SUCTION TUBE, ADEPT MEDICAL EAR SUCTION TUBES WITH SUCTION CONTROLLER, ADEPT MEDICAL MICRO EAR FORCEPS, ADEPT MEDICAL NASAL FORCEPS, ADEPT MEDICAL SUCTION CONTROLLER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Control Panel, X-Ray, Movable | IWX | 1 | Manufacturer | accessdata.fda.gov |
| Chair And Table, Medical | KMN | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Manufacturer | accessdata.fda.gov |
| Excavator, Ear | JYH | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Manufacturer | accessdata.fda.gov |
| Inserter, Myringotomy Tube | JYM | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Myringotomy | JYP | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Manufacturer | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tympanostomy | ETD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 12, 2006 | K061058 | NEOZOLINE VENTILATION TUBES | ETD | Substantially Equivalent | Adept Medical, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 24, 2024 | 95942 | Class II | Ongoing | Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2 | Lack of 510(k) clearance. | accessdata.fda.gov |
Compare with other makers
- All makers of Table And Attachments, Operating-Room
- All makers of Inserter, Myringotomy Tube
- All makers of Tray, Surgical, Instrument
- All makers of Knife, Myringotomy
- All makers of Curette, Ear
- All makers of Kit, Surgical Instrument, Disposable
Updated January 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.