510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Adept Medical Ltd

Auckland, NZ

ADEPT MEDICAL LTD appears in FDA device records in Auckland, NZ. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
8
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Adept Medical Ltd in 2006.

Clearances by year, as a table
510(k) clearance decisions for Adept Medical Ltd, by decision year
YearClearances
20061
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K061058NEOZOLINE VENTILATION TUBESETDSubstantially Equivalent

Registered establishments

FDA registered establishments for Adept Medical Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30060982193006098219ADEPT MEDICAL LTD2-6 MCDONALD STREET, MORNINGSIDE, AUCKLAND 1025 NZ2026and 4 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0970-2025Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;Lack of 510(k) clearance.Class IIOpen, Classified
Z-0969-2025Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;Lack of 510(k) clearance.Class IIOpen, Classified
Z-0968-2025Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;Lack of 510(k) clearance.Class IIOpen, Classified
Z-0967-2025Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;Lack of 510(k) clearance.Class IIOpen, Classified
Z-0966-2025Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;Lack of 510(k) clearance.Class IIOpen, Classified
Z-0965-2025Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;Lack of 510(k) clearance.Class IIOpen, Classified
Z-0964-2025Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;Lack of 510(k) clearance.Class IIOpen, Classified
Z-0963-2025Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;Lack of 510(k) clearance.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Adept Medical Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain