NEOZOLINE VENTILATION TUBES
ADEPT MEDICAL LTD
ADEPT MEDICAL LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006098219 | 3006098219 | ADEPT MEDICAL LTD | 1 | N | 2026-01-01 | 2-6 MCDONALD STREET, MORNINGSIDE AUCKLAND NZ 1025 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 66604 | 1104355517 | K061058 | NEOZOLINE VENTILATION TUBES | ETD | 2006-07-12 |
| 66604 | 1130181225 | ||||
| 66604 | 1284239265 | ||||
| 66604 | 1759676686 | ||||
| 66604 | 1820996522 | ||||
| 66604 | 1859657964 | ||||
| 66604 | 2045520997 | ||||
| 66604 | 1007315611 | ||||
| 66604 | 1197493991 | ||||
| 66604 | 1242056191 | ||||
| 66604 | 1302829599 | ||||
| 66604 | 1312165532 | ||||
| 66604 | 1328838729 | ||||
| 66604 | 1354315939 | ||||
| 66604 | 1520499088 | ||||
| 66604 | 1638437963 | ||||
| 66604 | 1693187808 | ||||
| 66604 | 1720045219 | ||||
| 66604 | 1790549152 | ||||
| 66604 | 1835492514 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| ETD | 1 | 2006-07-12 |
PMN#
ADEPT ULTRALITE 532 LASER
ADEPT MEDICAL CONCEPTS
ADEPT 1064/532 LASER
ADEPT MEDICAL CONCEPTS
ADEPT 1064/755 LASER
ADEPT MEDICAL CONCEPTS
ADEPT 1064/532/755 LASER
ADEPT MEDICAL CONCEPTS
GUDID#
NeoZoline - Vent Tube T-Tube 6mm
2016-02-25
NeoZoline - Vent Tube T-Tube 6mm - Double
2016-02-25
NeoZoline - Vent Tube T-Tube 9mm
2016-02-25
NeoZoline - Vent Tube T-Tube 9mm - Double
2016-02-25
NeoZoline - Vent Tube T-Tube 12mm
2016-02-25
NeoZoline - Vent Tube T-Tube 12mm - Double
2016-02-25
NeoZoline - Vent Tube Donaldson
2016-02-25
NeoZoline - Vent Tube Donaldson - Double
2016-02-25
Adept Medical Retrograde IR Platform - Narrow + Extension - Support Furniture
2026-02-09
Adept Medical IR Platform Extension - Narrow - Support Furniture, accessory to Retrograde IR Platform - Narrow
2026-02-09
Arm Straps - AM0620
2018-05-24
Adept Medical Femoral Table - Surgical Support Furniture
2017-05-29
IR Shield - Scatter Radiation Protection Shield
2017-11-24
Adept Medical Drape Support - Table Accessory to support drape over patient
2018-07-25
Adept Medical ArmSure - • ArmSure: To support the patient’s arm.• Arm Strap: To immobilise the patient’s arm, protecting the sterile field.• X-Ray Shield: To provide scatter radiation protection for clinician.
2024-03-20
Adept Medical STARTable - STARTable:• To provide an adjustable work surface.• To provide scatter radiation protection for clinician.
2024-02-15
Adept Medical Arm Support Pad - Arm Support Pad for STARBoard Arm Rest and Clinician Arm Support
2022-10-13
Adept Medical Drape Support - To support drape over patient face
2022-10-13
Adept Medical STARTable - Radiation Barrier, Support Furiture
2017-05-29
Arm Sure Shield - X-Ray Shield to ArmSure
2018-05-24
STARSupport - Accessory to STARBoard for Interventional Cardiology Left Arm Support
2018-05-24
Adept Medical STARBoard + Left Arm Support - Support Furniture
2017-05-29
Adept Medical STARSystem - Support Furniture
2017-05-29
STARBoard with Extension - Arm Support for Interventional Radiology
2017-11-24
Arm Sure - Support Furniture for Arm Embolization
2018-05-24
Arm Sure - Support Furniture, Arm Embolization
2018-05-24
Adept Medical Overhead Arm Support - Interventional Radiologists have requirement to carry out CT scans of patients for diagnostic and interventional procedures on a patient. This could be on an Angiography Table (Cone Beam CT) or within a CT Scanner (Conventional CT). Minimising X-ray artefact for these procedures is appealing hence the requirement to elevate the patients arms cranially to clear their torso, the region of interest. Interventional Radiologists also have requirement to raise arms clear of the patients torso sides to allow access for biliary drainage procedures.This device aims to facilitate both imaging and patient access application.
2019-01-25
Adept Medical Retrograde IR Platform - Narrow - Support Furniture
2025-03-21
Adept Medical Overhead Arm Support MR Safe - Small - To support the patient’s arms overhead with controlled shoulder flexion for imaging.
2025-03-20
Adept Medical Head Immobiliser Forehead Strap - Head Immobiliser Forehead Strap
2025-02-12
Adept Medical Overhead Arm Support MR Safe - To Support the patient's arms overhead with controller shoulder flexion for imaging. Intended for bores 70cm and upwards
2024-08-12
Adept Medical Head Immobiliser - Head Immobiliser
2024-08-12
Cerumen Hook - NZ3441-100
2024-04-23
Jobson Horne Probe - Oval - NZ3432-100
2024-04-23
Jobson Horne Probe - Oval, Sterile - NZ3432-20S
2024-04-23
Rosen Inserter - NZ3461-100
2024-04-23
Micro Ear Forceps, Stainless Steel, 4 mm Jaw, Ultra Fine, Non-Sterile - NZ3457-10NS
2024-04-23
Micro Ear Forceps, Stainless Steel, 4 mm Jaw, Non-Sterile - NZ3452-10NS
2024-04-23
Micro Ear Forceps, Stainless Steel, 7 mm Jaw, Non-Sterile - NZ3453B-10NS
2024-04-23
Tilley Nasal Forcep, 140 mm Non-Sterile - NZ6610-10NS
2024-04-23