Data / Medical devices / New Zealand
Medical device makers in New Zealand: 35 FDA-registered establishments
35 establishments in New Zealand are registered with the FDA to make medical devices for the US market, listing 145 device types. 13 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- New ZealandCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Dressing, Wound, Drug | FRO | 3 |
| Components, Wheelchair | KNN | 3 |
| Tape And Bandage, Adhesive | KGX | 2 |
| Stand, Infusion | FOX | 2 |
| Tray, Surgical, Instrument | FSM | 2 |
| Table And Attachments, Operating-Room | BWN | 2 |
| Support, Head And Trunk, Wheelchair | IMS | 2 |
| Cushion, Wheelchair | IMP | 2 |
| Cup, Menstrual | HHE | 2 |
| Accessories, Wheelchair | KNO | 2 |
| Board, Lap, Wheelchair | IMX | 2 |
| Insufflator, Laparoscopic | HIF | 1 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 1 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 1 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 |
| Orthopedic Manual Surgical Instrument | LXH | 1 |
| Medical Device Data System | OUG | 1 |
| Reamer | HTO | 1 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | 1 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 1 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 1 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 1 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | 1 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | 1 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 1 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | 1 |
| Shoulder Prosthesis, Reverse Configuration | PHX | 1 |
| Orthopedic Stereotaxic Instrument | OLO | 1 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | 1 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | 1 |
| Mesh, Surgical | FTM | 1 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | 1 |
| Rasp | HTR | 1 |
| Calibrator, Secondary | JIT | 1 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 |
| Wound Dressing With Animal-Derived Material(S) | KGN | 1 |
| Dressing, Wound, Hydrophilic | NAC | 1 |
| Kit, Surgical Instrument, Disposable | KDD | 1 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | 1 |
| Syringe, Irrigating (Non Dental) | KYZ | 1 |
| Splint, Intranasal Septal | LYA | 1 |
| Support, Patient Position | CCX | 1 |
| Retractor | GAD | 1 |
| Template | HWT | 1 |
| Barrier, Animal Source, Intraoral | NPL | 1 |
| Bone Grafting Material, Animal Source | NPM | 1 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 |
| Dispenser, Liquid Medication | KYX | 1 |
| Bedding, Disposable, Medical | KME | 1 |
| Instruments, Dental Hand | DZN | 1 |
| Holder, Film, X-Ray | EGZ | 1 |
| Toothbrush, Manual | EFW | 1 |
| Bandage, Elastic | FQM | 1 |
| Massager, Therapeutic, Electric | ISA | 1 |
| Clamp | HXD | 1 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | 1 |
| Screwdriver | HXX | 1 |
| Impactor | HWA | 1 |
| Instrument, Compression | HWN | 1 |
| System, Image Processing, Radiological | LLZ | 1 |
| Gauge, Depth | HTJ | 1 |
| Caliper | KTZ | 1 |
| Guide, Surgical, Instrument | FZX | 1 |
| Extractor | HWB | 1 |
| Instrument, Cutting, Orthopedic | HTZ | 1 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 1 |
| Tubing, Pressure And Accessories | BYX | 1 |
| Nebulizer (Direct Patient Interface) | CAF | 1 |
| Ventilator, Non-Continuous (Respirator) | BZD | 1 |
| Filter, Bacterial, Breathing-Circuit | CAH | 1 |
| Ventilator, Continuous, Facility Use | CBK | 1 |
| Mask, Oxygen | BYG | 1 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 1 |
| Connector, Airway (Extension) | BZA | 1 |
| Support, Breathing Tube | JAY | 1 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 1 |
| Cannula, Nasal, Oxygen | CAT | 1 |
| Drain, Tee (Water Trap) | BYH | 1 |
| Valve, Non-Rebreathing | CBP | 1 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 |
| Tube, Ear Suction | JZF | 1 |
| Curette, Ear | JYG | 1 |
| Speculum, Ent | EPY | 1 |
| Forceps, Ent | KAE | 1 |
| Bed, Ac-Powered Adjustable Hospital | FNL | 1 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 |
| Collector, Ostomy | EXB | 1 |
| Orthosis, Lumbar | IQE | 1 |
| Massager, Powered Inflatable Tube | IRP | 1 |
| Hook, Bone | KIK | 1 |
| Device, Anti-Snoring | LRK | 1 |
| Chair And Table, Medical | KMN | 1 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 |
| Excavator, Ear | JYH | 1 |
| Barrier, Control Panel, X-Ray, Movable | IWX | 1 |
| Restoration, Resin | NSM | 1 |
| Orthosis, Limb Brace | IQI | 1 |
Makers in New Zealand
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | 36 | 96 | 0 | 8 | api.fda.gov |
| Aroa Biosurgery Ltd | Airport Oaks Auckland, New Zealand | 6 | 13 | 0 | 2 | api.fda.gov |
| Enztec Limited | CHRISTCHURCH Canterbury, New Zealand | 36 | 5 | 0 | 1 | api.fda.gov |
| Molteno Ophthalmic Ltd. | DUNEDIN Otago, New Zealand | 1 | 4 | 0 | 0 | api.fda.gov |
| Canterbury Scientific Ltd. | Christchurch Canterbury, New Zealand | 3 | 3 | 0 | 0 | api.fda.gov |
| ManukaMed Limited Partnership | Masterton Wellington, New Zealand | 2 | 3 | 0 | 0 | api.fda.gov |
| Alimetry Ltd | Auckland, New Zealand | 1 | 2 | 0 | 0 | api.fda.gov |
| Lunit International Limited | Wellington Central, New Zealand | 2 | 2 | 0 | 0 | api.fda.gov |
| Think Green Limited | Kumeu Auckland, New Zealand | 12 | 2 | 0 | 0 | api.fda.gov |
| Adept Medical Ltd | Auckland, New Zealand | 14 | 1 | 0 | 1 | api.fda.gov |
| Chitogel Limited | Upper Hutt Wellington, New Zealand | 1 | 1 | 0 | 0 | api.fda.gov |
| Innovative Health Technologies (NZ) Limited | Dunedin Otago, New Zealand | 1 | 1 | 0 | 0 | api.fda.gov |
| Medella Health Ltd | Tauranga Bay of Plenty, New Zealand | 1 | 1 | 0 | 0 | api.fda.gov |
| Accord Precision Limited | Manukau Auckland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Anzacare Ltd. | Waikanae Wellington, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| D3 New Zealand Limited | Rosedale Auckland, New Zealand | 2 | 0 | 0 | 0 | api.fda.gov |
| Dynamic Controls | CHRISTCHURCH Canterbury, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| F.r.galantai Manufacturing Company Limited | Auckland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Foot Science International, Ltd. | CHRISTCHURCH Canterbury, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Howard Wright Limited | New Plymouth Taranaki, New Zealand | 3 | 0 | 0 | 0 | api.fda.gov |
| Keraplast Limited | Christchurch Canterbury, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Metalform Ltd | Dannevirke Hawke's Bay, New Zealand | 18 | 0 | 0 | 0 | api.fda.gov |
| Moregate Exports Ltd | HAMILTON Northland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| My Better Breathing Ltd | Auckland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Opum Technologies Services | Newmarket Auckland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| OptiRTP Limited | Auckland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Plastech Industries. | Christchurch Canterbury, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Popstix Ltd | Auckland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Rhondium Limited | Katikati Bay of Plenty, New Zealand | 2 | 0 | 0 | 1 | api.fda.gov |
| Showerbuddy New Zealand Ltd | Wellington, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Spex Ltd | Rolleston Canterbury, New Zealand | 5 | 0 | 0 | 0 | api.fda.gov |
| TASKA Prosthetics | Christchurch Canterbury, New Zealand | 2 | 0 | 0 | 0 | api.fda.gov |
| The Hello Cup | Auckland, New Zealand | 2 | 0 | 0 | 0 | api.fda.gov |
| The Insides Company Limited | Auckland, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
| Top Operator Products | CAMBRIDGE Waikato, New Zealand | 1 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.