Apatech Ltd
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Apatech Ltd is a medical device manufacturer, with 44 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and Unclassified) and 1 FDA recall as of 14 Nov 2026.
- Devices
- 44
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 36
- FDA 510(k) 8
- EUDAMED 3
- Device classes
- FDA Class II 41
- FDA Unclassified 3
- FDA recalls
- Sites and related companies
- Apatech Ltd. United Kingdom
- Identifiers
- DUNS 221517829
At a glance
Market reach
- United States
- FDA recalls
What Apatech Ltd makes
Apatech Ltd manufactures synthetic bone matrix implants and bone wax designed for surgical applications. Their portfolio includes granular, flowable, and pre-shaped bone graft substitutes, as well as antimicrobial bone wax variants for use in orthopedic and spinal procedures. These products are intended to support bone healing and filling defects without antimicrobial properties in most formulations.
The company’s devices are classified under FDA categories II and U, with regulatory submissions including 510(k) clearances and UDI listings. Their products are authorised for use in the United States, where the manufacturer is based.
Catalogue
Search and filter all 44 devicesCompany details
- DUNS number
- 221517829
- Phone
- +1(800)933-0303
FDA recalls
2015
- 18 Aug 2015 Z-1922-2016 Class II Terminated Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
Full distribution text
- 18 Aug 2015 Z-1922-2016 Class II Terminated Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
Sites
- Apatech Ltd. GBFEI 3004450973 0 devices
Frequently asked questions
How many devices does Apatech Ltd have in the registry?
The registry currently lists 44 devices for Apatech Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apatech Ltd's devices?
Among its 44 most recently registered devices, Apatech Ltd has devices listed in EUDAMED (3 devices), FDA 510(k) (8 devices) and FDA GUDID (36 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Apatech Ltd's devices fall under?
Among its 44 most recently registered devices, the classes recorded for Apatech Ltd's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Apatech Ltd?
FDA recall records list 1 recall initiated by Apatech Ltd, the most recent initiated on 18 Aug 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Apatech Ltd in the registry?
The most recently registered devices listed for Apatech Ltd include Actifuse ABX 506005078060, Actifuse Granules 506005078056, Actifuse MIS 506005078072 and Actifuse ABX 506005078052.