Newdeal SAS
Country not established
Newdeal SAS is a medical device manufacturer, with 1,141 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 5 FDA recalls as of 12 Nov 2026.
- Devices
- 1,141
- FDA recalls
- 5
Registry facts
- Registries
- FDA GUDID 1,131
- FDA 510(k) 10
- Device classes
- FDA Class II 752
- FDA Class I 389
- FDA recalls
At a glance
Market reach
- United States
- FDA recalls
What Newdeal SAS makes
Newdeal Sas manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile), fixation plates, and non-adjustable bone staples. Their portfolio also includes reusable surgical tools such as drill guides, implant templates, and screwdrivers, as well as sterilization/disinfection containers for medical devices.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Newdeal Sas operates from the United States.
Catalogue
Search and filter all 1,141 devicesShowing 1-50 of 1,141
FDA recalls
FDA recall records list 5 recalls initiated by Newdeal Sas, initiated on 2018-05-22. By recorded status: 5 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 5
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 22 May 2018 Z-2443-2018 Class II Terminated Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- 22 May 2018 Z-2444-2018 Class II Terminated Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- 22 May 2018 Z-2445-2018 Class II Terminated Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- 22 May 2018 Z-2446-2018 Class II Terminated Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- 22 May 2018 Z-2447-2018 Class II Terminated Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Frequently asked questions
How many devices does Newdeal Sas have in the registry?
The registry currently lists 1141 devices for Newdeal Sas. Devices recorded under merged duplicate company entries are counted once.
Which registries list Newdeal Sas's devices?
Among its 50 most recently registered devices, Newdeal Sas has devices listed in FDA GUDID (50 devices).
What risk classes do Newdeal Sas's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Newdeal Sas's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Newdeal Sas?
FDA recall records list 5 recalls initiated by Newdeal Sas, the most recent initiated on 22 May 2018. 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 Newdeal Sas in the registry?
The most recently registered devices listed for Newdeal Sas include I.CO.S® 119536ND, SURFIX Alpha 295210SND, LARGE QWIX® 119177ND and PANTA 501075ND.