CustoMED Ltd
Active in EUDAMEDIsraelfrom SRN EUDAMED SRN IL-MF-000050512
Part of Customed, Inc.
CustoMED Ltd is a medical device manufacturer based in Israel, with 2 devices listed in EUDAMED and FDA 510(k) (EU Class I; FDA Class II) and 699 FDA recalls as of 12 Nov 2026.
- Devices
- 2
- Registrations
- EUDAMED
- FDA recalls
- 699
Registry facts
- Registries
- EUDAMED 1
- FDA 510(k) 1
- Device classes
- EU Class I 1
- FDA Class II 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Part of Customed, Inc.
- MDSS GmbH authorised representative
- Identifiers
- EUDAMED SRN IL-MF-000050512
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- MDSS GmbHDE
What CustoMED Ltd makes
CustoMED Ltd manufactures the CustoMED Viewer, a device designed for visual inspection or diagnostic imaging in medical settings. This product is intended for use in procedures requiring real-time or recorded visual assessment of anatomical structures or medical conditions.
The CustoMED Viewer falls under EU Device Class I classification and is registered in the EU’s eudamed database. The company is based in Israel.
Catalogue
CustoMED Viewer Ref K260116
Regimes: 510(k) Registry: 510(k)CustoMED Viewer Ref 07290020565006
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- IL-MF-000050512
- EUDAMED status
- Active
- EUDAMED registered name
- CustoMED Ltd
- EUDAMED abbreviated name
- CustoMED
- Registered address
- 64, Derech Sheba, 5262000, Ramat Gan, Israel
- Website
- www.customed.ai/
- support@customed.ai
- PRRC contact
- Liat Diamant Porat
FDA recalls
FDA recall records list 699 recalls initiated by CustoMED Ltd, the earliest on 2011-12-08 and the most recent on 2016-01-07. By recorded status: 699 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 7 Jan 2016 Z-1397-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1398-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1399-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1400-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1401-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1402-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1403-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1404-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1405-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1406-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Show the 25 most recent of 699 recalls
2016
- 7 Jan 2016 Z-1407-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1408-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1409-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1410-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1411-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1412-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1413-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1414-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1415-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1416-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1417-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1418-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1419-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1420-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 7 Jan 2016 Z-1421-2016 Class II Terminated Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
From the company website
End-to-end platform turning medical scans into patient-specific surgical plans, tools & implants instantly. AI-powered surgical planning in minutes.
Frequently asked questions
How many devices does CustoMED Ltd have in the registry?
The registry currently lists 2 devices for CustoMED Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list CustoMED Ltd's devices?
Among its 2 most recently registered devices, CustoMED Ltd has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CustoMED Ltd's devices fall under?
Among its 2 most recently registered devices, the classes recorded for CustoMED Ltd's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for CustoMED Ltd?
FDA recall records list 699 recalls initiated by CustoMED Ltd, the most recent initiated on 7 Jan 2016. 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 CustoMED Ltd in the registry?
The most recently registered devices listed for CustoMED Ltd include CustoMED Viewer.