Peter Lazic GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000005519 FEI 3007264034
- Devices
- 2,331
- Registrations
- EUDAMEDFDA
- FDA recalls
- 55 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What Peter Lazic GmbH makes
Peter Lazic GmbH manufactures reusable surgical instruments for neurosurgery and open surgery, including aneurysm clips, aneurysm clip appliers, neurosurgical scissors, spinal rongeurs, dissectors, bipolar electrosurgical handpieces, soft-tissue manipulation forceps, and non-illuminating suction cannulae.
The company’s products are classified as Class I and Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 2,331 devicesShowing 1-50 of 2,331
Company details
- EUDAMED SRN
- DE-MF-000005519
- FDA FEI number
- 3007264034
- DUNS number
- 327681359
- EU VAT number
- DE213344752
- EUDAMED status
- Active
- EUDAMED registered name
- Peter Lazic GmbH
- Registered address
- 2, Immelmannweg, 78532, Tuttlingen, Germany
- Website
- www.lazic.de
- eudamed@lazic.de
- Phone
- +49 7461 96643 0
- PRRC contact
- Sven Lazic
FDA recalls
FDA recall records list 5 recalls initiated by Peter Lazic GmbH, the earliest on 2023-07-14 and the most recent on 2023-10-06. By recorded status: 5 ongoing. 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 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 5
- 2024 0
- 2025 0
- 2026 0
2023
- 6 Oct 2023 Z-1277-2024 Class II Ongoing Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
- 6 Oct 2023 Z-1278-2024 Class II Ongoing Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
- 6 Oct 2023 Z-1279-2024 Class II Ongoing Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
- 14 Jul 2023 Z-1287-2024 Class II Ongoing Wrong product coloring. The paddle clips should be blank, but they are colored blue.
- 14 Jul 2023 Z-1288-2024 Class II Ongoing Wrong product coloring. The paddle clips should be blank, but they are colored blue.
Frequently asked questions
How many devices does Peter Lazic GmbH have in the registry?
The registry currently lists 2331 devices for Peter Lazic GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Peter Lazic GmbH's devices?
Among its 50 most recently registered devices, Peter Lazic GmbH has devices listed in EUDAMED (20 devices) and FDA GUDID (30 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Peter Lazic GmbH's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Peter Lazic GmbH's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Peter Lazic GmbH?
FDA recall records list 5 recalls initiated by Peter Lazic GmbH, the most recent initiated on 6 Oct 2023. 5 of them are recorded as ongoing. 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 Peter Lazic GmbH in the registry?
The most recently registered devices listed for Peter Lazic GmbH include LAZIC 74.315.00, LAZIC 65.182, LAZIC 65.212 and LAZIC 65.226.