Heinz Kurz GmbH Medizintechnik
Country not established FDA
- Devices
- 14
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Heinz Kurz GmbH Medizintechnik makes
Heinz Kurz GmbH Medizintechnik manufactures otologic and ophthalmic implants and prostheses, including platinum/iridium and pure gold upper eyelid implants, titanium clip partial prostheses, and stapes prostheses such as the Nitiflex, NitiBond, and NitiPlast. Their portfolio also includes tympanic ventilation tubes (e.g., Tubingen, Diabolo, Minimal T), trocar ventilation tubes with retention wire, and silicone strips for medical applications. Clip piston devices, such as the Awengen and Kurz MVP, are designed for middle ear reconstruction, while aerial prostheses (e.g., Dusseldorf, Dresden) serve as auditory implants.
The company’s devices are classified as Class II under FDA regulations and are recorded in the FDA’s 510(k) clearance registry. These products are intended for use in the United States, where regulatory compliance is required for market authorisation. No additional registries or jurisdictions are specified for these devices.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 1 recall initiated by Heinz Kurz GmbH Medizintechnik, initiated on 2011-04-27. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 27 Apr 2011 Z-2711-2011 Unclassified (pre-2012) Terminated Outer package labels product .75 mm longer than actual size.
FDA establishments
- Heinz Kurz GmbH Medizintechnik DUSSLINGEN Baden-Wurttemberg · DE Other ID 6062
Frequently asked questions
How many devices does Heinz Kurz GmbH Medizintechnik have in the registry?
The registry currently lists 14 devices for Heinz Kurz GmbH Medizintechnik. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heinz Kurz GmbH Medizintechnik's devices?
Among its 14 most recently registered devices, Heinz Kurz GmbH Medizintechnik has devices listed in FDA 510(k) (14 devices).
What risk classes do Heinz Kurz GmbH Medizintechnik's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Heinz Kurz GmbH Medizintechnik's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Heinz Kurz GmbH Medizintechnik?
FDA recall records list 1 recall initiated by Heinz Kurz GmbH Medizintechnik, the most recent initiated on 27 Apr 2011. 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 Heinz Kurz GmbH Medizintechnik in the registry?
The most recently registered devices listed for Heinz Kurz GmbH Medizintechnik include KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM, MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010, CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861, NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS and TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE.
Which FDA establishments are linked to Heinz Kurz GmbH Medizintechnik?
1 FDA establishment is linked to Heinz Kurz GmbH Medizintechnik in the registry; they are listed on the company page.