Data / Medical devices / Germany / SPIEGELBERG GmbH & Co. KG
SPIEGELBERG GmbH & Co. KG: FDA-registered device maker in Hamburg, Germany, 1 510(k) clearance
SPIEGELBERG GmbH & Co. KG is registered with the FDA (registration 3002108226) in Hamburg, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 2001. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002108226
- Address
- Tempowerkring 4, Hamburg, Germany, 21079
- Owner or operator
- Spiegelberg GmbH & Co. KG (10037562)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 26, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 28, 2001 | K003759 | AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR | GWM | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 29, 2009 | 75160 | Class II | Terminated | Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intrac | In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg. | accessdata.fda.gov |
Compare with other makers
Updated June 28, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.