FEI 3002808043
Rudolf Storz Gmbh
FRIEDRICH-WOEHLER-STR. 13, EMMINGEN Baden-Wurttemberg, DE
MDR events7All time
Recalls0All time
Registered products100
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
100 product codes
Recent MDR events
7 on file
- HOHMANN RETRACTOR, BLADE WIDTH 16MM, WITH FINGERMay 5, 2009Other9611274-2009-00001
- *Jan 10, 2008Other9611274-2007-00003
- FAVALORO-MORSE STERNAL RETRACTORDec 26, 2007Malfunction2430952-2007-00055
- FAVALORO-MORSE STERNAL RETRACTOROct 29, 2007Malfunction2430952-2007-00045
- SCOVILLE HEMILAMINECTOMY RETRACTOR FRAME, SPREJul 26, 2007Malfunction2430952-2007-00019
- O'SULLIVAN-O'CONNOR ABDOMINAL RETRACTOR WITH 3Feb 13, 2006Malfunction2430952-2006-00005
- BALFOUR WIRE LATERAL BLADE FOR 205-295 AND 205-296Sep 15, 2005Malfunction2430952-2005-00030
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002808043.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 25, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Sep 25, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(g)(1)Sep 25, 2025
Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.80(d)Sep 25, 2025
Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Sep 25, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Sep 25, 2025
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.