Data / Medical devices / Germany / Vitalitec International Medizintechnik GmbH
Vitalitec International Medizintechnik GmbH: FDA-registered device maker in BALGHEIM Baden-Wurttemberg, Germany, 8 510(k) clearances
Vitalitec International Medizintechnik GmbH is registered with the FDA (registration 8044057) in BALGHEIM Baden-Wurttemberg, Germany. It lists 18 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 18, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8044057
- FEI number
- 3003445992
- Address
- Steigaecker 20, BALGHEIM Baden-Wurttemberg, Germany, 78582
- Owner or operator
- VITALITEC INTERNATIONAL MEDIZINTECHNIK GMBH (9005335)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- June 4, 1992
- Registered through
- 2026
- Brand names listed
- Aesculap, Arthroscopic sheaths/trocars, Dissecting scissors, Elevator, Enlarging Bur, Forceps, Forceps, Biopsy, Gynecological, Grasping and Dissecting Forceps, Scissors, endoscopy and more
Devices it lists
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 18, 2016 | K152734 | Kerrison Rongeurs | HAE | Substantially Equivalent | Vitalitec Medizintechnik GmbH | accessdata.fda.gov |
| July 19, 2006 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| August 6, 1998 | K981919 | BISSINGER CABLES, CAT. NO. 801000XX | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| September 29, 1995 | K944444 | CIT BIOPSY PUNCHES | HFB | Substantially Equivalent | Chirurgische Instrumente | accessdata.fda.gov |
| July 25, 1995 | K944270 | CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS | HET | Substantially Equivalent | Chirurgische Instrumente | accessdata.fda.gov |
| April 25, 1995 | K942730 | AESCULAP LAPAROSCOPES | HET | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 26, 1995 | K944268 | CIT TWO WAY SUCTIN AND IRRIGATION TUBES | HET | Substantially Equivalent | Chirurgische Instrumente | accessdata.fda.gov |
| January 24, 1995 | K944269 | CIT GRASPING AND DISSECTING FORCEPS | HET | Substantially Equivalent | Chirurgische Instrumente | accessdata.fda.gov |
Compare with other makers
- All makers of Rongeur
- All makers of Bur, Surgical, General & Plastic Surgery
- All makers of Forceps, Rongeur, Surgical
- All makers of Accessories, Arthroscopic
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Saw, Manual And Accessories
Updated June 18, 2016. 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.