Data / Medical devices / Germany / Heinz Kurz GMBH Medizintechnik
Heinz Kurz GMBH Medizintechnik: FDA-registered device maker in DUSSLINGEN Baden-Wurttemberg, Germany, 14 510(k) clearances
Heinz Kurz GMBH Medizintechnik is registered with the FDA (registration 8010617) in DUSSLINGEN Baden-Wurttemberg, Germany. It lists 11 device types. The FDA files 14 510(k) clearances under its listings, the newest dated December 2, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8010617
- FEI number
- 6062
- Address
- Tuebinger Strasse 3, DUSSLINGEN Baden-Wurttemberg, Germany, D-72144
- Owner or operator
- HEINZ KURZ GMBH (8010617)
- Roles
- Manufacturer
- First device listed
- September 8, 1997
- Registered through
- 2026
- Brand names listed
- AC Sizer System Partial, AC Sizer System Total, Angular CliP Prosthesis, Angular Piston Stapes Prosthesis, Angular Prosthesis Plester, Beveled Type Ventilation Tubes, Blades sterile single packed for KURZ Precise, Bucket Type Stapes Prosthesis and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Measuring | JYJ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile | NNS | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Partial Ossicular Replacement | ETB | 2 | Manufacturer | accessdata.fda.gov |
| Replacement, Ossicular Prosthesis, Total | ETA | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Ent | MMO | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tympanostomy | ETD | 2 | Manufacturer | accessdata.fda.gov |
| Weights, Eyelid, External | MML | 2 | 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 |
|---|---|---|---|---|---|---|
| December 2, 2013 | K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS | ETB | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| February 8, 2013 | K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | ETB | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| December 12, 2007 | K071150 | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE | ETD | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| October 1, 2004 | K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | ETA | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| May 21, 2002 | K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | ETB | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| November 9, 2001 | K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | ETB | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| May 2, 2001 | K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | MML | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| March 8, 2001 | K010442 | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 | ETB | Substantially Equivalent | Heinz Kurz | accessdata.fda.gov |
| August 9, 2000 | K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 | ETB | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| April 21, 2000 | K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | MML | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| March 31, 1999 | K990923 | TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 | ETB | Substantially Equivalent | Heinz Kurz | accessdata.fda.gov |
| November 4, 1997 | K973226 | TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) | ETD | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| August 4, 1997 | K972585 | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN | ETA | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik | accessdata.fda.gov |
| August 4, 1997 | K972492 | BELL PROSTHESIS (PARTIAL) | ETB | Substantially Equivalent | Heinz Kurz | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2011 | 58809 | Not yet classified | Terminated | Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06. Product is designed for ossicular replacement to functional | Outer package labels product.75 mm longer than actual size. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Measuring
- All makers of Cutter, Surgical
- All makers of Prosthesis, Partial Ossicular Replacement
- All makers of Blade, Scalpel
- All makers of Weights, Eyelid, External
- All makers of Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
Updated December 2, 2013. 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.