Heinz Kurz GmbH Medizintechnik
DUSSLINGEN Baden-Wurttemberg, DE
HEINZ KURZ GMBH MEDIZINTECHNIK appears in FDA device records in DUSSLINGEN Baden-Wurttemberg, DE. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Heinz Kurz GmbH Medizintechnik between 1997 and 2013. The busiest year on record is 2000, with 3. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 1 |
| 2004 | 2 |
| 2007 | 1 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS | ETB | Substantially Equivalent | |
| K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | ETB | Substantially Equivalent | |
| K071150 | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE | ETD | Substantially Equivalent | |
| K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | ETA | Substantially Equivalent | |
| K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | KHJ | Substantially Equivalent | |
| K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | ETB | Substantially Equivalent | |
| K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | ETB | Substantially Equivalent | |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | MML | Substantially Equivalent | |
| K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 | ETB | Substantially Equivalent | |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | MML | Substantially Equivalent | |
| K000127 | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | MML | Substantially Equivalent | |
| K992839 | SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE | ETB | Substantially Equivalent | |
| K973226 | TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) | ETD | Substantially Equivalent | |
| K972585 | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN | ETA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010617 | 6062 | HEINZ KURZ GMBH MEDIZINTECHNIK | TUEBINGER STRASSE 3, DUSSLINGEN Baden-Wurttemberg D-72144 DE | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GESBlade, Scalpel
- FZTCutter, Surgical
- KAEForceps, Ent
- JYJGauge, Measuring
- LRCInstrument, Ent Manual Surgical
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- ETBProsthesis, Partial Ossicular Replacement
- ETAReplacement, Ossicular Prosthesis, Total
- MMOTray, Surgical, Ent
- ETDTube, Tympanostomy
- MMLWeights, Eyelid, External
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2711-2011 | 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 functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism. | Outer package labels product .75 mm longer than actual size. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain