Heinz Kurz GmbH Medizintechnik

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISDecember 2, 2013
K112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISFebruary 8, 2013
K071150TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077December 12, 2007
K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMOctober 1, 2004
K033796KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BSJanuary 30, 2004
K021479CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861May 21, 2002
K013573CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257November 9, 2001
K011115KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-May 2, 2001
K002221KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170August 9, 2000
K001123KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111April 21, 2000
K000127KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10April 12, 2000
K992839SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSESeptember 16, 1999
K973226TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATNovember 4, 1997
K972585AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESISAugust 4, 1997