Medical Device Manufacturer · US , Elkhart , IN

Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices

145 submissions · 145 cleared · Since 1988

145

Total

145

Cleared

0

Denied

145 devices

26-50 of 145

Cleared Oct 14, 1999

GLUMA COMFORT BOND

Cleared Oct 01, 1999

GLUMA COMFORT BOND + DESENSITIZER

Cleared Jun 15, 1999

XANTOPREN COMFORT

Cleared May 07, 1999

Cleared Feb 25, 1999

Cleared Jul 15, 1998

NTI CLENCHING SUPPRESSION SYSTEM

Cleared Feb 04, 1998

Cleared Nov 24, 1997

Cleared Oct 02, 1997

Cleared Sep 29, 1997

Cleared May 22, 1997

Cleared May 06, 1997

Cleared Apr 02, 1997

CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG

Cleared Mar 19, 1997

CUTTERSIL COMFORT

Cleared Mar 19, 1997

CUTTERSIL COMFORT HARDENER

Cleared Nov 05, 1996

GLUMA CONDITIONER

Cleared Oct 07, 1996

GLUMA DESENSITIZER/GLUMA 3 PRIMER

Cleared Jun 26, 1996

Cleared Nov 27, 1995

CHARISMA SINGLE DOSE

Cleared Oct 02, 1995

Cleared Sep 27, 1995

ARTGLASS & KEVLOC

Cleared Jun 01, 1995

GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION

Chemistry · 86d

Cleared May 05, 1995

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C

Chemistry · 39d

Cleared Feb 22, 1995

CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER

Chemistry · 64d

Cleared Oct 31, 1994

NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000,...

Chemistry · 89d

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