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
101-125 of 145
Cleared Jun 09, 1992
DURAFILL BOND
K921701 · KLE
Dental · 62d
Cleared May 15, 1992
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
K920949 · GKZ
Hematology · 74d
Cleared Mar 24, 1992
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
K920335 · CKA
Chemistry · 60d
Cleared Mar 19, 1992
PALAVIT G
K914513 · EGD
Dental · 162d
Cleared Mar 18, 1992
ENCORE
K915113 · JJQ
Chemistry · 126d
Cleared Mar 11, 1992
DENTACOLOR(R) CRE-ACTIVE
K914456 · EBF
Dental · 156d
Cleared Mar 11, 1992
MILES LIPASE SERA-PAK METHOD
K920337 · CHI
Chemistry · 47d
Cleared Mar 04, 1992
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
K920336 · CIT
Chemistry · 40d
Cleared Feb 03, 1992
TWINLOOK
K915336 · EBF
Dental · 69d
Cleared Jan 31, 1992
ADS-GEL AND INSULATING-GEL
K915355 · EBF
Dental · 66d
Cleared Jan 21, 1992
SILICOATER SYSTEM
K915335 · EBF
Dental · 56d
Cleared Jan 17, 1992
ESTISEAL LC
K915095 · EBC
Dental · 70d
Cleared Dec 18, 1991
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · CFR
Chemistry · 56d
Cleared Oct 09, 1991
ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL
K913698 · EBI
Dental · 51d
Cleared Oct 09, 1991
MODERN MATERIALS ORTHODONTIC RESIN
K913699 · EBI
Dental · 51d
Cleared Oct 04, 1991
MEMOSIL C.D.
K913537 · ELW
Dental · 56d
Cleared Sep 05, 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
K911625 · LCP
Hematology · 147d
Cleared Jun 06, 1991
CUTTERSIL MUCOSA
K910165 · ELW
Dental · 142d
Cleared Jun 06, 1991
CUTTERSIL XL
K910166 · ELW
Dental · 142d
Cleared Jun 06, 1991
PERFOURM PUTTY SOFT
K910189 · ELW
Dental · 141d
Cleared Jun 06, 1991
CUTTERSIL FUNCTION ACTIVATOR
K910360 · ELW
Dental · 128d
Cleared Jun 06, 1991
MELIODENT, DENTURE RESIN
K910465 · EBI
Dental · 122d
Cleared Feb 11, 1991
HEMASTIX REAGENT STRIPS
K905396 · JIO
Chemistry · 73d
Cleared Dec 26, 1990
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081 · CGA
Chemistry · 112d
Cleared Sep 11, 1990
OPTIMATE HEMOGLOBIN A1C
K896830 · LCP
Hematology · 281d

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