Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices
145
Total
145
Cleared
0
Denied
145 devices
Cleared
Jun 09, 1992
DURAFILL BOND
Dental
62d
Cleared
May 15, 1992
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
Hematology
74d
Cleared
Mar 24, 1992
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
Chemistry
60d
Cleared
Mar 19, 1992
PALAVIT G
Dental
162d
Cleared
Mar 18, 1992
ENCORE
Chemistry
126d
Cleared
Mar 11, 1992
DENTACOLOR(R) CRE-ACTIVE
Dental
156d
Cleared
Mar 11, 1992
MILES LIPASE SERA-PAK METHOD
Chemistry
47d
Cleared
Mar 04, 1992
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
Chemistry
40d
Cleared
Feb 03, 1992
TWINLOOK
Dental
69d
Cleared
Jan 31, 1992
ADS-GEL AND INSULATING-GEL
Dental
66d
Cleared
Jan 21, 1992
SILICOATER SYSTEM
Dental
56d
Cleared
Jan 17, 1992
ESTISEAL LC
Dental
70d
Cleared
Dec 18, 1991
TECHNICON CHEM 1 PLASMA GLUCOSE
Chemistry
56d
Cleared
Oct 09, 1991
ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL
Dental
51d
Cleared
Oct 09, 1991
MODERN MATERIALS ORTHODONTIC RESIN
Dental
51d
Cleared
Oct 04, 1991
MEMOSIL C.D.
Dental
56d
Cleared
Sep 05, 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
Hematology
147d
Cleared
Jun 06, 1991
CUTTERSIL MUCOSA
Dental
142d
Cleared
Jun 06, 1991
CUTTERSIL XL
Dental
142d
Cleared
Jun 06, 1991
PERFOURM PUTTY SOFT
Dental
141d
Cleared
Jun 06, 1991
CUTTERSIL FUNCTION ACTIVATOR
Dental
128d
Cleared
Jun 06, 1991
MELIODENT, DENTURE RESIN
Dental
122d
Cleared
Feb 11, 1991
HEMASTIX REAGENT STRIPS
Chemistry
73d
Cleared
Dec 26, 1990
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
Chemistry
112d
Cleared
Sep 11, 1990
OPTIMATE HEMOGLOBIN A1C
Hematology
281d
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