Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices
145
Total
145
Cleared
0
Denied
145 devices
Cleared
Jul 19, 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
Hematology
139d
Cleared
Jun 13, 1994
GLUCOMETER ELITE LOW CONTROL
Chemistry
125d
Cleared
May 10, 1994
GLUCOFILM TEST STRIPS
Chemistry
133d
Cleared
Apr 07, 1994
DENTACOLOR VITA (VS) SHADE SYSTEM
Dental
44d
Cleared
Mar 07, 1994
ATTACHMENT BOND
Dental
96d
Cleared
Jan 26, 1994
CHARISMA SUPERLIGHT
Dental
56d
Cleared
Jan 05, 1994
IMPAX 5000
Radiology
119d
Cleared
Dec 14, 1993
IMPAX 3000
Radiology
67d
Cleared
Dec 10, 1993
DENTALON PLUS MODIFICATION
Dental
101d
Cleared
Dec 07, 1993
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
Chemistry
55d
Cleared
Dec 07, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
Chemistry
55d
Cleared
Nov 10, 1993
GLUCOSTIX REAGENT STRIPS
Chemistry
324d
Cleared
Nov 10, 1993
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
Chemistry
292d
Cleared
Nov 03, 1993
IMPAX 1000
Radiology
114d
Cleared
Sep 08, 1993
GLUCOFILM TEST STRIPS
Chemistry
261d
Cleared
Aug 06, 1993
PALAVIT 55 AND DENTACOLOR CONNECTOR
Dental
101d
Cleared
Jul 20, 1993
MATRIX CCM 600
Radiology
230d
Cleared
Jul 08, 1993
DENTHESIVE II
Dental
86d
Cleared
Jul 08, 1993
CHARISMA -- MODIFIED
Dental
76d
Cleared
Jun 25, 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
Chemistry
102d
Cleared
Jun 24, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
Chemistry
185d
Cleared
Jun 22, 1993
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
Hematology
132d
Cleared
Jun 18, 1993
PALATRAY LC MINT
Dental
140d
Cleared
May 20, 1993
PMI100 VIDEO IMAGER
Radiology
216d
Cleared
May 11, 1993
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
Hematology
119d
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