FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

146 results for "Heraeus Kulzer, Inc."
49–72 of 146
Search insights Median review: 75d Cleared: 100% Top manufacturer: Heraeus Kulzer, Inc. Lead specialty: Dental
Cleared May 05, 1995
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
K951361 · LCP
Heraeus Kulzer, Inc.
Chemistry · 39d
Cleared Feb 22, 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183 · KQO
Heraeus Kulzer, Inc.
Chemistry · 64d
Cleared Oct 31, 1994
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000,...
K943780 · JJW
Heraeus Kulzer, Inc.
Chemistry · 89d
Cleared Jul 19, 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · LCP
Heraeus Kulzer, Inc.
Hematology · 139d
Cleared Jun 13, 1994
GLUCOMETER ELITE LOW CONTROL
K940577 · JJX
Heraeus Kulzer, Inc.
Chemistry · 125d
Cleared May 10, 1994
GLUCOFILM TEST STRIPS
K936212 · CGA
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared Apr 07, 1994
DENTACOLOR VITA (VS) SHADE SYSTEM
K940800 · EBF
Heraeus Kulzer, Inc.
Dental · 44d
Cleared Mar 07, 1994
ATTACHMENT BOND
K935735 · KLE
Heraeus Kulzer, Inc.
Dental · 96d
Cleared Jan 26, 1994
CHARISMA SUPERLIGHT
K935736 · EBF
Heraeus Kulzer, Inc.
Dental · 56d
Cleared Jan 05, 1994
IMPAX 5000
K934386 · LMD
Heraeus Kulzer, Inc.
Radiology · 119d
Cleared Dec 14, 1993
IMPAX 3000
K934832 · JAK
Heraeus Kulzer, Inc.
Radiology · 67d
Cleared Dec 10, 1993
DENTALON PLUS MODIFICATION
K934283 · EBG
Heraeus Kulzer, Inc.
Dental · 101d
Cleared Dec 07, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · CFR
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Dec 07, 1993
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
K934898 · CGA
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Nov 10, 1993
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · CEC
Heraeus Kulzer, Inc.
Chemistry · 292d
Cleared Nov 10, 1993
GLUCOSTIX REAGENT STRIPS
K926362 · CGA
Heraeus Kulzer, Inc.
Chemistry · 324d
Cleared Nov 03, 1993
IMPAX 1000
K933409 · LMD
Heraeus Kulzer, Inc.
Radiology · 114d
Cleared Sep 08, 1993
GLUCOFILM TEST STRIPS
K926360 · CGA
Heraeus Kulzer, Inc.
Chemistry · 261d
Cleared Aug 06, 1993
PALAVIT 55 AND DENTACOLOR CONNECTOR
K932034 · EBG
Heraeus Kulzer, Inc.
Dental · 101d
Cleared Jul 20, 1993
MATRIX CCM 600
K926009 · IYO
Heraeus Kulzer, Inc.
Radiology · 230d
Cleared Jul 08, 1993
CHARISMA -- MODIFIED
K932013 · EBF
Heraeus Kulzer, Inc.
Dental · 76d
Cleared Jul 08, 1993
DENTHESIVE II
K931838 · KLE
Heraeus Kulzer, Inc.
Dental · 86d
Cleared Jun 25, 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · CGA
Heraeus Kulzer, Inc.
Chemistry · 102d
Cleared Jun 24, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
K926361 · CFR
Heraeus Kulzer, Inc.
Chemistry · 185d