Heraeus Kulzer Inc

FDA Filings

This page includes the latest FDA filings for Heraeus Kulzer Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
HERAEUS KULZER, INC.
FLEXITIME FLOW2009-07-31
HERAEUS KULZER, INC.
HKBOND 20062006-12-01
HERAEUS KULZER, INC.
MONDIAL2006-05-22
HERAEUS KULZER, INC.
HERACERAM ZIRKONIA2005-10-25
HERAEUS KULZER, INC.
VERSYO.DIRECT2005-01-05
HERAEUS KULZER, INC.
FLEXITIME XTREME2004-12-17
HERAEUS KULZER, INC.
OSTIM2004-12-06
HERAEUS KULZER, INC.
NDX-40 ALLOY2004-03-03
HERAEUS KULZER, INC.
ARTIC2004-01-16
HERAEUS KULZER, INC.
VENUS FLOW2003-12-30
HERAEUS KULZER, INC.
VERSYO.BOND2003-12-22
HERAEUS KULZER, INC.
P2 POLYETHER2003-04-03
HERAEUS KULZER, INC.
VENUS UNIVERSAL LIGHT CURING COMPOSITE2002-02-28
HERAEUS KULZER, INC.
PREMIUM2001-07-05
HERAEUS KULZER, INC.
VERSYO.COM2001-05-31
HERAEUS KULZER, INC.
FLEXTIME MAGNUM 3602001-02-01
HERAEUS KULZER, INC.
FLEXTIME2000-04-05
HERAEUS KULZER, INC.
SOLITAIRE 21999-12-22
HERAEUS KULZER, INC.
PRE-VISION FILL1999-12-15
HERAEUS KULZER, INC.
GLUMA COMFORT BOND1999-10-14
HERAEUS KULZER, INC.
GLUMA COMFORT BOND + DESENSITIZER1999-10-01
HERAEUS KULZER, INC.
XANTOPREN COMFORT1999-06-15
HERAEUS KULZER, INC.
FLOW LINE1999-05-07
HERAEUS KULZER, INC.
GLUMA ONE BOND1999-02-25
HERAEUS KULZER, INC.
NTI CLENCHING SUPPRESSION SYSTEM1998-07-15
HERAEUS KULZER, INC.
GLUMA ONE BOND1998-02-04
HERAEUS KULZER, INC.
PROVIL NOVO1997-11-24
HERAEUS KULZER, INC.
2 BOND 21997-10-02
HERAEUS KULZER, INC.
SOLITAIRE1997-09-29
HERAEUS KULZER, INC.
MEMOREG1997-05-22
HERAEUS KULZER, INC.
SILOC SYSTEM1997-05-06
HERAEUS KULZER, INC.
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG1997-04-02
HERAEUS KULZER, INC.
CUTTERSIL COMFORT HARDENER1997-03-19
HERAEUS KULZER, INC.
CUTTERSIL COMFORT1997-03-19
HERAEUS KULZER, INC.
GLUMA CONDITIONER1996-11-05
HERAEUS KULZER, INC.
GLUMA DESENSITIZER/GLUMA 3 PRIMER1996-10-07
HERAEUS KULZER, INC.
QUICKSPLINT1996-06-26
HERAEUS KULZER, INC.
CHARISMA SINGLE DOSE1995-11-27
HERAEUS KULZER, INC.
PALASPLINT1995-10-02
HERAEUS KULZER, INC.
ARTGLASS & KEVLOC1995-09-27
HERAEUS KULZER, INC.
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION1995-06-01
HERAEUS KULZER, INC.
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C1995-05-05
HERAEUS KULZER, INC.
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER1995-02-22
HERAEUS KULZER, INC.
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)1994-10-31
HERAEUS KULZER, INC.
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS1994-07-19
HERAEUS KULZER, INC.
GLUCOMETER ELITE LOW CONTROL1994-06-13
HERAEUS KULZER, INC.
GLUCOFILM TEST STRIPS1994-05-10
HERAEUS KULZER, INC.
DENTACOLOR VITA (VS) SHADE SYSTEM1994-04-07
HERAEUS KULZER, INC.
CHARISMA SUPERLIGHT1994-01-26
HERAEUS KULZER, INC.
IMPAX 50001994-01-05
HERAEUS KULZER, INC.
IMPAX 30001993-12-14
HERAEUS KULZER, INC.
DENTALON PLUS MODIFICATION1993-12-10
HERAEUS KULZER, INC.
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION1993-12-07
HERAEUS KULZER, INC.
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION1993-12-07
HERAEUS KULZER, INC.
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)1993-11-10
HERAEUS KULZER, INC.
GLUCOSTIX REAGENT STRIPS1993-11-10
HERAEUS KULZER, INC.
IMPAX 10001993-11-03
HERAEUS KULZER, INC.
GLUCOFILM TEST STRIPS1993-09-08
HERAEUS KULZER, INC.
PALAVIT 55 AND DENTACOLOR CONNECTOR1993-08-06
HERAEUS KULZER, INC.
MATRIX CCM 6001993-07-20
HERAEUS KULZER, INC.
CHARISMA -- MODIFIED1993-07-08
HERAEUS KULZER, INC.
DENTHESIVE II1993-07-08
HERAEUS KULZER, INC.
GLUCOMETER M+ BLOOD GLUCOSE METER1993-06-25
HERAEUS KULZER, INC.
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER1993-06-24
HERAEUS KULZER, INC.
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)1993-06-22
HERAEUS KULZER, INC.
PALATRAY LC MINT1993-06-18
HERAEUS KULZER, INC.
PMI100 VIDEO IMAGER1993-05-20
HERAEUS KULZER, INC.
CHEK-STIX CONTROL STRIPS FOR URINALYSIS1993-05-11
HERAEUS KULZER, INC.
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)1993-05-11
HERAEUS KULZER, INC.
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO1993-04-20
HERAEUS KULZER, INC.
MATRIX CR 2050, PMI 30001993-04-08
HERAEUS KULZER, INC.
CLINITEK 200+ URINE CHEMISTRY ANALYZER1993-01-28
HERAEUS KULZER, INC.
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS1993-01-27
HERAEUS KULZER, INC.
ELITE TEST STRIPS GLUCOMETER1992-12-17
HERAEUS KULZER, INC.
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.11992-11-25
HERAEUS KULZER, INC.
ORTHO WAX1992-11-17
HERAEUS KULZER, INC.
PALABOND1992-11-04
HERAEUS KULZER, INC.
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD1992-10-14
HERAEUS KULZER, INC.
PALADISC LC1992-09-29
HERAEUS KULZER, INC.
MILES URINE AMYLASE METHOD1992-09-28
HERAEUS KULZER, INC.
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE1992-09-23
HERAEUS KULZER, INC.
ENCORE TEST STRIPS1992-09-23
HERAEUS KULZER, INC.
MILES AUTO METH DETERMIN OF URIC ACID IN URINE1992-09-22
HERAEUS KULZER, INC.
MILES SODIUM METHOD1992-09-22
HERAEUS KULZER, INC.
PALADUR1992-09-16
HERAEUS KULZER, INC.
MILES URINE GLUCOSE METHOD1992-09-15
HERAEUS KULZER, INC.
MILES URINE CALCIUM METHOD1992-09-15
HERAEUS KULZER, INC.
TECHNICON H*21992-09-11
HERAEUS KULZER, INC.
URINE CHLORIDE1992-09-09
HERAEUS KULZER, INC.
MILES URINE UREA NITROGEN METHOD1992-09-09
HERAEUS KULZER, INC.
MILES URINE CREATININE METHOD1992-08-24
HERAEUS KULZER, INC.
MILES POTASSIUM METHOD1992-08-24
HERAEUS KULZER, INC.
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)1992-07-16
HERAEUS KULZER, INC.
DURAFILL BOND1992-06-09
HERAEUS KULZER, INC.
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.51992-05-15
HERAEUS KULZER, INC.
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD1992-03-24
HERAEUS KULZER, INC.
PALAVIT G1992-03-19
HERAEUS KULZER, INC.
ENCORE1992-03-18
HERAEUS KULZER, INC.
DENTACOLOR(R) CRE-ACTIVE1992-03-11

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