Heraeus Kulzer, Inc.
Heraeus Kulzer, Inc. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2009.
Top product codes for Heraeus Kulzer, Inc.
Recent clearances by Heraeus Kulzer, Inc.
1–100 of 145- K091494 — FLEXITIME FLOW
- K063062 — HKBOND 2006
- K060994 — MONDIAL
- K052543 — HERACERAM ZIRKONIA
- K043504 — PALAIMPACT
- K043295 — VERSYO.DIRECT
- K042878 — FLEXITIME XTREME
- K030052 — OSTIM
- K040859 — HERACERAM PRESS
- K040043 — NDX-40 ALLOY
- K033628 — ARTIC
- K033665 — VENUS FLOW
- K033629 — VERSYO.BOND
- K030318 — P2 POLYETHER
- K022612 — IBOND GLUMA INSIDE
- K020131 — VENUS UNIVERSAL LIGHT CURING COMPOSITE
- K012341 — TRANSLUX ENERGY
- K010541 — PREVISION CHEM
- K011130 — PREMIUM
- K010800 — VERSYO.COM
- K011036 — RD-3008
- K003930 — FLEXTIME MAGNUM 360
- K000629 — FLEXTIME
- K993932 — SOLITAIRE 2
- K993602 — PRE-VISION FILL
- K992985 — GLUMA COMFORT BOND
- K992292 — GLUMA COMFORT BOND + DESENSITIZER
- K991425 — XANTOPREN COMFORT
- K990756 — FLOW LINE
- K990143 — GLUMA ONE BOND
- K981546 — NTI CLENCHING SUPPRESSION SYSTEM
- K974390 — GLUMA ONE BOND
- K973694 — PROVIL NOVO
- K971733 — 2 BOND 2
- K972101 — SOLITAIRE
- K971155 — MEMOREG
- K970848 — SILOC SYSTEM
- K964038 — CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
- K965163 — CUTTERSIL COMFORT
- K965165 — CUTTERSIL COMFORT HARDENER
- K964140 — GLUMA CONDITIONER
- K962812 — GLUMA DESENSITIZER/GLUMA 3 PRIMER
- K961995 — QUICKSPLINT
- K954929 — CHARISMA SINGLE DOSE
- K953743 — PALASPLINT
- K954115 — ARTGLASS & KEVLOC
- K951058 — GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
- K951361 — DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
- K946183 — CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
- K943780 — NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
- K940971 — AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
- K940577 — GLUCOMETER ELITE LOW CONTROL
- K936212 — GLUCOFILM TEST STRIPS
- K940800 — DENTACOLOR VITA (VS) SHADE SYSTEM
- K935735 — ATTACHMENT BOND
- K935736 — CHARISMA SUPERLIGHT
- K934386 — IMPAX 5000
- K934832 — IMPAX 3000
- K934283 — DENTALON PLUS MODIFICATION
- K934898 — GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
- K934900 — GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
- K926362 — GLUCOSTIX REAGENT STRIPS
- K930322 — FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
- K933409 — IMPAX 1000
- K926360 — GLUCOFILM TEST STRIPS
- K932034 — PALAVIT 55 AND DENTACOLOR CONNECTOR
- K926009 — MATRIX CCM 600
- K931838 — DENTHESIVE II
- K932013 — CHARISMA -- MODIFIED
- K931310 — GLUCOMETER M+ BLOOD GLUCOSE METER
- K926361 — GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
- K930685 — TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
- K930487 — PALATRAY LC MINT
- K925220 — PMI100 VIDEO IMAGER
- K930148 — TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
- K931467 — CHEK-STIX CONTROL STRIPS FOR URINALYSIS
- K930208 — CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
- K925289 — MATRIX CR 2050, PMI 3000
- K926359 — CLINITEK 200+ URINE CHEMISTRY ANALYZER
- K926144 — URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS
- K924499 — ELITE TEST STRIPS GLUCOMETER
- K925203 — TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1
- K924024 — ORTHO WAX
- K924422 — PALABOND
- K922945 — TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
- K923549 — PALADISC LC
- K923105 — MILES URINE AMYLASE METHOD
- K923018 — ENCORE TEST STRIPS
- K923258 — TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
- K923037 — MILES SODIUM METHOD
- K924129 — MILES AUTO METH DETERMIN OF URIC ACID IN URINE
- K915898 — PALADUR
- K923034 — MILES URINE CALCIUM METHOD
- K923040 — MILES URINE GLUCOSE METHOD
- K923237 — TECHNICON H*2
- K923035 — MILES URINE UREA NITROGEN METHOD
- K923036 — URINE CHLORIDE
- K923038 — MILES POTASSIUM METHOD
- K923039 — MILES URINE CREATININE METHOD
- K921939 — SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
Data sourced from openFDA. This site is unofficial and independent of the FDA.