Heraeus Kulzer, Inc.
FDA 510(k) medical device clearances.
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.