FDA 510(k) clearances — page 1018
clearances on record, most recent first.
Clearances — page 1018
101,701–101,800 of 176,637- K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES
- K944351 — SMARTDOSE IV PREFILLED INFUSION CONTAINER
- K944352 — SMARTDOSE III INFUSION CONTAINER
- K946319 — INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
- K946345 — INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
- K952219 — SUCTION TIP CLEANER CUP
- K953912 — JACOBYSCOPE
- K954025 — SIME SURGICAL POWDERFREE
- K954051 — SIME POWDERFREE PLUS
- K954077 — UNITRAX V40 MODULAR ADAPTOR
- K954348 — GLANZ CARCINOMA GAUGE, KSEA
- K954433 — VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
- K954491 — HYDROCELL NASAL AND SINUS PACKS
- K954662 — THERMALASTIC/TRIPOLYVINALENE
- K954795 — AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
- K954837 — DW260 19
- K954876 — AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA
- K954880 — LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
- K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT
- K940001 — PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)
- K945376 — DOC'S PROPLUGS EAR PLUGS
- K945578 — NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
- K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
- K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
- K951650 — CLINICAL PROTON SPECTROSCOPY OPTION
- K951685 — AURAFLEX TESTOSTERONE CALIBRATOR PACK
- K951723 — GE B510 TRANSDUCER
- K952063 — XXL BALLON DILATATION CATHETER
- K952565 — LYOFOAM EXTRA
- K952682 — LOKKI DT
- K952898 — GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
- K952901 — THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR
- K952902 — THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR
- K952932 — THE TULIP COMPANY BRANSON #1 ELEVATOR
- K952951 — THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR
- K952953 — THE TULIP CXOMPANY BRANSON #2 ELEVATOR
- K952958 — THE TULIP COMPANY BRANSON OVERSHEATH
- K953095 — PHILIPS EASYVISION
- K953362 — PREMIER EHEC
- K953621 — EVT-3300
- K953780 — ACCESS ALLERGEN DOG EPITHELIM
- K953794 — SHARPLAN LASERS, INC. SURGICAL DIODE LASER
- K953883 — ACCESS LOW LEVEL IGE CONTROLS
- K954106 — THERATEST LAB, INC., EL-ANASCR KIT
- K954127 — BIOFEEDBACK DEVICE
- K954225 — MED-TEC HAND GRIP
- K954355 — ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION
- K954449 — ENT PACKINGS, WICKS, WIPES, AND SPONGES
- K954507 — RETROGRADE KNIFE
- K954508 — RETRACTOR
- K954509 — PROBE KNIFE
- K954510 — RRIANGLE KNIFE
- K954734 — THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
- K954851 — BIOPOLAR FORCEPS LINE
- K954857 — COMFEEL:ALGINATE FILLER
- K954919 — MEROCEL SOFT WOUND DRESSING
- K955043 — WELCH ALLYN BI-OTOSCOPE
- K940188 — PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
- K950513 — ARCHIVEMANAGER
- K951081 — OB/GYN PACKS
- K951262 — OPERATING ARM SYSTEM (OAS)
- K951830 — ADVANTAGE SIM
- K951943 — CHROM Z CHROMOGENIC ASSAYS
- K952292 — PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
- K953499 — AXSYM METHADONE
- K953603 — HEARING TODAY HEARING AID
- K953894 — SIEMENS MULTILEAF COLLIMATOR
- K953909 — SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER
- K953939 — QUINTEST
- K954017 — ASSERACHROM FREE PROTEIN S KIT
- K954040 — ASSERACHROM TOTAL PROTEIN S KIT
- K954149 — ASPECT DIGITAL FORMATTER
- K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE
- K954336 — ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)
- K954337 — GENOTROPIN MIXER
- K954569 — IMMULITE THEOPHYLLINE
- K954794 — OTICON
- K954937 — COAST HEARING CHS (CUSTOM HEARING SYSTEM)
- K945476 — HEARTHWATCH III(TM)
- K946018 — TENS-IT, FITTRONIC II, (MORE LATER)
- K950986 — NEUROREADER
- K951329 — IMMUCHEM GAL-MW EA
- K951681 — QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
- K952478 — BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
- K953671 — ORGEN TEC ANTI-DSDNA ELISA ASSAY
- K953730 — CODMAN ANTERIOR CERVICAL PLATE SYSTEM
- K953815 — 5 LPM OXYGEN CONCENTRATOR
- K953829 — SAFE-T-SEAL
- K954174 — DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]
- K954175 — DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]
- K954201 — BUONAFEDE PNEUMATIC SLEEVE
- K954323 — MAS LIQUID URINALYSIS CONTROL
- K954465 — FMS DUO
- K954612 — ABL SYSTEM 625, 615, 605
- K955094 — EXAMINATION PAD
- K920633 — PESSARY FLEXIBLE SILICONE NICHOLS
- K942029 — ARTHROSCOPE
- K946166 — FIRST CHOICE(TM) TEST STRIP
- K946374 — KIMONO MICROTHIN
- K950628 — FIRST CHOICE TEST STRIP
Data sourced from openFDA. This site is unofficial and independent of the FDA.