FDA 510(k) clearances — page 1221
clearances on record, most recent first.
Clearances — page 1221
122,001–122,100 of 176,637- K912868 — GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
- K913033 — LATEX EXAMINATION GLOVES
- K905125 — GUARANTY HAIR REMOVAL SYSTEM
- K904926 — SMART-EP
- K910917 — CATHLAB SILICONE BILIARY BALLOON CATHETER
- K910926 — TECNADYNE SURGI-SQUEEZE INFUSION PUMP
- K910950 — HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED
- K911193 — OHMEDA MODEL 4700 OXICAP
- K911264 — CALIBRATION KIT
- K911520 — ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE
- K911521 — ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP
- K911567 — DUAL COMPARTMENT TPN BAG 3 LITER
- K911637 — STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD
- K911815 — 3RD HAND HELPER
- K911938 — DYNAVISION 2000
- K911964 — MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
- K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY
- K912022 — FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
- K912092 — MODIFIED LIFECARE MODEL 175 INFUSER
- K912286 — CARDIAC SPECT PALLET
- K912352 — PEACE MODEL 100 CUFF MONITOR
- K912481 — ECT CARBON FIBER PALLET, MODIFICATION
- K912555 — GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
- K912586 — TANGENT IV
- K912625 — MOUTH TO MASK RESUSCITATOR
- K912626 — BOLUS XENON CIRCUIT
- K912750 — MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR
- K912988 — LATEX EXAMINATION GLOVES
- K913000 — HEART NEBULIZER POLE CLAMP
- K911090 — OMEGA ANGIOSCOPES (OMEGASCOPES)
- K911752 — ICON TELERADIOLOGY SYSTEM
- K911896 — DEVILBISS MODEL 5000
- K911956 — ZOLL PD-1400 PACER/DEFIBRILLATOR
- K912011 — CODMAN SKULL CLAMP
- K912582 — MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
- K912870 — HEARING AID, UNITRON MODEL UIK
- K912884 — E.T. TAPE II
- K913104 — MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE
- K913233 — CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
- K904294 — QSI 9500
- K910482 — ALTA CHANNEL PLATE CONNECTOR
- K910608 — PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
- K910852 — 507 NON-INVASIVE VITAL SIGNS MONITOR
- K911302 — MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
- K911958 — CYTOCLONE A & B EIA
- K911989 — GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.
- K912051 — MEDI-THERM (MTA-5900) & DETACHABLE HOSES
- K912076 — POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF
- K912084 — MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
- K912136 — CHOLESTECH LIPID MONITORING SYS.
- K912191 — SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP
- K912194 — PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
- K912195 — PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
- K912199 — SOFTTOUCH(R) GUIDING CATHETER
- K912237 — STRYKER ECLIPSE WARMING STRETCHER
- K912291 — DISTAT ANTI-SCL-70 KIT
- K912292 — DIASTAT ANTI-JO-1 KIT
- K912346 — MEDIKEEPER
- K912423 — VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112
- K912424 — VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110
- K912434 — SALTER LABS INFANT NASAL CPAP CANNULA
- K912465 — VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121
- K912495 — IONOSEAL
- K912497 — IONOBOND
- K912587 — K-FREE
- K912596 — MECONIUM ASPIRATION
- K912603 — REP ALP-15, 8, & 4 KITS
- K912725 — TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
- K912808 — ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
- K912810 — ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
- K912831 — BACTI-SWAB(TM) II
- K912858 — LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY
- K912912 — SYNERMED SERUM IRON-600 REAGENT KIT
- K912917 — MILENIA ESTRADIOL
- K912938 — RHYTHM
- K913066 — EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
- K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE
- K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY
- K911922 — BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
- K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE
- K904723 — FORCEPS
- K904737 — GROSS HIP FEMORAL COMPONENT
- K904834 — INTAVENT LARYNGEAL MASK
- K910304 — RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
- K910839 — ULTIMATE 3000
- K910849 — SYSMEX F-810
- K910877 — FINN KNEE PROSTHESIS
- K910957 — MASTERPIECES MICRO SYSTEM
- K911154 — SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
- K911172 — SYSMEX F-610
- K911173 — SYSMEX F-310
- K911190 — PERRYMETER(TM)
- K911374 — PLASTIC OVERLAYS
- K911443 — INSUL-LINE
- K911597 — THE NEEDLE NABBER
- K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE
- K911788 — ECONOVAGE R
- K911887 — MAJOLI UTERINE MANIPULATOR/INJECTOR
- K911890 — OSTEONICS(R) PRT HIP STEM SERIES
- K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
Data sourced from openFDA. This site is unofficial and independent of the FDA.