FDA 510(k) clearances — page 465
clearances on record, most recent first.
Clearances — page 465
46,401–46,500 of 175,770- K111724 — STRAUMANN TIBRUSH
- K112400 — SMARTSHEARS
- K101986 — ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
- K102633 — BIOTEQ ANGIOGRAPHIC CATHETER
- K103489 — GE VEO RECONSTRUCTION OPTION
- K110086 — IFS PROFILE PLATES, SCREWS, AND WASHERS
- K110754 — CRYOPEN CRYOSURGICAL SYSTEM, K102214
- K111060 — MRGFUS PELVIC PA COIL MODEL 1.0
- K111116 — ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
- K111285 — AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING
- K111346 — RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
- K111622 — UNIMAX ANTI-FOG SOLUTION
- K111626 — ENDOSKELETON(R) TAS
- K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERS
- K111704 — AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
- K111759 — .DECIMAL ELECTRON APERTURE
- K111887 — CLOSUREFAST RADIOFREQUENCY CATHETER
- K112313 — TOSHIBA 3T EXTRA LARGE KNEE COIL
- K112327 — SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
- K112395 — WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
- K103132 — FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
- K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
- K110403 — PROLINK ADHESIVES (PROLINK, PROLINK SE)
- K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
- K111166 — A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
- K111462 — FIXATE TISSUE BAND
- K111505 — RTVUE CAM WITH CORNEAL POWER UPGRADE
- K111577 — MEDLINE VIAL DECANTER
- K111613 — XELIS FUSION
- K111802 — SV BRAIN ARRAY, SIEMENS 3T
- K112209 — PREFILLED CATHETER INFLATION SYRINGE
- K112310 — WONDFO METHADONE URINE TEST,OPIATE TEST
- K112329 — OMNI PATIENT MONITOR
- K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
- K102944 — CORELEADER HEMO-PAD MODEL CPII 02030
- K110637 — ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
- K111666 — EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
- K111696 — OPAL BAND CEMENT
- K111729 — PILOT SPINAL SYSTEM
- K112272 — EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K112399 — UNITE BIOMATRIX
- K111329 — NM-7000
- K111472 — HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
- K111650 — IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
- K111734 — MYSAFETY SYRINGE
- K111765 — FULL CORE BIOPSY SYSTEM
- K112245 — XTRA
- K112324 — CERALAS 980NM DIODE LASER FAMILY
- K101631 — FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
- K102933 — GEM-TONE BODY TRAINING SYSTEM
- K110429 — PROSIM 4, PROSIM 6, PROSIM 8
- K110791 — BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
- K110860 — COMP A-I-R
- K111139 — DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
- K111682 — DIGITAL RADIOGRAPHY
- K111685 — IP TEMP CEMENT
- K111810 — AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
- K112237 — MICROSUTURE ANCHORS
- K112309 — DIGITAL RADIOGRAPHY
- K103331 — VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
- K103358 — ROMA (HE4 EIA + ARCHITECT CA 125 II)
- K103808 — SAPPHIRE NC
- K110062 — MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG
- K110565 — ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE
- K110729 — ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
- K110944 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K111059 — GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
- K111143 — POLY-CHEM 90 TOTAL BILIRUBIN
- K112199 — XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
- K112213 — VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
- K112311 — ALP 501 RB PUMP SYSTEM
- K112349 — VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
- K112421 — EMG SUCTION UNIT
- K101204 — MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
- K101635 — TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
- K111032 — CMC CABLE FIX
- K111314 — MORPHEUS OX
- K111742 — MDRIVE
- K111913 — CAPSURE(R) PS SYSTEM
- K112239 — STEERABLE GUIDE CATHETER
- K112376 — S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
- K101543 — TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
- K110129 — RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
- K110289 — FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
- K111236 — INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
- K111308 — ZYTO HAND CRADLE
- K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEM
- K111548 — WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
- K111817 — PALINDROME RT CHRONIC CATHETER
- K111942 — TSRH SPINAL SYSTEMS
- K112029 — ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
- K112163 — MONICA IF24
- K083577 — HARMONIE SYSTEM
- K091960 — VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
- K103308 — AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
- K103799 — INQU PASTE MIX PLUS
- K110648 — NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
- K110756 — BLUEPHASE STYLE
- K111172 — 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.