FDA 510(k) clearances — page 417
clearances on record, most recent first.
Clearances — page 417
41,601–41,700 of 176,542- K130795 — TITAN
- K130877 — EXPEDIUM SPINE SYSTEM
- K130894 — XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM
- K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
- K121045 — HUMAN ALBUMIN CSF KIT
- K122567 — JOULE 810/940/980 MULTI-PLATFORM SYSTEM
- K123007 — VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
- K130337 — RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
- K130564 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
- K130566 — BASIXTOUCH
- K130695 — Z5 DIAGNOSTIC ULTRASOUND SYSTEM
- K130774 — UNIVERSAL DISTAL RADIUS SYSTEM
- K130819 — CLL- V1 LIGHT SOURCE
- K131267 — VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
- K131395 — TRANSTEK BLOOD PRESSURE MONITOR
- K131443 — COALIGN INNOVATIONS ACCULIF XL IBF CAGE
- K122820 — VIKY UP
- K123016 — VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
- K123087 — TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
- K123144 — VIVO 50
- K123253 — IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
- K130050 — TITAN REVERSE SHOULDER SYSTEM
- K130298 — BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
- K130499 — IU22 DIAGNOSTIC ULTRASOUND SYSTEM
- K130545 — MULTI LEAD TRIAL CABLE
- K130563 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
- K130927 — DURABLUE STERILIZATION WRAP
- K131153 — EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
- K131193 — ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
- K131445 — OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
- K122715 — STELLAR 150
- K122809 — Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
- K123431 — DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
- K123590 — VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
- K123793 — SOFIA STREP A FIA
- K130309 — RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
- K130577 — AZUR PUSHABLE 18 & 35 SYSTEM
- K130414 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
- K121214 — ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
- K121284 — CHABNER XRT GARMENTS
- K121343 — MODULAP LOOP
- K121618 — BEL-GEN COLD STORAGE SOLUTION
- K122551 — PROVITEMP
- K122950 — LASER HELMET
- K123127 — VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
- K123810 — PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
- K124018 — AMIA AUTOMATED PD SYSTEM
- K130193 — FRAXEL DUAL 1550/1927 LASER SYSTEM
- K130443 — I-MAX TOUCH 3D
- K130542 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
- K130801 — DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
- K130867 — ENFLOW IV FLUID WARMER INSULATED STRAP
- K130902 — EMORY CARDIAC TOOLBOX 3.2
- K130912 — OMNICUT RESECTION BLADE
- K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
- K130995 — NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
- K131291 — TORC BODY
- K131569 — PG-800A SERIES
- K122449 — ENTERAL NUTRITION WARMER
- K130015 — SHASER V-MINI HAIR REMOVAL SYSTEM
- K130104 — GUIDEWIRE, PURSUER SERIES
- K130380 — ORTHOSENSOR KNEE BALANCER
- K130630 — PLATEAU SPACER SYSTEM TITANIUM
- K130753 — STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
- K130787 — QUANTUM DENTAL IMPLANT SYSTEM
- K131237 — PIPELINE TOTAL HIP SYSTEM
- K122588 — VUSION CS PLUS
- K122973 — AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
- K123261 — EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
- K130191 — MINT
- K130416 — NEXUS TKO-6P LUER ACTIVATED DEVICE
- K130642 — SMR 3-PEGS GLENOIDS
- K130690 — Z-800 INFUSION SYSTEM
- K122521 — PREVENT SEAL
- K122748 — ENGLER 25K SERIES ULTRASONIC INSERTS
- K123292 — T3
- K123520 — MAMMOMAT INSPIRATION PRIME
- K130025 — SONENDO ENDOTHERAPY SYSTEM
- K130503 — PATHASSIST LED LIGHT FIBER
- K130567 — DR LONG LENGTH IMAGING SOFTWARE
- K131303 — DISPOSABLE CIRCULAR STAPLER
- K131528 — NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
- K120892 — DISPOSABLE 330PSI EXTENSION LINES
- K124023 — STARBAND
- K130907 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
- K131380 — ACUMED TOTALW RIST FUSION PLATING SYSTEM
- K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
- K123105 — XGEO GU60
- K123576 — IMR SOFTWARE APPLICATION
- K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
- K130185 — 4WEB OSTEOTOMY BONE WEDGE
- K130259 — BEARING NSPVA EMBOLIZATION PARTICLES
- K130446 — FASTBRACES CERAMIC BRACKETS
- K130464 — CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
- K130636 — TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
- K130726 — DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
- K130791 — PRELUDE SHEATH INTRODUCER
- K130944 — ISR'OBOT MONA LISA
- K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
Data sourced from openFDA. This site is unofficial and independent of the FDA.