FDA 510(k) clearances — page 478
clearances on record, most recent first.
Clearances — page 478
47,701–47,800 of 176,542- K111531 — RHA2020
- K111601 — HERO
- K111851 — MEDIOSTAR NEXT
- K101381 — HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
- K102815 — SURELIFT PROLAPSE SYSTEM
- K103714 — ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
- K110044 — FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
- K110696 — NEURO CHECK DEVICE WITH IO-FLEX WIRE
- K111194 — APNEA RISK EVALUATION SYSTEM (ARES)
- K092688 — FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
- K110280 — REVLOK FENESTRATED SCREW SYSTEM
- K110541 — FIGURE 8 STERNOTOMY CLOSURE DEVICE
- K110994 — PARKER 500
- K111012 — SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
- K111326 — OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
- K111569 — PLATEAU SPACER SYSTEM
- K111571 — VIPER SYSTEMS
- K111619 — MODIFIED CONCENTRIC MICROCATHETER
- K110809 — WIRELESS MONITORING SYSTEM
- K110880 — VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
- K110925 — NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
- K111215 — ASCOM MOBILE MONITORING GATEWAY (MMG)
- K111259 — SV DBS VRAIN ARRAY
- K111596 — TOTAL SHOULDER SYSTEM
- K101306 — SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
- K102648 — ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
- K102719 — ATLANTEAN TRIGGER NEBULIZER
- K102786 — WELL-LIFE OTC EMS SYSTEM
- K103563 — PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
- K103776 — XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
- K110300 — SIMPLANT 2011
- K110643 — MERIT MARQUIS FLOW SWITCH
- K110682 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
- K110897 — CORTEX CO2 / ER:YAG LASER SYSTEM
- K110940 — ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
- K111025 — TRIGEN LOW PROFILE BONE SCREW
- K111029 — FORA POCT MANAGMENT SYSTEM
- K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
- K111179 — ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
- K111226 — ENDOSCOUT TRACKING SYSTEM
- K111546 — U2 HIP SYSTEM
- K102177 — SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
- K102573 — PROVU (TM) DENTAL X-RAY SYSTEM
- K102813 — EZONO 3000
- K102856 — SIROCCO THERMAL REGULATING SYSTEM
- K103234 — GC AADVA BO AC ABUTMENTS
- K103655 — OCTANE-C INTERBODY FUSION DEVICE SYSTEM
- K110650 — ZYSTON ARC INTERBODY SPACER
- K110839 — SCANORA 3D
- K110886 — CLIO/CLIOSOFT
- K110967 — ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
- K111107 — SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
- K111117 — CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
- K111148 — S8 ASPEN WITH H4I PLUS
- K111219 — GMD UNIVERSAL URINARY INCONTINENCE SLING
- K111485 — FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
- K111488 — MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
- K111498 — FATHOM (TM) 14 STEERABLE GUIDEWIRE
- K111674 — ACUSON
- K103495 — ASICO SOFTIP INJECTOR SYSTEM
- K110099 — PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS
- K110223 — WAVEGUARD (TM) EEG CAP
- K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
- K111046 — CORIN MINIHIP FEMORAL STEM
- K111672 — MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER
- DEN100017 — LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
- K101692 — PATIENT MONITOR
- K103417 — HALIFAX BIOMEDICAL TANATLUM BEAD SET
- K103807 — IVAS 2-10MM (10 GUAGE) BALLON CATHETER
- K110035 — INDIKO
- K110243 — MEDART DIODE LASER SYSTEM & ACCESSORIES
- K110695 — BIPOLAR HF DEVICE
- K110712 — DRYTOUCH SUCTION STIMULATOR PROBE
- K110752 — HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
- K110908 — APTUS FOOT 3.5 SYSTEM
- K111063 — VITAL SERUM CONTROLS
- K111180 — VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
- K111340 — HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
- K111658 — AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
- K101509 — U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
- K110950 — CONSENSUS KNEE SYSTEM
- K110968 — PROFLU+ ASSAY
- K111193 — APEX ARC HIP STEM
- K102771 — BIOPSY HANDY, MRI BIOPSY HANDY
- K103520 — CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
- K110344 — INOMAX DSIR (DELIVERY SYSTEM)
- K110459 — SUREFIRE INFUSION CATHETER SYSTEM
- K110518 — IBAG
- K110545 — SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
- K110566 — VIBERECT PENILE VIBRATORY STIMULATION DEVICE
- K110609 — EPIDUCER LEAD DELIVERY SYSTEM
- K110630 — F10
- K110684 — MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
- K110704 — SENSI
- K110730 — MONACO RTP SYSTEM
- K110900 — DISPOSABLE THYROID COLLAR
- K111091 — MERIT MEDICAL 20 ML SYRINGE
- K111096 — VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
- K111133 — NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
- K111233 — SUPRIS RETROPUBIC SLING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.