FDA 510(k) clearances — page 282
clearances on record, most recent first.
Clearances — page 282
28,101–28,200 of 175,699- K171870 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 ug/mL
- K171906 — Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
- K171975 — HardyDisk AST Delafloxacin 5 µg (DLX5)
- K161845 — Electronic Blood Pressure Monitor
- K163127 — bellavista 1000
- K163136 — Youha electric breast pump
- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K170207 — Obturys
- K170842 — WEGO-PTFE
- K171040 — Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
- K171132 — Carefusion NeutraClear Needle-free connector
- K171301 — Scanmate Flex
- K171588 — NuBODY Skin Toning Device
- K171607 — Bronchi and Gastrointestinal Cytology Brush
- K171615 — Xingyu Nitrile Powder Free Patient Examination Gloves, White color
- K171623 — Nasal Pancreatic Drainage Set
- K171999 — Performer Introducer
- K172025 — Litho 60
- K162951 — TUBETECH IV Administration Set
- K163048 — Smart Stitching Software System, Image Processing, Radiological
- K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- K163259 — AXS Offset Delivery Assist Catheter
- K163352 — Wheelchair
- K163633 — cobas HbA1c Test, cobas b 101 system
- K170187 — Photodynamic Therapy Device
- K171054 — Biomet Knee Joint Replacement Prostheses
- K171103 — Lumipulse G TSH-III Immunoreaction Cartridges
- K171265 — Otowave 302 Portable Tympanometer
- K171602 — Williams Cystoscopic Injection Needle
- K171699 — da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
- K171754 — NovaPACS
- K171945 — Discovery Pico, Discovery Pico Plus
- K172013 — VitalBeam
- DEN150053 — FETAL PILLOW
- K162816 — SML-OSA2 Appliances
- K163005 — TIGR Matrix Surgical Mesh
- K163031 — Bunegin-Albin Air Aspiration Set
- K163597 — VacLok AT Vacuum Syringe
- K170313 — ARIX Ankle Distal Tibia System
- K170563 — 3M Comply Hydrogen Peroxide Indicator Tape
- K171282 — Fully Automatic Blood Pressure Monitor
- K171423 — Nasal Alar SpO2 Sensor
- K171905 — VISCO 360 Viscosurgical System
- K172041 — truFreeze System
- K162867 — MagDen Dental Implant System
- K163400 — Orbit Inserter
- K163536 — MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
- K170769 — wireless thermometer
- K170812 — HygePLUS Alginate Impression Material
- K170841 — BiopSee, Mobile US
- K171515 — NHAC 16
- K171727 — Hydrocleanse Antimicrobial Skin and Wound Care Solution
- K162312 — Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
- K163062 — PHMB Antimicrobial Foam Wound Dressing
- K170067 — Easyret
- K170073 — LightMed Dental Laser System
- K170305 — Spinal Manometer NRFit; Spinal Manometer LUER
- K170388 — ANCHORMAN Tibial Ligament Fixation Device
- K170600 — CARTO 3 EP Navigation System, Version 6.0 and Accessories
- K170770 — CT Midline
- K170867 — FTRD System Set
- K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
- K171255 — Monteris Medical NeuroBlate System
- K171630 — LumFuse-TP
- K171645 — CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
- K171734 — HP PRO Positioning Device
- K171837 — TomoTherapy Treatment Delivery System with iDMS
- K171885 — Radiance V4
- K171913 — Rubicon 14, 18 and 35 Support Catheters
- K171967 — MagVita TMS Therapy System
- K162633 — Custom Bars
- K162858 — NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
- K162991 — YELLOW 560 Fluorescence Module
- K163295 — Infant Transport Mattress Warmer with Disc
- K163486 — DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates
- K170923 — JAWS(TM) Nitinol Staple System
- K171285 — ARIX Diaphysis System
- K171364 — MP LeFort I Plates
- K171559 — True Spinal Fixation System
- K171724 — Rampart L Lumbar Interbody Fusion Device
- K171962 — Klassic HD® Hip System
- K162950 — VITEK MS
- K152257 — Fujifilm Duodenoscope Model ED-530XT
- K161527 — Teco Creatinine Enzymatic Reagent Kit
- K162778 — Portable Slit Lamp Microscope
- K163232 — Vitrea View
- K170223 — Progreat
- K170532 — True Form Reshapable Guide Wire
- K170832 — Ultimax-i, DREX-UI80 V1.60
- K171003 — 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
- K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
- K171597 — Vantage Elan 1.5T, V4.0
- K171753 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
- K171855 — External Moisturizing Gel
- K162219 — CADD® Infusion Disposables Portfolio with NRFit connectors
- K163025 — DORA Disposable A.V. Fistula Needle Sets
- K163589 — SIGN IM Nail
- K170219 — Microlife Digital Infrared Ear Thermometer
- K170326 — dynaMX Intramedullary Implant
- K171425 — CONCORDE LIFT
Data sourced from openFDA. This site is unofficial and independent of the FDA.