FDA 510(k) clearances — page 213
clearances on record, most recent first.
Clearances — page 213
21,201–21,300 of 175,699- K192049 — Oryx Cervical Plate System
- K192118 — CRP Vario
- K192232 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
- K192264 — HIVOX Spopad EMS SP-911, SP-921
- K192297 — APTUS Wrist Arthrodesis Plates
- K192403 — VK100 Percutaneous Vertebral Augmentation System
- K192432 — IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
- K192819 — OEC Elite
- K190571 — StoneBite and StoneBite scan
- K190872 — BioGenesis Fertility Lubricant
- K190923 — Salem Sump Dual Lumen Stomach Tube with ENFit Connection
- K191026 — MEDIP PRO
- K191361 — DemeDIOX Barbed Absorbable Surgical Suture
- K191466 — SandShark Injectable Anchor (SIA) System
- K191564 — Progenikine Concentrating System 25 mL System
- K192153 — Portux CAD/CAM Disc
- K192181 — PRECICE Plating System
- K192327 — DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
- K192632 — DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
- K192871 — B. anthracis Real-time PCR Assay
- K192891 — Laparoscope Lens Shield Device (LENS)
- K192948 — EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
- K182463 — Silicone Foley Catheter
- K182929 — BIO-RAY A-1 Anchor Screw System
- K190003 — Vivid Aligners
- K190268 — Hydrofera Blue READY - Border
- K190335 — GSP Neonatal Total Galactose kit
- K191651 — Arthrex Nano SwiveLock Suture Anchor
- K191891 — SOMATOM X.cite
- K191914 — Thermo Scientific Sensititre ARIS HiQ System
- K191918 — Thermo Scientific Sensititre ARIS HiQ System
- K192198 — Conformis Hip System
- K192729 — Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
- K183457 — Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
- K190144 — MucoPEG
- K190225 — TAP Blood Collection Device
- K190541 — MTS225 and MTS300 Multiple Tray Sterilization Systems
- K190868 — Cleerly Labs
- K191047 — ADI TiDAL Osteotomy Wedge
- K191292 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K192080 — iASSIST Knee System
- K192109 — KOALA
- K192140 — 7D Surgical System
- K192236 — Fitmore Hip Stem
- K192858 — A1AT Genotyping Test
- K192992 — Suglue 3
- K190013 — WellDoc BlueStar
- K190143 — LARS AC Band Device
- K190330 — DRX-Evolution/Plus with Dual Energy
- K190608 — Mei Ceramic Bracket
- K191160 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- K191304 — EthanZir Zirconia
- K191634 — Scan Abutments and Comfort Caps
- K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
- K192168 — Idys ALIF ZP 3DTi
- K191974 — NuVasive AttraX Putty
- K183465 — Allcem, Allcem Core
- K192824 — Parcus Knotless AP Suture Anchors
- K181993 — STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
- K183018 — VPro5
- K190119 — Foryou NPWT Dressing Kit
- K190189 — MDT2 BLE Self-Monitoring Blood Glucose System
- K190190 — WV1 Endoscope
- K190334 — MIMOSA Imager
- K190344 — DePuy Corail AMT Hip Prosthesis
- K190544 — XIHPOS ZFUZE Interbody Fusion System
- K190855 — BD Acute Central Line
- K190898 — Sight OLO
- K191016 — COPAL exchange G Hip and Knee Spacers
- K191312 — Perfect PFE
- K191497 — NextDent Denture 3D+
- K191597 — Stealth Autoguide System, Midas Rex Legend Depth Stop System
- K191622 — Delta Multihole TT Pro Acetabular System
- K191631 — ZMAXX Dental Zirconia Blanks
- K191650 — LEGION System
- K191693 — BC-5
- K192087 — Combo Electrotherapy Device
- K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera
- K192117 — Small VBR
- K192278 — Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
- K192440 — FDR SE Lite
- K183412 — mediCAD Web
- K190047 — StimRouter Neuromodulation System
- K190281 — Ultrasonic Surgical System
- K190747 — Claritag
- K191002 — OR3O Dual Mobility System
- K191769 — ePM Series Patient monitors
- K191896 — Belimed Steam Sterilizer MST-H TOP 5000
- K192110 — Vitek Densichek
- K192345 — MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
- K192525 — 087 Balloon Guide Catheter System
- K192743 — VisionX 2.4
- K192867 — Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
- K192961 — ADH19
- K190267 — EZE SIT Valvulotome
- K190921 — Arthrex Low Profile Screws
- K191134 — IB3D ALIF
- K191170 — Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
- K191264 — Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)
- K192083 — Okami Medical LOBO Vascular Occlusion System
Data sourced from openFDA. This site is unofficial and independent of the FDA.