FDA 510(k) clearances — page 221
clearances on record, most recent first.
Clearances — page 221
22,001–22,100 of 176,542- K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
- K192935 — CAPERE Thrombectomy System
- K192936 — Soltus 500
- K192940 — CoolTone
- K183666 — EBA One Nailing System
- K190478 — Reprocessed ViewFlex Xtra ICE Catheter
- K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
- K190721 — LongBow Ti
- K191110 — HeraBEAT US
- K191280 — E-100 Electrosurgical Generator, SynchroSeal
- K192347 — ST Internal Implant System
- K192355 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
- K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
- K192911 — Brainlab Compatible K2M Navigation Instruments
- K191171 — EchoGo Core
- K191477 — AEON-C Stand Alone System
- K191570 — Infrared Thermometer Model MD-H30
- K191976 — Piper GO-IO Intraosseous Infusion System
- K192150 — AMICUS Separator System
- K192469 — Nox Sleep System
- K192582 — NuVasive CoRoent Small Interlock System
- K192915 — GMA 2.0 Pedicle Screw System
- K190799 — PENTAX Medical Video Upper GI Scopes (EG Family)
- K191161 — xTAG Gastrointestinal Pathogen Panel (GPP)
- K191972 — ARIX Wrist System
- K192202 — Clear21
- K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)
- K192331 — LaseMD LEO Laser System
- K192932 — FDR D-EVO III flat panel detector system
- K192968 — IDENTIFY
- K191986 — DESS Dental Smart Solutions
- K192661 — LATERA Absorbable Nasal Implant System
- K190661 — Omics Core
- K190958 — Neodent Implant System
- K182301 — PFC SIGMA Knee System
- K190998 — BA Pit & Fissure Sealant
- K191230 — Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
- K191237 — CERENOVUS Large Bore Catheter
- K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
- K191286 — CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
- K191527 — Visalys CemCore, Visalys Cem Core Try In Paste
- K191959 — QuantX Breast MRI Biopsy Guidance Plugin
- K192019 — Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.