FDA 510(k) clearances — page 105
clearances on record, most recent first.
Clearances — page 105
10,401–10,500 of 176,479- K232127 — 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
- K223660 — SaintView
- K230607 — SPICCA Cervical Fusion Cages
- K230608 — SPICCA Stand-Alone Cervical Fusion Cages
- K230663 — Density
- K231018 — Yomi Robotic System
- K231054 — V-Laser
- K231208 — Stryker Resorbable Fixation System
- K231341 — Organic cotton tampon, Viscose tampon
- K231418 — ENDOGATOR Hybrid Irrigation Tubing
- K231434 — DESS Dental Smart Solutions
- K231905 — Electro-Spec Steri-Caps
- K232162 — Autotome Pro RX 39 Sphincterotome +6 more
- K232311 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
- K223584 — Pre-Filled Normal Saline Flush Syringe
- K230172 — Pulse Oximeter
- K230756 — TK Pre-Filled Normal Saline Flush Syringe
- K222888 — BlueStar CGM insulin dose calculator
- K223463 — Otsuka Digital Feedback Device-RW
- K223519 — Carex Hybrid Personal Lubricant
- K223840 — eRapid Nebulizer System
- K223856 — NuEra Tight RF Family
- K230297 — PMT Expandable Cage (PMT EXP)
- K230384 — PolyWear® Personal Protective Level 3 Gown
- K230420 — Dr. pen Microneedling System
- K230626 — Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01) +3 more
- K230632 — VersiHD with GuideMe software
- K230642 — Electronic Blood Pressure Monitor
- K231408 — Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
- K231409 — Erchonia FX-405
- K231439 — Powder Free White, Black, and Purple Nitrile Examination Glove
- K231493 — NITINEX Memory Compression Staple
- K231696 — Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
- K231823 — NOxBOXi Nitric Oxide Delivery System
- K213131 — Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
- K213134 — Accu-Chek Solo micropump system with interoperable technology
- K221925 — ID NOW COVID-19 2.0
- K222850 — HAVAb IgG II
- K223445 — ArtiFascia
- K223500 — SuperBall Meniscal Repair System
- K223608 — GEM Premier 7000 with IQM3
- K223711 — ANNE One
- K230268 — ZenPro 40
- K230428 — Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2
- K230625 — ReliOn Premier BLU Blood Glucose Monitoring System
- K231380 — AirLife DuoTherm Humidification System
- K231415 — EnSite X EP System
- K231420 — Aura 10 PET/CT
- K222443 — Air Smart Extra Spirometer
- K230304 — Polyisoprene Surgical Gloves
- K231114 — Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
- K231164 — Conductive carbon film electrode
- K231167 — Conductive Silicone Rubber Electrode
- K231376 — Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
- K231394 — Intense Pulsed Light System
- K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
- K231885 — Medline UNITE® REFLEX® Nitinol Staple System
- K232039 — Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K222128 — Protective Gown AAMI Level 4
- K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- K223633 — Rubicon Control Support Catheter (H749394323506A1)
- K223924 — LW Implant System
- K230551 — Visual-ICE Cryoablation System
- K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
- K231857 — Arthrex TightRope II
- K232008 — Disposable Medical Examination Nitrile Gloves
- K232052 — Ceribell Instant EEG Headband
- K232100 — Efai Pacs Picture Archiving and Communication System Pro
- K220828 — SQA-iO Sperm Quality Analyzer
- K223476 — V-PRO maX 2 Low Temperature Sterilization System
- K223713 — Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K230376 — Reprocessed Agilis NxT Steerable Introducer
- K231098 — LineSider® Spinal System
- K231488 — Celerity HP Chemical Indicator +3 more
- K231490 — Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
- K231500 — Vis-U-All Low Temperature Sterilization Pouches
- K231501 — PRO-LITE Sterilization Tray
- K230733 — Stryker Resorbable Fixation System
- K220031 — Alinity h-series System
- K221138 — Titus Titanium Cervical by SAGICO
- K222635 — Premier Resolution System
- K223431 — Citric Complete Liquid Citric Acid Concentrate
- K223507 — CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)
- K223673 — Surgeon Controlled Arm
- K223787 — ECGenius System
- K230126 — Dentis s-Clean Regular Abutment
- K230672 — Annabella Breast Pump
- K231333 — STRETTO Cable System
- K231370 — Dewin Blastocyst Medium (with HSA and without HSA)
- K231400 — Bladeless Trocar Artemis Lap Cannula
- K231404 — T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
- K232005 — HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue) +1 more
- K232006 — LEGACY® IPC
- K232010 — iTEMPSHIELD
- DEN230003 — Viz HCM
- K221894 — Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
- K223122 — MENIX®; MENIX® DUO
- K223133 — VisiRad XR
- K223542 — TubaVent Balloon Dilatation System
- K223551 — Sterile Water for Inhalation in 1L Flexoval ® bottles.
Data sourced from openFDA. This site is unofficial and independent of the FDA.