FDA 510(k) clearances — page 96
clearances on record, most recent first.
Clearances — page 96
9,501–9,600 of 175,620- K232144 — Sterile Products of the APTUS System
- K232150 — ZSFab Cervical Interbody System
- K232153 — Avéli
- K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
- K222772 — Oral/Enteral Syringe with ENFit connector
- K222773 — Feeding Tube
- K223167 — Spirair Nasal Septal Strap
- K223538 — Integrity Implant
- K223912 — InterCollagen® Guide
- K230415 — Cadwell Guardian
- K230588 — Aer-O-Scope Colonoscope System
- K230690 — Tandry Locking Plate System
- K230871 — EXTRON 5; EXTRON 7
- K231481 — Xpert Xpress CoV-2/Flu/RSV plus
- DEN220073 — Revi System
- K222148 — HemoScreen Hematology Analyzer
- K223479 — AQUAbase nX
- K223709 — Kyphoplasty Balloon Catheter
- K223922 — SOMNUM (V.1.1.2.)
- K230298 — Celsi Monitor
- K230314 — Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
- K230342 — Phototherapy System (OL-PDT950)
- K230577 — Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
- K230581 — TOPA12 Portable X-ray Unit
- K230832 — Powdered Free Sterile Natural Rubber Latex Surgical Gloves
- K231087 — Guided Surgery Kit
- K231389 — Harvest Dental HD Gum Strip
- K231491 — TA Stapler and Loading Unit with DST Series Technology
- K232116 — CoreLink Navigation Instruments
- K232126 — EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil
- K232141 — CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
- K223874 — BAROguard
- K231094 — Annalise Enterprise CTB Triage-OH
- K231301 — Vscan Air
- K231455 — Implant-One System
- K231583 — Route 92 Medical Full Length 054 Access System
- K231750 — MA012 Aluminum wheelchair, MS019 steel wheelchair
- K231807 — primaLOK SP Interspinous Fusion System
- K231829 — Xenix Medical Sacroiliac Fixation System
- K231838 — RxSight® Insertion Device (63002)
- 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; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
- 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); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.