FDA 510(k) clearances — page 132
clearances on record, most recent first.
Clearances — page 132
13,101–13,200 of 176,479- K221172 — FOCUS Interbody System
- K221305 — AI-Rad Companion Organs RT
- K221447 — Southern Anterior Screw Fixated Cage (SASCA)
- K221501 — syngo.via View&GO
- K221504 — BD Surgiphor Antimicrobial Irrigation System
- K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
- K221858 — ZSFab Lumbar Interbody System
- K221886 — Sublime Microcatheter
- K222284 — Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
- K222407 — 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
- K222537 — IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
- K222662 — Vitrea CT Cardiac Analysis
- K222797 — X-Pac Expandable Lumbar Cage System
- K211321 — Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
- K211427 — CREOKORREKT Aligners
- K212702 — IM/ST Fixture System
- K213396 — SPIFE A1AT kit
- K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters
- K220805 — VITEK 2 AST-Gram Positive Cefoxitin Screen
- K220853 — PicoWay Laser System
- K220857 — X-CUBE 50, X-CUBE 60
- K221770 — Fiber Laser Treatment System
- K221857 — Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
- K221989 — The Oligio
- K222081 — ID-510 iRestore Elite
- K222087 — SCIg60 Infusion System
- K222113 — Abiomed 14Fr Low Profile Introducer Set
- K222448 — UNITY Sacroiliac Joint Fixation System
- K222473 — EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods
- K222763 — Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
- K203638 — AT-Patch ECG Analysis System
- K211872 — PiezoImplant System
- K213120 — OW100S (model OW100S-US)
- K220102 — MOST-T Autoclave
- K220227 — Auto Folding Scooter, S21F
- K220911 — Elecsys CMV IgG
- K220923 — Elecsys HSV-1 IgG (08948844160)
- K220924 — Elecsys HSV-2 IgG (08948887160)
- K221263 — Aqua Naina Plus Sterile Saline Solution
- K221510 — TrusFIL-Flow Flowable Composite Restorative
- K221576 — Ameda Pearl Electric Breast Pump
- K221712 — Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
- K221913 — Arm Blood Pressure Monitor
- K222064 — The Alma Soprano Titanium
- K222068 — Durex Penck III Regular
- K214116 — AAMI4 Isolation Gown
- K220169 — SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
- K221830 — Apyx One Console
- K221951 — Branchor Balloon Guide Catheter
- K222079 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K222157 — ECHO Photocoagulator
- K222335 — Surgical Mask
- K222432 — IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
- K222435 — Renamel® Microhybrid; Renamel® Flowable Microhybrid
- K222744 — Sol-M Luer Lock Syringe
- K223008 — Disposable Vinyl Examination Gloves
- K202163 — Mico One Orthodontic Screw
- K213061 — SuperCheck Pro Blood Glucose Monitoring System
- K213610 — Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
- K213969 — VisionAir Patient-Specific Airway Stent
- K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
- K220092 — YADU Surgical Gowns
- K220111 — RespiraSense
- K220156 — Electrically Powered Wheelchair, Joy Rider
- K220256 — MIM-Ablation
- K220267 — AMSafe NeuFlo Needleless Connector
- K220709 — BriefCase
- K221154 — Infant Heel WarmerTM; Heel Snuggler®
- K221170 — Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
- K221310 — Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
- K221492 — SteriTite Container System with MediTray Parts
- K221498 — Miha Bodytec II
- K221575 — Pre-Formed Blue
- K221764 — InBody Blood pressure monitor, Model BPBIO480KV
- K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur
- K222028 — IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System
- K222205 — Cold Sore Device (Model: QPZ-01)
- K222369 — PURE Laser
- K222418 — Nuvola
- K222424 — Protect-It Custom Fit Dental Guard
- K222698 — CUVIS-spine
- K222714 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
- K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
- K212168 — A&D Medical UM-212BLE Blood Pressure Monitor
- K213666 — NuCath Wedge Pressure Catheter
- K220365 — Gemini Sterilization Wrap
- K220852 — iCare IC200
- K221449 — Genius AI Detection 2.0
- K221653 — InfaTherm Disposable Infant Warming Mattress
- K221889 — ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
- K222080 — Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
- K222427 — PRIMA TT Glenoid
- K222431 — b-ONER MOBIO Total Knee System
- K222686 — Perfit FS Dental Zirconia Fully Sintered Block
- K222700 — Tibial baseplate, Tibial insert
- K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
- K220138 — Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
- K220140 — ClearCorrect System
- K220546 — Colibrí System
- K221128 — Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
Data sourced from openFDA. This site is unofficial and independent of the FDA.