FDA 510(k) clearances — page 139
clearances on record, most recent first.
Clearances — page 139
13,801–13,900 of 175,699- K212915 — MVision AI Segmentation
- K213302 — exoplan
- K213594 — ECHOLASER X4
- K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
- K220306 — ECGenius System
- K220311 — Cardiovascular Angiography System
- K220628 — LINK Endo-Model EVO Knee System
- K220791 — Surgical and Prosthetic Trays
- K221010 — Intra.Ox 2.0 Handheld Tissue Oximeter
- DEN200063 — Kerasave
- K211180 — Liver Suite
- K212348 — ALPHALOK Plating System
- K213837 — Arthrx Fracture Plates
- K213877 — ExactechGPS® System
- K220283 — TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
- K220341 — ARx Modular Spinal System
- K220243 — Ultiri Measurement System
- DEN200066 — BioFire Joint Infection (JI) Panel
- K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine
- K202977 — Alinity m STI Assay
- K211350 — Bindex BI-2
- K212422 — Disposable Surgical Isolation Gown
- K212430 — BONREE Nelaton Catheter
- K212514 — Safety Pen Needle for Single Use, Insulin Pen Needles
- K212711 — SteriTite Container System with MediTray Products
- K213334 — Monarch Platform, Urology
- K213482 — TIA Tip, Cariosity, Transillumination Accessory Tip
- K213649 — BodyTom 64
- K214045 — FreedomEdge Syringe Infusion System
- K220038 — Camber Spine Navigation System
- K220189 — LISA Laser Surgical Fibers
- K220271 — Hand Diagnostic Radiography Imaging System
- K220295 — ARIETTA 50
- K220338 — ExacTrac Dynamic
- K220383 — LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
- K220417 — Spectrum IQ Infusion System with Dose IQ Safety Software
- K220590 — aPROMISE X
- K220608 — Accu-Chek FastClix Blood Lancing System
- K220684 — Oryx Cloud Imaging
- K220695 — Elite Biomedical Solutions Dose Request Cord
- K220899 — Oxehealth Vital Signs
- K220939 — MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
- K221005 — EEA Circular Stapler with Tri-Staple Technology
- K221006 — GIA Stapler with Tri-Staple Technology
- K202691 — Ortholock Anchorage Devices
- K211713 — AngioCloud Service
- K211715 — RetinAI Discovery
- K212477 — EARP Interbody System
- K212512 — G7® Vivacit-E® Freedom® Constrained Liner
- K213278 — Planmed Verity
- K213607 — Geistlich Wound Matrix PLUS
- K213921 — Microthin Natural Rubber Latex Condom
- K220244 — DVR® Crosslock Wrist Spanning Plate (131849181)
- K220264 — EFAI RTSuite CT HN-Segmentation System
- K220536 — Digital flat panel detector
- K212441 — Philips Incisive CT
- K213040 — 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
- K213077 — Automatically Retractable Safety Syringe
- K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- K213265 — Tomey Cornea/Anterior Segment OCT CASIA2
- K220231 — GyroStim
- K220568 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- K220592 — Venus BlissMAX
- K220604 — EXTesia Introducer Sheath Set
- K220645 — Hand-held IPL device (JOVS Hair Removal Device)
- K220892 — ExsoMed INnate NanoTM Lag Screw System
- K220893 — Strados Remote Electronic Stethoscope Platform (RESP)
- K220898 — NOxBOXi Nitric Oxide Delivery System
- K210250 — SpeedCath Compact Male
- K210284 — ManaSport
- K212662 — AliveCor QT Service
- K213483 — SnapLoc Wire Lock
- K213886 — BriefCase
- K220219 — PERMALOOP Suture, PERMATAPE Suture
- K220222 — IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
- K220487 — Disposable Medical Face Mask
- K220570 — M.U.S.T. MINI Posterior Cervical Screws System Extension
- K220896 — Legion Inserts with JRNY Lock
- K213861 — CER-S
- K213925 — MyoCycle MC-2 (Home / Home + / Pro / Pro +)
- K220512 — Disposable Surgical Face Mask (M01, M02)
- K221041 — Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
- K212530 — IVX Fluid Transfer Set
- K213775 — Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves
- K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2
- K203855 — CoNextions TR Tendon Repair System
- K211123 — LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
- K212031 — F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
- K212090 — Electric Scooter
- K212400 — SONON Ultrasound Imaging System, Model: SONON 500L
- K212608 — RibFix Blu Thoracic Fixation System
- K212928 — Lorals
- K212981 — MirrorMe3D Modeling System
- K213620 — ATUSA Automated 3D Breast Ultrasound System
- K213683 — Promisemed Fine Biopsy Needle
- K213708 — ROSA® Knee System
- K213889 — PicoStar
- K213944 — HealthOST
- K220574 — HYBRID S70
- K220588 — Avanos* CORTRAK* 2 Enteral Access System (EAS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.