FDA 510(k) clearances — page 147
clearances on record, most recent first.
Clearances — page 147
14,601–14,700 of 176,479- 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)
- K220840 — 1 Series Phototherapy Equipment
- K220895 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
- K210183 — Waterlase iPLus
- K212158 — HydroMARK Breast Biopsy Site Marker
- K212277 — Tempo Tampon
- K212737 — INHANCE Reverse Shoulder System
- K213452 — GEMS-H
- K213559 — FEMTO LDV Z8 Femtosecond Surgical Laser
- K213681 — Ivory Glove Powder-Free Nitrile Examination Gloves
- K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
- K213795 — Videa Caries Assist
- K220175 — GM85
- K220382 — Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
- K220605 — Venus Bulk Flow ONE
- K212022 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K213484 — SmoothCool HR System
- K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2)
- K220543 — Auxo A300, A150 and APod
- K220866 — EKOS+ Endovascular Device
- K220872 — Saberscope5 Laparoscope
Data sourced from openFDA. This site is unofficial and independent of the FDA.