FDA 510(k) clearances — page 146
clearances on record, most recent first.
Clearances — page 146
14,501–14,600 of 176,479- K220747 — Power Wheelchair (N5515B)
- K221001 — IPL Home Use Hair Removal Device
- K211152 — Durex Condom with Benzocaine
- K212909 — VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
- K213001 — Procedure Mask, Surgical Mask
- K213177 — Plus Medical Cover Gown
- K213299 — Wireless EEG System
- K220250 — Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
- K220446 — Versana Balance
- K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K220662 — Disposable Barrier Sleeves
- K210585 — BD CTGCTV2
- K212519 — Overjet Caries Assist
- K213004 — Needle Free Connector
- K214008 — Dental diode laser
- K220427 — White Nitrile Powder-Free Patient Examination Glove, Non Sterile
- K220428 — Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
- K220711 — SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
- K220727 — inHEART MODELS
- K221059 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
- K221136 — RadiForce MX243W
- K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
- K203527 — Immunalysis Tapentadol Urine HEIA
- K211840 — Sight OLO
- K213022 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
- K213946 — Compass BDS Biliary Stent
- K220414 — VersaCross Connect Transseptal Dilator
- K203711 — IWL2020 Blood Glucose Monitoring System
- K211021 — Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
- K211685 — Elecsys Testosterone II
- K211966 — Segment 3DPrint
- K212092 — Portable Folding Electric Wheelchair (Model: DC01)
- K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
- K212555 — Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
- K212564 — Electric Breast Pump
- K212582 — SpyGlass Discover Balloon Dilation Catheter
- K212657 — Quantum Heater-Cooler
- K213788 — TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
- K213884 — Disposable EEG cable
- K213900 — WAVi SCAN EEG System and Accessories
- K213935 — PISCES-SA Standalone ALIF Interbody System
- K213975 — KEOPS Balance Analyzer 3D
- K214072 — Masimo O3 Regional Oximeter System
- K214108 — Medline Orbis Chemo Surgical Gown
- K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
- K220269 — HM70 EVO Diagnostic Ultrasound System
- K220653 — Astroglide Glycerin & Paraben Free
- K220664 — NewTom 7G
- K220689 — Vatech Clismile
- K221046 — Invu by Nuvo
- K210411 — PosiSep EAR Fragmentable Ear Dressing
- K210565 — Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
- K211529 — NAVIRFA Scope
- K212346 — Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
- K212434 — Neuromuscular Transmission Monitor TOF3D
- K212756 — Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
- K220041 — HandPICO
- K220559 — 17HQ901G-B
- K220685 — HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
- K220691 — LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
- K220716 — Spartan SC 069
- K221013 — GIA Auto Suture Stapler with DST Series Technology
- K221016 — Steriking Packaging for Medical Devices
- K221044 — AcQGuide® VUE Steerable Sheath
- K221057 — Viatrac 14 Plus Peripheral Dilatation Catheter
- DEN200072 — Lumipulse G ß-Amyloid Ratio (1-42/1-40)
- K201302 — LiveOne
- K211036 — Plus Medical Chemotherapy Gown
- K211707 — BioTeke Sterile Disposable Virus Sampling Kit
- K212257 — Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
- K212588 — Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
- K213420 — WaveForm L System, WaveForm TO System, WaveForm TA System
- K213526 — Aurora-RT
- K213550 — HydroPICC 5F Dual Lumen Catheter
- K214065 — ROSA ONE Brain application
- K220030 — Vista Ophthalmics Vitrectomy Probe
- K220700 — Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
- K220704 — Serranator PTA Serration Balloon Catheter
- K220705 — MyKnee R Pin Positioners
- K212064 — Orchid Safety Release Valve(TM)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.