FDA 510(k) clearances — page 174
clearances on record, most recent first.
Clearances — page 174
17,301–17,400 of 176,479- K203019 — LF900
- K203720 — MICROMATE
- K210161 — AnyOne Onestage Implant System
- K210840 — Disposable Surgical Mask
- K210881 — M Series Phototherapy Equipment
- K210882 — MolecuLight I:X
- K211215 — SenoBright HD
- K211272 — ICOONE Laser Med (also referred to as ICOONE Medical laser)
- K193301 — coDiagnostiX
- K201737 — Posterior Spinal Fixation System
- K202085 — Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
- K202855 — Orthodontic Facemask
- K202902 — 2430MCA with Xmaru W
- K210375 — Powder Free Blue Nitrile Examination Glove
- K210457 — 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key
- K210855 — Straumann BLX Implant System
- K210866 — Steri-Dot Process Indicator
- K210899 — LINK Embrace Shoulder System- Anatomical Configuration
- K211250 — VisionPort System
- K202893 — Transcutaneous Electrical Nerve Stimulator
- K202964 — iBed Wireless with iBed Mobile
- K210220 — Kontact Dental Implant System
- K210430 — Intravascular Extension Set
- K210495 — Port Access System
- K201314 — Restor3d Utility Wedge
- K201744 — Su2ura Approximation Device
- K202440 — Infrared Thermometer
- K202806 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
- K203514 — Precise Position
- K210281 — Fist Assist Devices Model FA-1
- K210364 — Migraine Tens Digital Pain Reliever
- K210700 — NaviNetics D1 Stereotactic System
- K210883 — aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
- K210886 — MIS Lance+ Conical Connection Dental Implant System
- K211535 — Sonata Transcervical Fibroid Ablation System 2.2
- K193604 — Aptiva Celiac Disease IgA Reagent
- K202718 — Qmenta Care Platform Family
- K203200 — Disposable Medical Surgical Face Mask
- K210034 — EnsoSleep
- K210694 — Silent Nite Sleep Appliance with the Glidewell Hinge
- K210920 — iBOT Personal Mobility Device (iBOT PMD)
- K211044 — Sublime Radial Access 018 RX Dilatation Catheter
- K211310 — AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
- K211336 — Disposable Vinyl Examination Glove
- K203244 — CellChek 20 rc
- K210595 — SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
- K211520 — Amerishield Surgical Mask
- K200466 — Manual Wheelchair (Model W28)
- K201397 — Ultrasonic Mesh Nebulizer
- K202813 — URO-TOUCH 9 French Probe
- K203400 — Corrugated tube with mouthpiece accessory
- K203850 — CATS®-D Tonometer Prism
- K210518 — Surgical Face Mask
- K210814 — Coconu Water Based Personal Lubricant
- K211101 — E-Temp
- K211136 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
- K211518 — 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
- K210401 — Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K202714 — Medical Face Mask
- K202766 — EOS Air Cleaner
- K203030 — POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K203215 — Radius T wearable thermometer
- K203569 — Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
- K203732 — Surgical Face Mask
- K203818 — Replens Long-Lasting Vaginal Moisturizer
- K210021 — Axon Therapy
- K210484 — LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
- K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
- K210504 — PANAVIA Veneer LC
- K210756 — Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
- K201493 — Spirometer
- K203629 — IDx-DR
- K203756 — Disposable Surgical Mask
- K203779 — Symmetric Total Knee System
- K210015 — Surgical Face Mask
- K210335 — Blood Administration Set
- K210416 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
- K210522 — Disposable Vinyl Examination Gloves
- K210699 — Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System
- K210767 — Surgical Masks, Model:FE-1
- K210972 — H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two
- K210986 — H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit
- K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
- K211459 — syngo.via MI WorkFlows, Scenium, syngo MBF
- K211469 — Callaly Tampliner
- K211590 — Fiducial Marker
- K203815 — ELEOS Limb Salvage System with BioGrip
- K210591 — Palm Bladder Scanner - PBSV7.1
- K211216 — Vivid S60N / Vivid S70N
- K211441 — Navigated Anterolateral Disc Prep Instruments
- K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
- K202126 — Disposable Surgical Mask
- K210458 — OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
- K211062 — Medical Face Mask
- K211476 — ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
- K193383 — SnugKap
- K201914 — HRVWatch-Mini Wrist Monitor
- K202580 — Disposable Surgical Mask
- K202663 — Suture Wing
- K203802 — X-Pac Expandable Lumbar Cage System
Data sourced from openFDA. This site is unofficial and independent of the FDA.