FDA 510(k) clearances — page 127
clearances on record, most recent first.
Clearances — page 127
12,601–12,700 of 176,479- K223045 — 3-Ply Disposable Medical Mask
- K223077 — ViewFlex Xtra ICE Catheter
- K223281 — Disposable Nitrile Examination Glove
- K223394 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)
- K223410 — Cios Select (VA21) Flat Panel
- K221021 — Femoral Trochanteric Nail System Neonail
- K222219 — R2 Studio Q/RCT820
- K222320 — MedDream
- K222385 — Bifurcated Needle
- K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
- K222575 — HurriChem Device Kit
- K222626 — Dental Zirconia Ceramic
- K222706 — iCE-SG2 Subcutaneous Electrode Kit
- K223247 — Swoop Portable MR Imaging System
- K223386 — Optima Coil System
- K223409 — Cios Select (VA21) Image Intensifier
- K223632 — Premier's MultiMatch Universal Chameleon Restorative Composite
- K213169 — BPAP System
- K221612 — ClearRead CT
- K221806 — TruLift Lateral Expandable Spacer System & Lateral Plate System
- K222137 — OK Plus Indicator
- K222614 — Zavation Spinal System
- K222669 — Cryopush Cold Compression Device
- K222681 — Altaviz Needle Kit
- K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®)
- K222692 — BriefCase
- K223055 — Disposable Medical Face Mask
- K222019 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
- K222815 — Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
- K223004 — Disposable Nitrile Examination Gloves
- K212866 — truSculpt flex
- K222713 — White Nitrile Powder Free Patient Examination Glove, Non Sterile
- K222715 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile
- K222720 — Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
- K213465 — CardioGraphe
- K220390 — CreoDent Solidex Customized Abutment and Screw
- K220611 — SUREcore Plus Biopsy Instrument
- K220688 — SilentZPro 2.0
- K220778 — Chemical Indicator for Steam
- K221113 — Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
- K221141 — PageWriter TC35 Cardiograph
- K221401 — Self-Cath and Self-Cath Plus
- K221410 — Maestro Platform
- K221590 — NaviCam Small Bowel Capsule Endoscopy System
- K223072 — PENTAX Medical Video Esophagoscope EE17-J10
- K223211 — INHANCETM Shoulder System Humeral Stems and Stemless
- K223218 — Parietene Macroporous Mesh
- K223353 — DropSafeTM SicuraTM
- K223369 — truFreeze Console, PN CC301 +6 more
- K213768 — Bolt Navigation System
- K220786 — STAR Apollo Mapping System
- K221747 — Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
- K221791 — ProBeam 360° Proton Therapy System
- K222118 — 2-Way 100% Silicone Cleartract Catheter
- K222125 — Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
- K222297 — CentriMag Pre-connected Pack
- K222340 — Chartis Precision Catheter
- K222368 — MIST IC
- K222516 — Mercury® II Spinal System
- K222710 — IPL Cooling Hair Removal Device
- K223226 — Trigon HA Stand-Alone Wedge Fixation System
- K212717 — Paneffort AAMI Level 3 Isolation Gown
- K220254 — Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
- K221082 — Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
- K221771 — EEA Circular Stapler with Tri-Staple Technology
- K222044 — Elos Accurate Customized Abutment
- K222299 — Steripath Micro Blood Collection System
- K222305 — MissLan Digital Pregnancy Rapid Test
- K222472 — Lancing System, Sterile Lancet for Single Use, Lancing Device
- K223328 — Purgo
- K213917 — QStat Cartridge
- K213943 — SmartSurgN Visualization System
- K222408 — Disposable Safety Lancet
- K222641 — Signia Small Diameter Reloads Including Regular (Round) Tip Version
- K211050 — Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
- K220630 — TorchTM Software
- K221279 — pNOVUS 21 Microcatheter
- K221556 — T-Line Hernia Mesh
- K222363 — Aevumed PHANTOM-LP Suture Anchors
- K222611 — Male Latex Condoms
- K222652 — Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer
- K223039 — da Vinci E-200 Electrosurgical Generator
- K223099 — Facet Manatee Reusable Lancing Base
- K223274 — Momentum® MIS Posterior Spinal Fixation System
- K223009 — Wireless/Wired X-Ray Flat Panel Detectors
- K213215 — VSI HoloMedicine
- K222612 — Powder-Free Latex examination gloves
- K222918 — DentCare Aligners
- K201460 — Closed System Transfer Device
- K213459 — Glenoid Reconstruction System
- K221152 — CuringPen Dental Curing Light
- K221210 — PainShield MD PLUS
- K221815 — Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De) +1 more
- K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle)
- K222463 — EchoGo Heart Failure
- K222534 — Nitrile Patient Examination Glove
- K222569 — Ai Ray Dental X-Ray Device
- K222656 — LDE4 Lancing Device
- K222967 — Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
- K223068 — Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
Data sourced from openFDA. This site is unofficial and independent of the FDA.