FDA 510(k) clearances — page 121
clearances on record, most recent first.
Clearances — page 121
12,001–12,100 of 175,620- K203035 — Eonis SCID-SMA kit
- K220334 — MONET Anterior Cervical Plate System
- K221539 — GammaTile
- K221855 — Universal CMF System
- K222162 — Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
- K222166 — SOLIX
- K222198 — Exo Iris (El2001)
- K222497 — Zaga Zygomatic System
- K222754 — ViewMate Multi Ultrasound System
- K223132 — Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
- K203812 — Oxyfit Pulse Oximeter
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
- K221552 — EFAI ChestSuite XR Pneumothorax Assessment System
- K222132 — Hisense LCD monitor HMD2G21S, HMD3G21S
- K222304 — Sonata Transcervical Fibroid Ablation System 2.2
- K222734 — Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
- K223178 — SelectSite C304 Deflectable Catheter System, C315 Delivery System
- K212317 — Eclipse MINI Model 98900
- K220346 — Lotus Prophy Angle
- K220489 — Durex Patronus CloseFit, Durex Patronus Regular
- K220874 — Smooth Drive contra angle and straight handpieces
- K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module
- K222679 — Vericor Support Catheter
- K222732 — WaveForm A Interbody System
- K222741 — DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
- K222800 — Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
- K222873 — Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
- K222898 — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
- K222936 — Humeris® 135 Shoulder System
- K223127 — HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
- K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
- K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
- K212764 — Medwell Technology Ltd Syringes, various sizes
- K213108 — Humerus & Ulna System
- K220421 — BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
- K220833 — Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
- K221007 — cobas HCV
- K221086 — CryoRobot Select System
- K221162 — UniVy OsteoVy Cervical IBF System
- K221610 — Nextra CH Cannulated Hammertoe System
- K221659 — Luminopia One
- K221675 — United U2 femoral head, 22mm delta ceramic head
- K221822 — BENCHMARK BMX81 Access System
- K222049 — Yomi Robotic System
- K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
- K222453 — Self-adhesive Electrode
- K222639 — VHA Radiotherapy Bolus
- K222697 — Disposable Medical Face Mask (DF3-001)
- K223062 — World Total Knee System
- K223164 — Aquilo Sports CCT1500 System
- K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
- K220466 — ibiomedi Electronic Stethoscope ES-2020
- K221045 — Insulin Syringes without needle
- K221518 — NP Medical nCompass Extension Set with Stabilizing Base
- K221719 — ABTross ALIF Expandable Cage System
- K222107 — Black Diamond POCT Spinal System
- K222168 — Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
- K222377 — Led Mask Platinum Md
- K223110 — truSculpt iD
- K223355 — Tera Harz Clear
- K211816 — Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K220371 — Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
- K221184 — ORiGO System
- K222084 — OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
- K222395 — Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
- K223320 — Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K214090 — Back 3 COLOR
- K220539 — Klarity SRS Baseplate, Klarity Promise Baseplate
- K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
- K221478 — Dolphin Blue Imaging
- K222258 — Combined High Frequency X-ray Source
- K222508 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248
- K222550 — Current Health System
- K223270 — POSE Health Care Surgical Mask
- K213697 — ORiGO System
- K220890 — IO Needle Safety Sheath
- K220929 — Excelsior
- K221810 — LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
- K222085 — Standard Tapered Bougie, 38 Fr.
- K222318 — Fresenius Liberty Select Cycler
- K222717 — CL24N
- K222722 — CW60N
- K221064 — Nuheara IQbuds 2 PRO Hearing Aid
- K211060 — Disposable Surgical Gown Rk-3011C
- K212473 — Welch Allyn Connex Central Station
- K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
- K220305 — Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
- K220869 — Vapotherm Aerosol Adapter AAA-2
- K221406 — Vented Vial Transfer Pin
- K221435 — SUPERTILT PLUS (STP)
- K221521 — Disposable Safety Lancet
- K221667 — Non Sterile Powder Free Latex Examination Glove
- K222031 — Spinal Inner Fixation System
- K222191 — Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
- K222581 — Stela Automix System
- K222583 — Stela Capsule System
- K222653 — JOURNEY II UK and ENGAGE Cementless Partial Knee System
- K223020 — VS3-Iridium System (VS3-IR)
- K223064 — ALLY II Uterine Positioning System (UPS)
- K223070 — Remi Robotic Navigation System
Data sourced from openFDA. This site is unofficial and independent of the FDA.