510(k) Clearances in 2022 — Page 12

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 12 of 65)
510(k) clearancesDetails
K222395 — Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoEllex Medical Pty, Ltd. Nov 2, 2022
K211816 — Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateBrightway Holdings Sdn. Bhd. Nov 2, 2022
K221184 — ORiGO SystemBien-Air Surgery SA Nov 2, 2022
K220539 — Klarity SRS Baseplate, Klarity Promise BaseplateKlarity Medical & Equipment (GZ) Co., Ltd. Nov 1, 2022
K214090 — Back 3 COLORSwims America Corp Nov 1, 2022
K223270 — POSE™ Health Care Surgical MaskAmerica'S Supply Chains Nov 1, 2022
K222258 — Combined High Frequency X-ray SourceSuzhou Powersite Electric Co., Ltd. Nov 1, 2022
K222508 — 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 12483M Company Nov 1, 2022
K221478 — Dolphin Blue ImagingPatterson Dental Supply, Inc. Nov 1, 2022
K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable NeedleJiangsu Kangbao Medical Equipment Co., Ltd. Nov 1, 2022
K222550 — Current Health SystemCurrent Health , Ltd. Nov 1, 2022
K222717 — CL24NWide Corporation Oct 31, 2022
K221810 — LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceBonraybio Co., Ltd. Oct 31, 2022
K213697 — ORiGO SystemBien-Air Surgery SA Oct 31, 2022
K222318 — Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC Oct 31, 2022
K222722 — CW60NWide Corporation Oct 31, 2022
K222085 — Standard Tapered Bougie, 38 Fr.Standard Bariatrics, Inc. Oct 31, 2022
K220929 — ExcelsiorMerit Cro, Inc. Oct 31, 2022
K220890 — IO Needle Safety SheathActuated Medical, Inc. Oct 31, 2022
K221064 — Nuheara IQbuds 2 PRO Hearing AidNuheara Limited Oct 30, 2022
K223064 — ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc. Oct 28, 2022
K220869 — Vapotherm Aerosol Adapter AAA-2Vapotherm, Inc. Oct 28, 2022
K223070 — Remi Robotic Navigation SystemFusion Robotics, LLC Oct 28, 2022
K222581 — Stela Automix SystemSdi Limited Oct 28, 2022
K221435 — SUPERTILT PLUS (STP)Power Plus Mobility Oct 28, 2022
K212473 — Welch Allyn Connex Central StationWelch Allyn, Inc. Oct 28, 2022
K223098 — Bakri Essential Postpartum BalloonCook Incorporated Oct 28, 2022
K221521 — Disposable Safety LancetSteriLance Medical (Suzhou), Inc. Oct 28, 2022
K222653 — JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc. Oct 28, 2022
K222191 — Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40Supersonic Imagine Oct 28, 2022
K223020 — VS3-Iridium System (VS3-IR)Visionsense, Ltd. Oct 28, 2022
K221667 — Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd. Oct 28, 2022
K211060 — Disposable Surgical Gown Rk-3011CXiantao Rhycom Non-Woven Products Co., Ltd. Oct 28, 2022
K222583 — Stela Capsule SystemSdi Limited Oct 28, 2022
K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)Kontour(Xi’An) Medical Technology Co., Ltd. Oct 28, 2022
K220305 — Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon Oct 28, 2022
K222031 — Spinal Inner Fixation SystemChangzhou Geasure Medical Apparatus And Instruments Co., Ltd. Oct 28, 2022
K223079 — StageSpintech, Inc. Oct 28, 2022
K222678 — Mobility+ Enteral Feeding SystemRockfield Medical Oct 27, 2022
K222514 — S.I.N. Instrument KitsS.I.N. – Sistema DE Implante Nacional S.A. Oct 27, 2022
K212745 — ORAcollect®•DxDNA Genotek, Inc. Oct 27, 2022
K222601 — FilmArray Pneumonia Panel plusBiofire Diagnostics, LLC Oct 27, 2022
K222952 — 2008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC Oct 27, 2022
K221420 — AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols Company Oct 27, 2022
K222348 — JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd. Oct 27, 2022
K222966 — Cirq Arm System (2.0);Alignment System SpineBrainlab AG Oct 27, 2022
K221322 — CUSTMBITE Snoring SystemDental Choice Holdings, LLC Oct 27, 2022
K222288 — DESS Dental Smart SolutionsTerrats Medical SL Oct 27, 2022
K222231 — S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. Oct 27, 2022
K220880 — Arthrex BioSutureArthrex, Inc. Oct 27, 2022
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