510(k) Clearances in 2022 — Page 30

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 30 of 65)
510(k) clearancesDetails
K221939 — Cemented Round Patella with JRNY PegsSmith & Nephew, Inc. Jul 26, 2022
K221502 — Parcus Synd-EZ SSParcus Medical, LLC Jul 26, 2022
K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG Jul 26, 2022
K221572 — VyPlate Anterior Cervical Plate SystemVy Spine, LLC Jul 26, 2022
K212407 — Gastric Lightguide (GLG)Naser Dib Gabinet Lekarksi Nasmed Jul 26, 2022
K221404 — Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)Conformis, Inc. Jul 26, 2022
DEN210032 — AccuMeasure SystemRQMIS, Inc. Jul 26, 2022
K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. Jul 26, 2022
K221409 — Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC Jul 25, 2022
K221460 — BioFire COVID-19 Test 2Biofire Defense, LLC Jul 25, 2022
K220439 — Viz SDHViz. Ai, Inc. Jul 25, 2022
K220606 — Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2Ambu A/S Jul 25, 2022
K220808 — Tigertriever 13 Revascularization DeviceRapid Medical Ltd. Jul 25, 2022
K221877 — Powder-Free Nitrile Examination Glove, Non-SterileGoodgloves Industries Sdn Bhd Jul 23, 2022
K221461 — 10HQ701G-BLg Electronics.Inc Jul 22, 2022
K221196 — Disposable Medical Face Mask (ear loop)Xiantao Topmed Nonwoven Protective Products Co., Ltd. Jul 22, 2022
K220486 — Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited Jul 22, 2022
K211891 — DM Converter - TiN coatedMedacta International S.A. Jul 22, 2022
K221234 — TargetCoolRecensmedical, Inc. Jul 22, 2022
K220940 — EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound And Primary Care Diagnostics Jul 22, 2022
K221394 — 14HQ701G-BLg Electronics.Inc Jul 22, 2022
K221525 — PreXion3D Explorer PROPrexion Corporation Jul 22, 2022
K211399 — Sterile Level 3 Surgical GownBarco Tekstil Sanayi VE Ticaret A.S. Jul 22, 2022
K220064 — Synergy Marble (Model: Opasm)Yrs Group, Inc. Jul 22, 2022
K220624 — AI4CMR v1.0Ai4Medimaging Medical Solutions S.A. Jul 22, 2022
K212975 — MedWandMedwand Solutions, Inc. Jul 22, 2022
K220216 — C-Stem AMT LE ProsthesisDepuy Ireland UC Jul 22, 2022
K220906 — SECURE-LOCKXiros, Ltd. Jul 22, 2022
K220882 — Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And Jul 22, 2022
K221535 — Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC Jul 22, 2022
K203680 — BioFire JI Control Panel M420Maine Molecular Quality Controls, Inc. Jul 22, 2022
K211346 — BLUE 400Carl Zeiss Meditec, AG Jul 22, 2022
K213922 — FX SPSPixee Medical Jul 22, 2022
K213813 — DuraFuse Clip and Applier SystemNeuramedica, Inc. Jul 22, 2022
K213881 — Celerity IncubatorSTERIS Corporation Jul 21, 2022
K211952 — BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl. Jul 21, 2022
K220671 — Manual WheelchairHebei Ruilangde Medical Equipment Technology Group Co., Ltd. Jul 21, 2022
K220976 — Life Scope PT BSM-1700 Series Bedside MonitorNihon Kohden Corporation Jul 21, 2022
K211543 — Wei Nasal Jet TubeWell Lead Medical Co., Ltd. Jul 21, 2022
K220184 — Pump Alignment SyringeJiangsu Caina Medical Co.,Ltd Jul 21, 2022
K213158 — Syringe with permanently attached needleBerpu Medical Technology Co., Ltd. Jul 21, 2022
K221823 — Cionic Neural Sleeve NS-100Cionic Jul 21, 2022
K213773 — Insufflation Retention DeviceBpendo, LLC Jul 21, 2022
K220039 — AutoSegAi Medic, Inc. Jul 20, 2022
K221363 — AF LaserShenB Co., Ltd. Jul 20, 2022
K213060 — AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. Jul 20, 2022
K214080 — PentaflushPentaferte Italia S.R.L. Jul 20, 2022
K221512 — Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd. Jul 20, 2022
K220679 — Pediatric Nailing Platform FemurOrthoPediatrics Corp. Jul 20, 2022
K212178 — Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd. Jul 20, 2022
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