510(k) Clearances in 2022 — Page 8

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 8 of 65)
510(k) clearancesDetails
K222009 — aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. Nov 22, 2022
K221499 — Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd. Nov 22, 2022
K222992 — iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair MaterialInnovative Bioceramix, Inc. Nov 22, 2022
K213427 — PRIMED Pediatric FacemaskPrimed Medical Products, Inc. Nov 22, 2022
K221624 — Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc. Nov 22, 2022
K222951 — SM-VSedecal., Sa. Nov 21, 2022
K222645 — Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts Nov 21, 2022
K222246 — Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. Nov 21, 2022
K220846 — CORE-SNAREIncore Co., Ltd. Nov 21, 2022
K221078 — Intravenous Needles for Single Use,Safety Intravenous Needles for Single UseSichuan Prius Biotechnology Co., Ltd. Nov 21, 2022
K222420 — Disposable Blood Pressure CuffWenzhou Xikang Medical Instruments Co., Ltd. Nov 21, 2022
K211358 — Implanter incl. AccessoriesGuilin Woodpecker Medical Instrument Co., Ltd. Nov 21, 2022
K222980 — Pentax Medical Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd. Nov 21, 2022
K222372 — Kowa SL-19Kowa Company , Ltd. Nov 21, 2022
K221811 — Vista BC SealerInter-Med, Inc. Nov 21, 2022
K221075 — Infusion Sets for Single UseSichuan Prius Biotechnology Co., Ltd. Nov 21, 2022
K221069 — Infusion Sets for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd. Nov 21, 2022
K212936 — Vision Monitor- MonCvONEMetrovision Nov 21, 2022
K222390 — Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower Nov 21, 2022
K223257 — Miro3D Wound MatrixReprise Biomedical Nov 21, 2022
K223032 — SIS System (Version 5.6.0)Surgical Information Sciences, Inc. Nov 21, 2022
K221268 — SR-1 Skin Treatment SystemAVAVA, Inc. Nov 21, 2022
K221165 — Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and FentanylSri Trang Gloves (Thailand) Public Company Limited Nov 20, 2022
K221282 — Empatica Health Monitoring PlatformEmpatica S.R.L. Nov 20, 2022
K222535 — OCS Lung Donor Flush SetTransMedics, Inc. Nov 18, 2022
K221580 — Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd. Nov 18, 2022
K222189 — SiOxD Wound MatrixSioxmed, LLC Nov 18, 2022
K223003 — Banded Face MaskHubei Medlink Healthcare Co., Ltd. Nov 18, 2022
K221330 — BriefCaseAidoc Medical , Ltd. Nov 18, 2022
K213018 — Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited Nov 18, 2022
K222903 — Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC Nov 18, 2022
K221369 — FBCC Night GuardFbcc, Inc. Nov 18, 2022
K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia Nov 18, 2022
K222701 — MANTA LaserSqualus Med , Ltd. Nov 18, 2022
K223246 — Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration Nov 18, 2022
K220351 — Polso WatchChronisense Medical, Ltd. Nov 18, 2022
K222816 — Opulent TiNbN Coated KneeMeril Healthcare Pvt. , Ltd. Nov 18, 2022
K222539 — Facet Blood LancetsFacet Technologies, LLC Nov 18, 2022
K222493 — CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. Nov 18, 2022
K220658 — COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH Nov 18, 2022
K222496 — Electromed SmartVest Airway Clearance SystemElectromed, Inc. Nov 18, 2022
K222455 — Calibrate LTX Interbody SystemAlphatec Spine, Inc. Nov 18, 2022
K222477 — Hair Growth DeviceDongguan Lescolton Medical Equipment Co., Ltd. Nov 18, 2022
K223124 — EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PGDRTECH Corporation Nov 18, 2022
K221581 — Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd. Nov 18, 2022
K223293 — CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. Nov 18, 2022
K212911 — Konig Mogen ClampMedline Industries, Inc. Nov 18, 2022
K222518 — FX ContraNakanishi, Inc. Nov 17, 2022
K221479 — Persona Personalized Knee SystemZimmer, Inc. Nov 17, 2022
K220820 — Parky AppH2O Bilisim Yazilim Nov 17, 2022
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