510(k) Clearances in 2022 — Page 2

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 2 of 65)
510(k) clearancesDetails
DEN220017 — BioXmarkNanovi A/S Dec 23, 2022
K221048 — Episealer Patellofemoral SystemEpisurf Medical, Inc. Dec 23, 2022
K211485 — STA- NeoPTimalDiagnostica Stago S.A.S Dec 23, 2022
K222164 — Visant Medical Canalicular PlugVisant Medical, Inc. Dec 23, 2022
K223071 — Xenoview VDPPolarean, Inc. Dec 23, 2022
K222924 — Leg Massager RF-ALM070Shenzhen Ruiyi Business Technology Co., Ltd. Dec 23, 2022
K223105 — Tesera-K SC SystemKyocera Medical Technologies, Inc. Dec 22, 2022
K222216 — TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC Dec 22, 2022
K223273 — ASTRA Spine SystemSpinecraft, LLC Dec 22, 2022
K223311 — Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd. Dec 22, 2022
K222262 — SunriseSunrise SA Dec 22, 2022
K221396 — Arthrex FiberTak Suture AnchorArthrex, Inc. Dec 22, 2022
K222894 — Invisalign System, Pre-Formed Attachment SystemAlign Technology, Inc. Dec 22, 2022
K221428 — PerioStom Dental DressingForward Science, LLC Dec 22, 2022
K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc. Dec 22, 2022
K222949 — Air Compression Leg Massager (Model: LY-670D)Zhejiang Luyao Electronics Technology Co., Ltd. Dec 22, 2022
K211058 — Lp(a) UltraSENTINEL CH. SpA Dec 22, 2022
K223649 — VERTICALE® Navigation InstrumentsSilony Medical GmbH Dec 22, 2022
K221377 — SteriKing LT-Blueline Pouches with TyvekWipak OY Dec 22, 2022
K222774 — iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. Dec 22, 2022
K223547 — Biograph Vision Quadra PET/CT SystemSiemens Medical Solutions USA, Inc. Dec 22, 2022
K222806 — Kodiak C Spinal Implant SystemMet One Technologies, LLC Dec 22, 2022
K223142 — Coltolux Comfort LED Curing LightDent4You AG Dec 22, 2022
K221902 — LimFlow VectorLimFlow, Inc. Dec 21, 2022
K221054 — CORE-INJECTORIncore Co., Ltd. Dec 21, 2022
K221826 — BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)Becton, Dickinson And Company Dec 21, 2022
K213235 — PENTAX Medical ONE Pulmo Single Use Video Bronchoscope SystemPentax Of America, Inc. Dec 21, 2022
K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc. Dec 21, 2022
K202965 — CURA-TempMgnewton , Ltd. Dec 21, 2022
K220012 — BresoDX1Bresotec, Inc. Dec 21, 2022
K213875 — DRI TM Tricyclics Serum Tox AssayMicrogenics Corporation Dec 21, 2022
K223482 — reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. Dec 21, 2022
K221698 — Eargo 5 , Eargo 6Eargo, Inc. Dec 21, 2022
K222637 — TriMed Wrist Fixation System 3TriMed, Inc. Dec 21, 2022
K213893 — Comfort Gown, Safewear GownXuchang Zhengde Environstar Medical Products Co., Ltd. Dec 21, 2022
K223244 — Pristine Arthroscopic Visualization SystemPristine Surgical Dec 21, 2022
K222351 — inspired™ VHB20 Heated HumidifierVincent Healthcare Products Limited Dec 21, 2022
K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. Dec 21, 2022
K221720 — Extra Silver Gelling Fiber DressingWinner Medical Co., Ltd. Dec 21, 2022
K222234 — GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp. Dec 21, 2022
K221911 — VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXPVinno Technology (Suzhou) Co.,Ltd Dec 21, 2022
K213564 — BiWaze Clear SystemAbmrc, LLC Dec 21, 2022
K220286 — ELECTROCYN somaV3Bio Sdn. Bhd Dec 21, 2022
K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. Dec 21, 2022
K221221 — Advanced Intramedullary Nail SystemDouble Medical Technology, Inc. Dec 21, 2022
K222864 — 8MP Color LCD Monitor CL-R813Jvckenwood Corporation Dec 21, 2022
K222586 — Mural Clinical ViewerGe Medical Systems Information Technologies, Inc. Dec 21, 2022
K213677 — Bonafix 2 PlusZentek Medical, LLC Dec 20, 2022
K220991 — IntelliSep testCytovale, Inc. Dec 20, 2022
K221603 — Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™Cardinal Health, LLC Dec 20, 2022
← Previous Page 2 of 65 Next →