510(k) Clearances in 2022 — Page 58

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 58 of 65)
510(k) clearancesDetails
K210208 — Titan CondomsTitan Condoms, LLC Feb 17, 2022
K213647 — Durex Patronus WideRb Health (Us), LLC Feb 17, 2022
K213625 — Vinyl Examination GlovesDezhou Hengchang Medical Technology Co., Ltd. Feb 17, 2022
K214022 — Accu-Chek Softclix Blood Lancing SystemRoche Diabetes Care, Inc. Feb 17, 2022
K220277 — Digital Intraoral X-ray SensorShenzhen Xpectvision Technology Co., Ltd. Feb 17, 2022
K213107 — Powder Free Blue Nitrile Examination GlovesNovid Ppe Sdn. Bhd. Feb 17, 2022
K213689 — Voluson P6, Voluson P8GE Healthcare Feb 17, 2022
K213972 — Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiXGe Healthcare Information Technologies, Inc. Feb 17, 2022
K211212 — LoFric ElleDentsply Sirona Feb 17, 2022
K220150 — TENS & PMS (Model: SM9126)Hong Qiangxing (Shenzhen) Electronics Limited Feb 17, 2022
K213982 — Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresPacific Instruments Feb 17, 2022
K213710 — da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc. Feb 17, 2022
K220124 — YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd. Feb 17, 2022
K220137 — Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps Feb 17, 2022
K212977 — SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsCordis Corporation Feb 17, 2022
K211679 — Xtractor deviceXcardia Innovation , Ltd. Feb 17, 2022
K212824 — Bluezone Model RX-450 Air PurifierBluezone Products, Inc. Feb 17, 2022
K213186 — NovoFlow Reinforced Ureteral StentColoplast Corp. Feb 16, 2022
K220136 — Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. Feb 16, 2022
K220419 — Apapro DesensitizerSangi Co., Ltd. Feb 16, 2022
K212886 — Broncoflex Agile, Broncoflex Vortex, ScreeniAxess Vision Technology Feb 16, 2022
K220147 — Aspiron S ACP SystemU&I Corporation Feb 16, 2022
K214044 — 14HQ901G-BLg Electronics.Inc Feb 16, 2022
K212930 — LumiVy Lumbar IBF SystemVy Spine, LLC Feb 16, 2022
K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLBio Compression Systems, Inc. Feb 16, 2022
K210636 — MorpheusS4S UK , Ltd. Feb 15, 2022
K203234 — t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. Feb 15, 2022
K210229 — Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. Feb 15, 2022
K203793 — RithmID-SD Steerable Diagnostic Electrophysiology CatheterSynaptic Medical Corporation Feb 14, 2022
K213606 — EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. Feb 14, 2022
K211610 — Fogarty Occlusion CatheterEdwards Lifesciences, LLC Feb 14, 2022
K213622 — Cionic Neural Sleeve NS-100Cionic Feb 14, 2022
K212011 — Vinyl Powder Free Examination GloveTop Glove Vietnam Company Limited Feb 14, 2022
K203337 — PainTB, PainTJPtech Co., Ltd. Feb 11, 2022
K212180 — Wearable Breast Pump (Model S12)Shenzhen TPH Technology Co., Ltd. Feb 11, 2022
K213874 — MAVERICK External Fixation SystemSmith & Nephew, Inc. Feb 11, 2022
K211712 — 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate SystemOrthofix US, LLC Feb 11, 2022
K212570 — OsteoPlan SystemOsteomed, LLC Feb 11, 2022
K213328 — Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH Feb 11, 2022
K211400 — Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. Feb 11, 2022
K213617 — Surgical Face MaskMegasoft (China) Co., Ltd. Feb 11, 2022
K213462 — EzRay M18 (Model: VMX-P400)VATECH Co., Ltd. Feb 11, 2022
K211024 — Electric Breast PumpShantou Huihengqi Electronic Technology Co., Ltd. Feb 11, 2022
K213603 — SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited Feb 11, 2022
K213664 — B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc. Feb 11, 2022
K211248 — ArtUsTelemed Feb 11, 2022
K213487 — ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. Feb 11, 2022
K213890 — IMICRYL Impression MaterialsImicryl Dis Malzemeleri San. VE Tic. A.S. Feb 11, 2022
K212885 — Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC Feb 11, 2022
K212622 — Zyter RPMZyter, Inc. Feb 11, 2022
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