510(k) Clearances — Page 200

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 200 of 3,525)
ClearancesDetails
K221869 — BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. Sep 5, 2023
K223684 — F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd. Sep 5, 2023
K213413 — Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd. Sep 1, 2023
K230805 — TriMed Clavicle Fixation SystemTriMed, Inc. Sep 1, 2023
K213273 — Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd. Sep 1, 2023
K232657 — InnerView LCPerimetrics, Inc. Sep 1, 2023
K230918 — MasterX 800 SeriesMedicatech USA Sep 1, 2023
K223622 — FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. Sep 1, 2023
K231884 — TRIOCLEAR SystemModern Dental Laboratory (Dg) Co., Ltd. Sep 1, 2023
K223674 — eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte. , Ltd. Sep 1, 2023
K232334 — DEKA SIMONEl.En S.P.A. Sep 1, 2023
K231270 — Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc. Sep 1, 2023
K232314 — Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FUJIFILM Healthcare Americas Corporation Sep 1, 2023
K222988 — neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical Sep 1, 2023
K232068 — HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd. Sep 1, 2023
K230317 — Elos Accurate Hybrid BaseElos Medtech Pinol A/S Sep 1, 2023
K232340 — Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc. Sep 1, 2023
K223901 — ApneaRX ProApnea Sciences Coporation Sep 1, 2023
K231047 — UniSyn Molecular Imaging (6-3-1)Convergent Imaging Solutions Sep 1, 2023
K232014 — CONDUIT™ ATP InsertersEnztec Limited Sep 1, 2023
DEN230007 — LightStrike+ (MXSUV1-SL and MXSUV1-FT)Xenex Disinfection Services, Inc. Sep 1, 2023
K232021 — Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. Sep 1, 2023
K230623 — KITE Distal Fibula KitIntrauma S.P.A Sep 1, 2023
K221601 — MS-39C.S.O. S.R.L. Sep 1, 2023
K231710 — OW100SSoftwave/Trt, LLC Sep 1, 2023
K231626 — OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc. Aug 31, 2023
K213271 — MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical Aug 31, 2023
K222563 — BD Kiestra IdentifABecton, Dickinson And Company Aug 31, 2023
K232353 — Powder Free Nitrile Examination Gloves (Black)Shanxi Hongjin Plastic Technology Co., Ltd. Aug 31, 2023
K232287 — RAYSCAN a-Expert3DRay Co., Ltd. Aug 31, 2023
K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd. Aug 31, 2023
K223533 — Little Wave Arc; Little Wave FlipKi Mobility, LLC Aug 31, 2023
K231611 — HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies Aug 31, 2023
K231978 — BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50Vivachek Biotech (Hangzhou) Co., Ltd. Aug 31, 2023
K231323 — Ancora-SBAspero Medical, Inc. Aug 31, 2023
K230488 — EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH Aug 31, 2023
K221959 — Q21Neurofield, Inc. Aug 31, 2023
K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific Aug 31, 2023
K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus Scientific Aug 31, 2023
K223527 — Little Wave Clik, Rogue XP, Little Wave XP, SparkKi Mobility, LLC Aug 31, 2023
K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc. Aug 31, 2023
K223303 — Spinery™ RF Ablation SystemAxon Spine Medical System Aug 30, 2023
K232324 — StealthFix Intraosseous Fixation SystemMedartis, Inc. Aug 30, 2023
K231156 — Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc. Aug 30, 2023
K231246 — Ventrax™ Delivery System (VTR851)Merit Medical Systems, Inc. Aug 30, 2023
K230013 — Silk'n Titan AllwaysSilk'N Beauty , Ltd. Aug 30, 2023
K230355 — Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Aug 30, 2023
K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex Medical Aug 30, 2023
K231093 — AlphaVent Suture AnchorsStryker Endoscopy Aug 30, 2023
K232343 — AC3™ Series IABPArrow International, LLC Aug 30, 2023
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