510(k) Clearances

174,759 clearances total

K233850 — Difiney Anti Snoring DeviceFissiontech, LLC Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232627 — HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240258 — Disposable Medical Face Mask (M643BE)Makrite Industries, Inc. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240046 — Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233924 — EMBOGUARD Balloon Guide CatheterNeuravi Limited Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234098 — Mobility Scooter (C4+)Yongkang Yile Vehicle Co., Ltd. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240085 — zLOCK Lumbar Facet Fixation SystemZygofix , Ltd. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K230233 — Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc. Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240484 — MSFX Mikron Cervical Anterior Plate SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240039 — Enteral Feeding SetsHangzhou Primecare Medical Co., Ltd. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233863 — TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-TriMed, Inc. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232238 — Goyo Mouthpiece SDimedikorea Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233186 — uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240032 — Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240057 — TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231646 — Carilex VT¿200-i NXCarilex Medical, Inc. Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232256 — Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233962 — ReBorn (1050nm)Lightfective , Ltd. Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240748 — nextaro® v, 20/20Sfm Medical Devices GmbH Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232202 — Aperio GT 450 DXLeica Biosystems Imaging, Inc. Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232133 — Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation) Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233886 — Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232208 — Sectra Digital Pathology Module (Version 3.3)Sectra AB Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K223113 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsMedentika GmbH Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240205 — Ez Catch Auto; Ez Catch YR; Ez Catch TRVeol Medical Technologies Pvt , Ltd. Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232926 — Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232904 — Access OstaseBeckman Coulter Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240884 — Glide (91000-GL-X)Infinite Biomedical Technologies, LLC Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240773 — VisAble.IOTechsomed Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233411 — Folysil Silicone CatheterColoplast Corp. Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232175 — XN Knee Prosthesis SystemBeijing Chunlizhengda Medical Instruments Co., Ltd. Sun Apr 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240703 — Fine Osteotomy™Bodycad Laboratories, Inc. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240686 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLC Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240418 — Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240238 — Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240419 — UltraThineer Zirconia Slurry (5Y-B)Boston Micro Fabrication Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240452 — Ceramic Femoral HeadMicroport Orthopedics, Inc. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240109 — Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K222766 — Disposable Extension SetShandong Ande Healthcare Apparatus Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232060 — TOSAMA Reusable ApplicatorTosama, D.O.O. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232489 — VenusXLinatech, LLC Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240571 — OASIS MRI SystemFujifilm Healthcare Corporation Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233034 — Mobility+ Enteral Feeding System OTCRockfield Medical Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232164 — Access NT-proBNPBeckman Coulter, Inc. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232200 — Disposable Injection NeedlesNingbo Xinwell Medical Technology Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream RxHangzhou Aichek Medical Technology Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232608 — Duo Hands-free Breast PumpMedela, LLC Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd. Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240720 — TiLink-P SI Joint Fusion SystemSurGenTec, LLC Thu Apr 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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