510(k) Clearances

174,759 clearances total

K241071 — NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K221275 — Qraycam PROAIOBIO Co., Ltd. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231502 — Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240646 — DreamClearSomnomed Technologies Inc., Doing Business AS Remware Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240142 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFujifilm Corporation Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242306 — SignalNED System (Model RE)Forest Devices, Inc. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242069 — Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242319 — Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc. Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240487 — EVOS Patella PlatesSmith & Nephew Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242251 — Litho 60; Litho 100; Litho 150Quanta System Spa Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241295 — SOMATOM On.siteSiemens Medical Solutions USA, Inc. Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233805 — K5Osstem Implant Co., Ltd. Chair Business Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241611 — ShapeIT (SI014135)Imds Operations B.V. Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241592 — Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. Sat Aug 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233872 — DaylightBig Health, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241148 — Salto Talaris Ankle PSI System3D Systems, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242275 — syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241602 — Kingcera Dental Zirconia BlankHunan Qinghao Puzhong Technology Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241823 — ToxiSeal™ Vial AdaptorEpic Medical Pte. , Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242249 — Conformity Stem Extension LineUnited Orthopedic Corporation Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240180 — Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242300 — MI View&GOSiemens Medical Solutions USA, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241847 — Imbio PHA (4.0.0)Imbio, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234027 — embecta Insulin Delivery SystemEmbecta Medical I, LLC Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241393 — ODI-TechOdi Medical AS Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233932 — Alinity i Toxo IgMAbbott Laboratories Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMVBoston Scientific Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241585 — uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241051 — Vave Wireless Ultrasound SystemVave Health, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241662 — Ultrasound Transducer CoverVitrolife Sweden AB Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241326 — Cadence Ankle PSI System3D Systems, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240003 — Velmeni for Dentists (V4D)Velmeni, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232441 — Unipro (K-UNIPRO-US)Tenscare, Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241518 — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)The Magstim Company Limited Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241957 — Talee, Talee PostOpInvent Medical USA, LLC Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241318 — Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231969 — BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)Dongguanshi Yiyingmei Technology Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241256 — JetBoots PRO PlusTherabody, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241386 — Heyman Packing Applicator Set (GM11004580)Varian Medical Systems, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242296 — VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)Ortho-Design (Pty), Ltd. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240105 — Navigator (FMNVG15); Navigator XL (FMNVX06)Forcemech International, LLC Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241881 — IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242346 — Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233826 — KosmosEchoNous, Inc. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous ChipsStryker Spine Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K220908 — Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241227 — RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241400 — SkinPen Precision Elite SystemCrown Aesthetics Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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