510(k) Clearances

174,759 clearances total

K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240591 — restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233699 — SubtleREFORMAT (1.x)Subtle Medical, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
DEN230052 — Eversense AP CGM SystemSenseonics, Incorporated Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240568 — DuraPro™ Oscillating SystemGlobus Medical, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240062 — ARVIS® ShoulderInsight Medical Systems, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240526 — POWEReam Xia/SerratoStryker Instruments Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240102 — Blood Pressure Monitor (TMB-2287-B)Guangdong Transtek Medical Electronics Co., Ltd. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233703 — Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240324 — EMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis) Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K221688 — ASTar BC G- Kit and ASTar InstrumentQ-Linea AB Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240091 — NB Mini Implant SystemArum Dentistry Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232302 — Pocket IIIQuantel Medical Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240566 — Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232261 — TME Temporary Myocardial ElectrodeOsypka AG Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232435 — Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233673 — uMR JupiterShanghai United Imaging Healthcare Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240872 — Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K220272 — cobas pulse blood glucose monitoring systemRoche Diagnostics Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232038 — BioStar Single Use Transbronchial Aspiration NeedleBroncus Medical, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240406 — Sonio DetectSonio Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233583 — FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232799 — syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233873 — XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240299 — Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232298 — DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231142 — Temporis, Irix PlusDws S.R.L. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233810 — Portrait VSMGe Medical Systems Information Technologies, Inc. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232357 — Copan Universal Transport Medium (UTM-RT) SystemCopan Italia Spa Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232331 — InVision Precision LVEF (LVEF)InVision Medical Technology Corporation Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232246 — 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless SutureM/s. Meril Endo Surgery Private Limited. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232405 — ENDOFIX EXOAktormed GmbH Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240535 — Digital ClarusScope System; Digital NeuroPEN SystemClarus Medical, LLC Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232805 — Kronos Electrocautery DeviceSingle Pass, Inc. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240846 — CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone CementCarboFix Orthopedics , Ltd. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234065 — CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232796 — LUOFUCON® Collagen Particles (Collagen Wound Dressing)Huizhou Foryou Medical Devices Co., Ltd. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240855 — Dental Cone-beam Computed TomographyYian Medical Technology (Haining) Co., Ltd. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234056 — canturio® se (Canturio Smart Extension)Canary Medical USA, LLC Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232181 — Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)Hebei JT Medical Co., Ltd. Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240623 — Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240208 — DESS Dental Smart SolutionsTerrats Medical SL Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233764 — SSS-NX (Serum Substitute Supplement-NX)Fujifilm Irvine Scientific Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240093 — IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd. Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240822 — Image Management V15Philips Medical Systems Technologies Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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