510(k) Clearances in 2023 — Page 48

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 48 of 67)
510(k) clearancesDetails
K230539 — ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. Apr 27, 2023
K230911 — Braun Skin i.expertCyden Limited Apr 27, 2023
K223212 — Precision DLGE Healthcare Apr 27, 2023
K221963 — Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited Apr 27, 2023
K222352 — Epildream HP 4000 MEDD.E.A Project S.R.1. Apr 27, 2023
K230272 — Renuvion® APR HandpieceApyx Medical Corporation Apr 27, 2023
K223398 — Gastric Alimetry SystemAlimetry , Ltd. Apr 27, 2023
K222694 — EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc. Apr 27, 2023
K230547 — PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil AdapterConmed Corporation Apr 27, 2023
K223210 — ClotTriever XL CatheterInari Medical, Inc. Apr 27, 2023
K223734 — ENT EMBrainlab AG Apr 27, 2023
K230844 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertConformis, Inc. Apr 27, 2023
K223892 — DentMix VPS Impression MaterialInnovative Product Brands, Inc. Apr 27, 2023
K222381 — PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH Apr 27, 2023
K223520 — UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc. Apr 27, 2023
K221983 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green ColorGuangdong Kingfa Sci. & Tech.Co., Ltd. Apr 27, 2023
K230845 — 32HL512D, 31HN713D, 32HQ713DLg Electronics.Inc Apr 27, 2023
K213078 — Myolift QTJohari Digital Healthcare Limited Apr 27, 2023
K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100Olympus Medical Systems Corporation Apr 26, 2023
K230829 — TENS7000 Rechargeable (Model:TENS7000 Rechargeable)Chongqing Rob Linka Science And Technology Co., Ltd. Apr 26, 2023
K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc. Apr 26, 2023
K230499 — ArtiSential Laparoscopic Instruments-ElectrodesLivsmed, Inc. Apr 26, 2023
K223932 — SafeAir combi (SFR-combi-US)Lina Medical Aps Apr 26, 2023
K222996 — Access PCTBeckman Coulter, Inc. Apr 26, 2023
K230552 — MR DWI/FLAIR Measurement V1.0Olea Medical Apr 26, 2023
K223868 — PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd. Apr 26, 2023
K222548 — Endo MotorShenzhen Perfect Medical Instruments Co., Ltd. Apr 26, 2023
K230218 — DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH Apr 25, 2023
K223139 — Wallaby 017 Micro CatheterWallaby Medical Apr 25, 2023
K220513 — NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation Apr 25, 2023
K230549 — IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BGShenzhen Xiazhifeng Electronic Co., Ltd. Apr 25, 2023
K230594 — Tigereye ST CTO-Crossing CatheterAvinger, Inc. Apr 25, 2023
K230204 — ALPHALOK Plating SystemVilex, LLC Apr 25, 2023
K230906 — Konicaminolta DI-X1Konica Minolta, Inc. Apr 25, 2023
K230223 — iCAC DeviceBunkerhill, Inc. Apr 25, 2023
K222676 — Ceevra Reveal 3Ceevra, Inc. Apr 25, 2023
K230056 — MiVu™ Esophageal Endo CapDiversatek Healthcare Apr 25, 2023
K230202 — TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. Apr 25, 2023
K230503 — Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific Apr 25, 2023
K230103 — Klockner AbutmentsSOADCO, S.L. Apr 24, 2023
K222690 — SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA Apr 24, 2023
K220261 — NEST-C Interbody SystemPaonan Biotech Co., Ltd. Apr 24, 2023
K220274 — Kisar Stratford SI Screw SystemAnjali Investments L.L.C Apr 24, 2023
K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,Ltd Apr 24, 2023
K222330 — The Heart SeatCasana Care, Inc. Apr 24, 2023
K223372 — Omnipod GO Insulin Delivery DeviceInsulet Corporation Apr 24, 2023
K230704 — RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp Apr 24, 2023
K223141 — STR8 Clear AlignerStr8 Oral Care Apr 24, 2023
K230136 — TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,Ltd Apr 24, 2023
K223069 — Modular Rotating Hinge Knee Systems and Compatible ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics Apr 21, 2023
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