510(k) Clearances in 2023 — Page 57

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 57 of 67)
510(k) clearancesDetails
K223642 — LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. Mar 9, 2023
K221301 — DESS Dental Smart SolutionsTerrats Medical SL Mar 9, 2023
K230363 — CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC Mar 9, 2023
K221706 — AccuContourManteia Technologies Co., Ltd. Mar 9, 2023
K222355 — PathKeeper SystemPathkeeper Surgical , Ltd. Mar 8, 2023
K230321 — Persona™ Personalized Knee SystemZimmer, Inc. Mar 8, 2023
K222136 — Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd. Mar 8, 2023
K223742 — Dental Ceramic BlocksAidite (Qinhuangdao) Technology Co., Ltd. Mar 8, 2023
K222098 — ManaSport+Manamed, Inc. Mar 8, 2023
K221209 — PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsPadm Medical, Inc. Mar 8, 2023
K222007 — Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. Mar 8, 2023
K220966 — SINEFIXBAAT Medical Products B.V. Mar 8, 2023
K220613 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated Mar 8, 2023
DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation Mar 8, 2023
K230076 — Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc. Mar 8, 2023
K220101 — Pulse OximeterBeijing Choice Electronic Technology Co., Ltd. Mar 8, 2023
K213906 — extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd. Mar 8, 2023
K223688 — CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl Mar 8, 2023
K223681 — Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd. Mar 8, 2023
K220407 — Visby Medical Sexual Health TestVisby Medical Mar 7, 2023
K230301 — Athena III Cervical Plate SystemMedyssey USA, Inc. Mar 7, 2023
K221883 — Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. Mar 7, 2023
K222465 — Tyber Medical Anatomical Plating SystemTyber Medical, LLC Mar 7, 2023
K220549 — MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014Hans Biomed Corporation Mar 7, 2023
K223024 — MedCAD AccuPlan SystemMedcad Mar 7, 2023
K223401 — Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. Mar 7, 2023
K213892 — Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineRb Health (Us), LLC Mar 7, 2023
K230331 — Protrieve SheathInari Medical, Inc. Mar 7, 2023
K222897 — Enlight 2100Timpel S.A. Mar 7, 2023
K223726 — Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems Corporation Mar 7, 2023
K223930 — A1417MCW/A1717MCW/F1417MCWH&Abyz Co., Ltd. Mar 6, 2023
K223653 — BD Vaginal PanelBecton, Dickinson And Company Mar 6, 2023
K222672 — Disposable Insulin SyringeHantech Medical Device Co., Ltd. Mar 6, 2023
K223232 — Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd. Mar 6, 2023
DEN210033 — Lenire Tinnitus Treatment DeviceNeuromod Devices Limited Mar 6, 2023
K230383 — Savvy Surgical Mask - Level 3Alg Health, LLC Mar 6, 2023
K221621 — Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics Mar 6, 2023
K222445 — LC ChromeFlowS&C Polymer Silicon- Und Composite Spezialitaten GmbH Mar 6, 2023
K222457 — Provata Implant SystemSouthern Implants (Pty), Ltd. Mar 6, 2023
K212161 — Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation Mar 6, 2023
K230315 — Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerMaterialise NV Mar 6, 2023
K221158 — Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd. Mar 6, 2023
K223452 — Nitronox Scavenger PlusParker Hannifin Corporation Mar 5, 2023
K230060 — Light Based Hair Removal Device GP592Shenzhen Gsd Tech Co., Ltd. Mar 3, 2023
K222379 — Alinity m STI AssayAbbott Molecular, Inc. Mar 3, 2023
K230294 — CoverScan (CoverScan v1.1)Perspectum Mar 3, 2023
K223776 — PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus And Instruments Co., Ltd. Mar 3, 2023
K221587 — DHX-70H, XTG-70HDigimed Co., Ltd. Mar 3, 2023
K222394 — Electronic SphygmomanometersQingdao Yasee Medical Device Co., Ltd. Mar 3, 2023
K222819 — Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation Mar 3, 2023
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