510(k) Clearances — Page 199
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230796 — Sparrow Ascent | Spark Biomedical, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221024 — tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230346 — Voluson SWIFT; Voluson SWIFT+ | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231148 — ScleroSafe 150 mm, ScleroSafe 350 mm | Vvt Medical , Ltd. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223103 — BethaLoc® stem cementless HA | Implantcast GmbH Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231459 — HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230781 — Belle Sensilube | Rb Health (Us), LLC Tue Jun 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220072 — Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd. Sun Jun 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223920 — VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P | Vinno Technology (Suzhou) Co.,Ltd Sat Jun 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223917 — VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P | Vinno Technology (Suzhou) Co.,Ltd Sat Jun 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | NIKKISO CO., LTD. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220048 — Neoasis | Invictus Medical, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230910 — NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | Acculens, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223357 — EyeArt v2.2.0 | Eyenuk, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223556 — DeepCatch | Medical IP Co., Ltd. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222597 — BabySat 3 | Owlet Babycare, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231136 — Fitness Belt (Model: KLT-07) | Shenzhen Kelutongda Industrial Co., Ltd. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223646 — IB Lab LAMA | Ib Lab GmbH Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230421 — SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash | Siemens Medical Solutions USA, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230015 — OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver | Laurane Medical Sas Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231045 — Healgen URS Test Strips | Healgen Scientific,, LLC Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230538 — All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | Sonova AG Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223217 — Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222906 — Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 | Ningbo Maxcon Medical Technology Co., Ltd. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220907 — The iNAP One Sleep Therapy System | Somnics, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230894 — NuVasive Modulus ALIF System | Nu Vasive, Incorporated Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223890 — NAJA Gastrointestinal Catheter | Chess Medical, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230965 — Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222999 — Surgical Gown | Hubei Woozon Healthcare Co., Ltd. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220107 — Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231461 — Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221121 — Volumat Polyethylene I.V. Administration Set | Fresenius Kabi Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231199 — Solar Lumbar Interbody Fusion System | Degen Medical Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231110 — Manual Wheelchair (A006) | Ningbo Shenyu Medical Equipment Co.,Ltd Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220703 — F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230718 — UTC 3mL Medication Cartridge | Gilero, LLC Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223717 — Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231109 — Xerxes Hip Stem | Xerxes Arthopedix, LLC Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230386 — SpassageQ | Spass, Inc. Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231090 — Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223469 — WallFlex Biliary RX Stent System | Boston Scientific Corporation Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230762 — EDEN Spinal Fixation MIS System | Jmt Co., Ltd. Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222861 — EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Olympus Medical Systems Corporation Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230473 — IPL Hair Removal Device Models: MLY-T069 | Miley Technology (Hebei) Co., Ltd. Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223258 — TNI Clear-Guard 3 angled breathing filter (1545020) | Intersurgical , Ltd. Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231023 — ERBEJET® 2 System | Erbe Elektromedizin GmbH Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223715 — Celerity Incubator | STERIS Corporation Thu Jun 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230761 — TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231406 — ClearumTM HS | Bellco Srl Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230731 — Zavation ALIF System | Zavation Medical Products, LLC Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |