510(k) Clearances — Page 184
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231471 — Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231240 — MaxTack Motorized Fixation Device | Covidien Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232166 — PreXion3D Expedition | Prexion Corporation Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230310 — STAT Medical Device Lancing System | Stat Medical Devices Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231542 — Digital Blood Pressure Monitor WBP Series | Weony (Shenzhen) Technology Co., Ltd. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231687 — Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222823 — AeroDVx Arm System | Sun Scientific, Inc. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231800 — IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 | Shenzhen Qianyu Technology Co., Ltd. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231207 — CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221743 — Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes | Jiangsu Bonss Medical Technology Co., Ltd. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230649 — Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231996 — Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231999 — Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230644 — Signum opaque F | Kulzer, LLC Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231828 — Pounce Sheath | Surmodics,Inc. Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | Ttk Healthcare Limited Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223575 — Phoenix ICON, Phoenix ICON GO | Neolight, LLC Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232482 — MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230824 — IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Art Optical Contact Lens, Inc. Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230006 — esolution | S4 Medical Corp. Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230024 — HI-EMT MAGSHAPE | Beijing Sano Laser S&T Development Co.,Ltd Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230127 — Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231717 — IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 | Foshan Jindi Electric Appliance Co., Ltd. Wed Sep 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231819 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics Limited Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K200583 — Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility, LLC Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K201869 — Ki Power Tilt System | Ki Mobility, LLC Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230743 — ICHOR 14F Embolectomy System | Ichor Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232361 — Promaxo MRI System II | Promaxo, Inc. Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232691 — Polibond | Zirkonzahn Srl Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221869 — BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd. Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223684 — F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. Tue Sep 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223622 — FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230918 — MasterX 800 Series | Medicatech USA Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230805 — TriMed Clavicle Fixation System | TriMed, Inc. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213413 — Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223674 — eZSURE Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte. , Ltd. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213273 — Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics , Ltd. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232068 — HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232334 — DEKA SIMON | El.En S.P.A. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231270 — Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222988 — neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | Ht Medical D.B.A. Xenix Medical Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231884 — TRIOCLEAR System | Modern Dental Laboratory (Dg) Co., Ltd. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232314 — Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230317 — Elos Accurate Hybrid Base | Elos Medtech Pinol A/S Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232340 — Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | Arthrex, Inc. Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223901 — ApneaRX Pro | Apnea Sciences Coporation Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |