510(k) Clearances — Page 160
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231820 — SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233520 — Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Anhui Powerguard Technology Co., Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220040 — Fibresolve | Imvaria, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233114 — LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) | Shenzhen Idea Light Limited Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233712 — PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233616 — Clevaligner Software (V1.0.0) | Clevaligner, Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232995 — Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe | Shenzhen Roundwhale Technology Co. , Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232250 — SurgiCount+ System | Stryker Instruments Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220066 — BrainSee | Darmiyan, Inc. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233664 — IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) | Shenzhen Ulike Smart Electronics Co., Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231088 — Copper Foam Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232285 — U-Lite PRO | Sonoscanner Sarl Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222929 — ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231633 — Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231774 — CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) | MacroLux Medical Technology Co., Ltd. Thu Jan 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233903 — Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. Wed Jan 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233364 — Axon Therapy | Neuralace Medical, Inc. Wed Jan 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233944 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics , Ltd. Wed Jan 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | Hangzhou Laihe Biotech Co., Ltd. Wed Jan 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232955 — Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. Wed Jan 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233902 — Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. Wed Jan 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233327 — 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy Tue Jan 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232312 — GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. Tue Jan 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232597 — LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. Tue Jan 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232710 — Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. Tue Jan 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231324 — DASI Dimensions (V1.0) | Dasi Simulations Mon Jan 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233035 — Electronic Muscle Stimulator (Model MP01) | Shenzhen Hengbosi Industrial Co., Ltd. Mon Jan 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233615 — Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 | Baisheng Medical Co., Ltd. Mon Jan 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232106 — Air Gap Fiber | Wontech Co., Ltd. Mon Jan 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232412 — LungQ v3.0.0 | Thirona BV Mon Jan 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232894 — HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) | Owens & Minor (O&M) Halyard, Inc. Mon Jan 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233444 — InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. Mon Jan 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231608 — Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. Sun Jan 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231068 — autoSCORE | Holberg Eeg AS Sun Jan 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232721 — Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Sun Jan 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231163 — HS Fiber Sutures | Riverpoint Medical Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | Anx Robotica Corporation Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233679 — IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG) | Shenzhen Ulike Smart Electronics Co., Ltd. Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231273 — ArcherQA (V1.0) | Wisdom Technologies., Inc. Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231917 — VEA Align | Eos Imaging Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233316 — DESS Dental Smart Solutions | Terrats Medical SL Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231263 — Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221766 — Solon | Lmg Lasers Comercio, Importacao E Exportacao Ltda Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232519 — ENDOCOLLECT Specimen Retrieval Bag | Ximedica Fri Jan 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232330 — Lancing System | Ningbo Medsun Medical Co., Ltd. Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231072 — Anthogyr FlexiBase® titanium bases for Axiom® BL | Anthogyr Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230996 — Pursuant Health Kiosk (G1.D5) | Pursuant Health Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221110 — LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing | Huizhou Foryou Medical Devices Co., Ltd. Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232808 — Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |