510(k) Clearances — Page 182
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232121 — Power wheelchair (Model:BC-EA8000) | Ningbo Baichen Medical Devices Co., Ltd. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222610 — Elecsys Anti-Tg | Roche Diagnostics Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230332 — Ambu® aScope Colon; Ambu® aBox 2 | Ambu A/S Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223812 — Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232102 — ClearPoint Array System (Version 1.2) | ClearPoint Neuro, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | Medsource International, LLC Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231235 — LW UCLA Abutment | Ossvis Co., Ltd. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231336 — T2 Biothreat Panel | T2biosystems, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220972 — Access Thyroglobulin | Beckman Coulter, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231791 — PENTO Nd:YAG and Alexandrite laser system | Ilooda Co,., Ltd. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231242 — Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231827 — BTI Dental Implant System UnicCa® Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230974 — NIDO Pedicle Screw System | Kalitec Medical Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230066 — Carnation series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF) | Zhenjiang Assure Medical Equipment Co., Ltd. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220735 — Avologi Gel Primer (Model: Av25) | Premier North America, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232508 — Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223857 — i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232199 — Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE) | Zhenjiang Assure Medical Equipment Co., Ltd. Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232827 — LightForce Orthodontic System | Lightforce Orthodontics Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231079 — LW Retraction Cap | Ossvis Co., Ltd. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231484 — PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230987 — FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230237 — Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230959 — VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220034 — NEUROShield | In-Med Prognostics L3c Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230526 — TEA Device | Transtimulation Research, Inc. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231147 — Hammerdesis Interphalangeal Fusion System | Intelivation Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223869 — ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230108 — Straumann® BLC and TLC Implants | Institut Straumann AG Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230167 — BACK 4 | Swims America Corp Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230775 — SOFIA EX Intracranial Support Catheter | MicroVention, Inc. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231030 — Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230746 — Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232146 — Anovo Pedestal | Momentis Surgical , Ltd. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231576 — cNeuro cPET | Combinostics OY Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232189 — OrionXR | Hoth Intelligence, Inc. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231353 — AccuCTP Pro | ArteryFlow Technology Co., Ltd. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232462 — ThermPix Thermovisual Camera | Usa Therm, Inc. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232124 — IPL Hair Removal, Model: W-1095, W-1098 | Shenzhen Wochuan Electronic Co., Ltd. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232487 — Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223885 — HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232485 — AMSCO 600 Steam Sterilizer | Steris Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230609 — NG Delivery Catheter | Balt USA, LLC Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230021 — ensoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230735 — Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221640 — AlloMap Heart Molecular Expression Testing | Caredx, Inc. Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |