510(k) Clearances — Page 138
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241396 — uCerv Flux-C 3D Porous Titanium Cervical Interbody | Ulrich Medical USA, Inc. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233108 — VinDr-Mammo | Vinbigdata Joint Stock Company Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233251 — NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232603 — CamAPS FX | Camdiab , Ltd. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233868 — dima Print Teeth & Temp | Kulzer, LLC Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation | Brainlab AG Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240294 — Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233120 — CWM-930S, FIXER DV9 | Chungwoo Co., Ltd. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232642 — AirKEE T900 | Healkee Medical Pte, Ltd. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232602 — 3DMatrix Surgical Mesh | Printbio, Inc. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233268 — Impress Angiographic Catheter | Merit Medical Systems, Inc. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241014 — Biomet Kirschner Wires (K-Wires) | Biomet, Inc. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241143 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233884 — INUMI Flex Needle | Galvanize Therapeutics, Inc. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240224 — Zenition 90 | Philips Medical Systems Nederlands B.V. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232655 — Bonvadis® | Stemcyte, Inc. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232740 — Paltop Short Implants | Paltop Advanced Dental Solutions, Ltd. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240456 — Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233099 — Gladiator | Rohrer Aesthetics, LLC Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241106 — Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) | Shenzhen Mlay Intelligent Technology Co., , Ltd. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233819 — Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240199 — IntraOp Alignment System | Alphatec Spine, Inc. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241126 — OviTex PRS | TELA Bio, Inc. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240433 — ProSeal Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232946 — Yumizen H2500 | HORIBA ABX SAS Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) | Centers for Disease Control and Prevention Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233442 — troCarWash System | Biotex, Inc. Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233543 — YSIO X.pree | Siemens Medical Solutions Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232759 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233336 — 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | Acula Technology Corp. Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240806 — Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | Tianjin Huahong Technology Co., Ltd. Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232677 — Reia pessary | Reia, LLC Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230068 — 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190 | 3M Company Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233341 — Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | Covidien, LLC Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240520 — Diode Laser Hair Removal System (SH-VD910) | Beijing Sea Heart International Science and Technologyco.Ltd Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233620 — MIM - Centiloid Scaling | Mim Software, Inc. Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240772 — Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) | Hunan Ceramaster Material Technology Co., Ltd. Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240511 — Dentis s-Clean SQ-SL Fixture | Dentis Co., Ltd. Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223399 — AViTA Pulse Oximeter | Avita Corporation Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241276 — Vector Pedicle Screw System | Innovasis, Inc. Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240474 — Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241252 — Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232702 — Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac Mon May 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232793 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |