510(k) Clearances — Page 170
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230589 — Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | Alcon Laboratories, Inc. Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232521 — ExactechGPS® Total Ankle Application | Blue Ortho Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233200 — XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | GEMSS HEALTHCARE CO., LTD. Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231445 — LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231652 — D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230451 — Aptima® Chlamydia trachomatis Assay | Hologic, Inc. Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231694 — MASADA Modular Spinal Fixation System | Astura Medical Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233443 — Vital Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231738 — NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232139 — Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233302 — OSSIOfiber® Compression Staple | OSSIO , Ltd. Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232392 — CT Lung Ventilation Analysis Software (CT:V) | 4Dmedical Limited Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232945 — Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232533 — ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232753 — EXPD 4343D; EXPD 3643D | DRTECH Corporation Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230463 — NSite Scoliosis Assessment App | Nsite, Inc. Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231012 — CoolSeal Trinity | Bolder Surgical, LLC Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN200070 — Simple 2 Test | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231818 — METIC- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232973 — Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232841 — Axial3D Insight | Axial Medical Printing Limited Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223414 — Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231852 — BinkieRT | Papricalab Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232461 — Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | Kossan International Sdn Bhd Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233434 — Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | Prismatik Dentalcraft, Inc. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232494 — MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutions USA, Inc. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230856 — BrainSpec Core Software | Brainspec, Inc. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232656 — BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231097 — Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | Prismatik Dentalcraft, Inc. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231783 — VitroPRO | CIVCO Medical Instruments Co., Inc. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231521 — Broncho Videoscope System | Scivita Medical Technology Co., Ltd. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232050 — saremco print BRIDGETEC | Saremco Dental AG Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232845 — IPL Cooling Hair Removal Device | Shenzhen Siken 3D Technology Development Co., Ltd. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230878 — QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231554 — UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233468 — Iconix Anchor | Riverpoint Medical Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232488 — Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232241 — Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) | Betters(Suzhou) Medical Co., Ltd. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232257 — Clarius Bladder AI | Clarius Mobile Health Corp. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232509 — Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231937 — Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232240 — Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231118 — Cystoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232083 — BriefCase-Quantification | Aidoc Medical , Ltd. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230849 — ELLAVI UBT | Sinapi Biomedical (Pty) , Ltd. Mon Nov 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231564 — Skin and Wound Cleanser | Winner Medical Co., Ltd. Fri Nov 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |