510(k) Clearances — Page 157
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240025 — Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232678 — Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210035 — Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Hologic, Inc. Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231396 — CEPHX- Cephalometric Analysis Software | Orca Dental AI , Ltd. Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K214115 — MightySat -OTC | Masimo Corporation Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240004 — CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer | Circa Scientific, Inc. Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | Hygea Medical Technology Co., Ltd. Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232986 — VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232432 — E3D-A Interbody System | Evolution Spine Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234140 — VIVA combo RF System (VIVA combo RF System) | Starmed Co., Ltd. Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231343 — Redemption Duo Hindfoot Nail System | Vilex, LLC Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231910 — DermRays Revive | Wuhan Lotuxs Technology Co., Ltd. Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240020 — Ziehm Vision FD | Ziehm Imaging GmbH Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232942 — G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media | Gimbo Medical Technology Shenzhen Co., Ltd. Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230794 — Rebuilder Nerve Guidance Conduit | Celestray Biotech Company, LLC., Mon Jan 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233394 — Gem Flow Now (GEM2770-FN) | Synovis Micro Companies Alliance Sun Jan 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233224 — Epilaser Pro | Epilady 2000, LLC Sat Jan 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232864 — EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | Nantong Egens Biotechnology Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233485 — M-Wave | Zynex Medical, Inc. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231785 — Perifit Pump | X6 Innovations Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234145 — ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232450 — Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233598 — Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Anhui Intco Medical Products Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231282 — LifeOutcomes C-Quest Blood Culture Sampling Device | Lifeoutcomes, LLC Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233299 — ExactechGPS® System | Blue Ortho Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231715 — MONDRIAN Anterior Lumbar Plate System | Ctl Medical Corporation Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234118 — CentriMag Acute Circulatory Support System | ABBOTT MEDICAL Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231329 — Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231303 — Arm-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232182 — One-Fil | Mediclus Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233508 — iFuse Bedrock Granite® Implant System | SI-BONE, Inc. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234109 — Ziehm Solo FD | Ziehm Imaging GmbH Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233735 — ADIRA Lateral Plate System | Globus Medical, Inc. Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233893 — AlphaVent Knotless SP PEEK Anchor | Stryker Endoscopy Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233425 — FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | Sutter Medizintechnik GmbH Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | CooperVision, Inc. Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233714 — BreView | GE Medical Systems SCS Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232665 — GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | Convatec Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232417 — MR Q; MR Q SUPINE; MR Q SLT | Meridian AG Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232912 — Facet Aurora Reusable Lancet Base | Facet Technologies, LLC Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | The Binding Site, Ltd. Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233195 — Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231607 — Axial3D Cloud Segmentation Service | Axial Medical Printing Limited Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233208 — NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | Nobel Biocare AB Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230836 — SchurSign Tissue Marker | Surgmark GmbH Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232676 — Dental Porcelain Powder | Chengdu Besmile Medical Technology Co., Ltd. Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231305 — Endoform Dental Membrane | Aroa Biosurgery , Ltd. Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232917 — Chemo Mouthpiece | Chemo Mouthpiece, LLC Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231187 — Nano-Check COVID-19 Antigen Test | Nano-Ditech Corporation Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |