510(k) Clearances — Page 196
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K222220 — SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230968 — VYBE RF Electrosurgical System | ShenB Co., Ltd. Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230173 — Servo-air Lite Ventilator System | Maquet Critical Care AB Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230510 — MyEllevate | Cynosure, LLC Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223747 — Whitsundays Mask System | Resmed Pty Ltd (Registration Number: 3004604967) Thu Jul 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221058 — LungTrainer (MD2 & MD3) | Lung Trainers, LLC Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231358 — Universal Seal (5-12 mm) | Intuitive Surgical, Inc. Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222015 — Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc. Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220980 — Tissue Approximation System (TAS) | Tas Medical, Inc. Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231279 — Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230864 — VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | bioMerieux, Inc. Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230001 — Electric Scooter (Model: M2020) | Guangdong Prestige Technology Co., Ltd. Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231641 — Rotium Bioresorbable Wick | Nanofiber Solutions, LLC Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231740 — MemorialTM Gloves | Us Glove Supply Tue Jul 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230720 — LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230487 — Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co., Ltd. Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230025 — IVYLASER Handhold Hair Removal Machine | Ivylaser (Beijing) Technology Co.,Ltd Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | Cardinalhealth Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222745 — Axial3D Insight | Axial Medical Printing Limited Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231280 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | CarboFix Orthopedics , Ltd. Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221664 — CLEARinse CTS Specimen Collection and Transport System | Aardvark Medical, Inc. Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231653 — BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | Thrombolex, Inc. Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230901 — Premier HpSA Flex (619096) | Meridian Bioscience, Inc. Mon Jul 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230725 — NB Implant System | Arum Dentistry Co., Ltd. Sat Jul 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230944 — MeMed BV | MeMed Diagnostics, Ltd. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230935 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231588 — ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231596 — IOB Temperature Management System | Iob Medical, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223854 — Unistik® ShieldLock, Unistik VacuFlip | Owen Mumford, Ltd. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231252 — Ventana L Spinal System | Spinal Elements, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | Medtronic Vascular Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222466 — AirTom | Bilab Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230469 — Compact Wearable Pump | Lansinoh Laboratories Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230933 — REMI Remote EEG Monitoring System | Epitel, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231267 — ClearTip | Finemedix Co., Ltd. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221294 — preCARDIA Occlusion System | Abiomed, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231689 — iFuse TORQ® Implant System | SI-BONE, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231585 — Vantage PSI System | 3D Systems, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212409 — Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231264 — Easy On Universal Glaze & Stain | Doctus Global Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213253 — Pixyl.Neuro | Pixyl SA Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223135 — AblatePal Radiofrequency Ablation System | Compal Electronics, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230917 — FebriDx Bacterial / Non-bacterial Point of Care Assay | Lumos Diagnostics, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230456 — SGM Femoral Nail System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223374 — Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230052 — Inogen Rove 6 | Inogen, Inc. Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |