510(k) Clearances — Page 136
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240648 — Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240008 — Mobility Scooter (W3331) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Wed Jun 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233971 — Arthrex AlloSync PushLock Suture Anchor | Arthrex, Inc. Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232773 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240100 — SAM Model 9-10000 | Snap Diagnostics, LLC Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241258 — Ingenix Spinal System | Ingenium Spine Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240627 — LIAISON PLEX Yeast Blood Culture Assay | Luminex Corporation Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240463 — Slow Wave DS8 (SWDS802) | Slow Wave, Inc. Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240877 — Monteris Medical NeuroBlate System | Monteris Medical, Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240222 — Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) | Aesthetic Technology, Ltd. Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232820 — HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | Owens & Minor (O&M) Halyard, Inc. Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240505 — Eminent Spine SI Screw System | Eminent Spine, LLC Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234032 — Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line | Medline Industries, LP Tue Jun 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240617 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240251 — ANNE Chest | Sibel Health, Inc. Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241259 — Amplatz Goose Neck Snare Kit | Medtronic, Inc. Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240834 — EcoFit® short stem cementless cpTi | Implantcast GmbH Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240947 — TENSOR® Suture Button System | Globus Medical, Inc. Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240598 — Maestro System (REF100) | Moon Surgical Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233751 — Milieve (YPS-301BD) | Soterix Medical, Inc. Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231291 — Perforated Baskets | Richard Wolf Medical Instruments Corporation Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233587 — LOCATOR Angled Abutment (Various) | Zest Anchors, LLC Mon Jun 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240912 — Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240281 — Bone Suppression Software | Konica Minolta, Inc. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232080 — Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220062 — QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240913 — Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) | Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240394 — multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232107 — °M Warmer System | Mequ A/S Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232715 — Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233591 — Stylus | Degania Silicone , Ltd. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232333 — Anti-bacterial bandage | Jinhua Jingdi Medical Supplies Co., Ltd. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232738 — BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241226 — Fixtemp® C&B 4:1 | Dreve Denatmid GmbH Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232821 — S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232601 — BroncTru Transbronchial Access Tool | Broncus Medical, Inc. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233842 — iHealth COVID-19 Antigen Rapid Test | Ihealth Labs, Inc. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240969 — IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) | Shenzhen Semlamp Intelligent Technology Co., Ltd. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222196 — Deep TMS System | Brainsway , Ltd. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233295 — LFR-260 | Evolution Optiks Limited Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231151 — Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241055 — Electro Lube NXT | Steris Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240612 — CINA-VCF | Avicenna.Ai Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223427 — Mimics Enlight CMF | Materialise NV Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241218 — Tyber Medical Anatomical Plating System | Tyber Medical, LLC Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240254 — Blood Pressure Monitor (TMB-2296-BT) | Guangdong Transtek Medical Electronics Co., Ltd. Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | Vascular Solutions, LLC Fri May 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Biofire Diagnostics, LLC Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |