510(k) Clearances — Page 90
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243503 — VIA360 Surgical System | New World Medical, Inc. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241527 — Pastelle Pro | Wontech Co., Ltd. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243212 — DESS Dental Smart Solutions | Terrats Medical SL Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241643 — WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243696 — AVIEW CAC | Coreline Soft Co., Ltd. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241958 — WARD-CSS (v1.2.x) | Ward 24/7 Aps Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243081 — Green X 21 (PHT-90CHO) | VATECH Co., Ltd. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242198 — ICS Dizcovery (1091) | Natus Medical Denmark Aps Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250248 — BriefCase-Triage | Aidoc Medical , Ltd. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241573 — Alinity m Resp-4-Plex | Abbott Molecular, Inc. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242593 — CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242776 — LimFlow V-Ceiver | LimFlow, Inc. Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243912 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242104 — Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241597 — Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243319 — Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243778 — Body Temperature Software (BTS) | Fitbit, LLC Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241832 — Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | Boston Aesthetics, Inc. Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243546 — AH Plus Endodontic Sealer | Dentsply Sirona, Inc. Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243396 — Aptima SARS-CoV-2 Assay | Hologic, Inc. Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241410 — EDEN ControlCath | Jmt Co., Ltd. Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242317 — Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241425 — AspenView | Aspen Imaging Healthcare, Inc. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243961 — Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243907 — Affixus Tibial Nailing System - 4mm screws | Zimmer, Inc. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243702 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243250 — SubtleHD (1.x) | Subtle Medical, Inc. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242006 — SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243962 — Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242666 — Fecobionics Anorectal System | Gi Bionics, LLC Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241418 — OptoMonitor 3 | Opsens, Inc. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243523 — NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241897 — MOR | Morari, Inc. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243155 — Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) | Dongguan Zsr Biomedical Technology Company Limited Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241634 — Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241462 — LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243518 — BinaxNOW COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243188 — CYLOX® ST | Signus Medizintechnik GmbH Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243317 — NUVENTUS NV.C Surgical Cassette and Tray | Infinitum Eta, Ltd. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243628 — Vivid T9/Vivid T8 | GE Medical Systems Ultrasound and Primary Care Diagnostics Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Roche Molecular Systems, Inc. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241817 — InSet Total Shoulder System | Shoulder Innovations, Inc. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250200 — InbellaBody System | Inbella Medical, Inc. Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243620 — Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243063 — Myolight Microcurrent Handpiece | Raja Trading Company, Inc. Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |