510(k) Clearances — Page 174
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231595 — Electric Breast Pump | Shenzhen Changkun Technology Co., Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Qura S.R.L Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233223 — OGmend® Implant Enhancement System | Woven Orthopedic Technologies Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230662 — Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Zhonghong Pulin Medical Products Co., Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231737 — ANAX 5.5 Spinal System | Innosys Co., Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231685 — TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233101 — Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230500 — Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) | Jiangsu Maxf Electric Appliance Co., Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231550 — Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233417 — AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. Thu Oct 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231327 — POWERSEAL Sealer and Divider | Gyrus Acmi, Inc. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233093 — Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corporation Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233113 — ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221315 — UNIdental Symphony Implant System | Unidental Co., Ltd. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233147 — PiXel8-RF | Rohrer Aesthetics Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231069 — PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230284 — Penumbra LP Coil System | Penumbra, Inc. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222997 — VVR Generator system | Starmed Co., Ltd. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230842 — SignalHF (IM008) | Implicity, Inc. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233210 — sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230511 — K3900 Ultrasound Imaging System | Maui Imaging Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232235 — Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | The Magstim Company , Ltd. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232436 — Rapid SDH | Ischemaview, Inc. Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221615 — Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231995 — AcuityUDR | Radmedix, LLC Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232356 — Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232683 — Knotilus+ PEEK Knotless Anchor | Stryker Endoscopy Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232570 — Steerant Super Stiff Guidewire | Medtronic Vascular Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter | Vein 360, LLC Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230472 — Sonopuls 190 | Enraf-Nonius, B.V. Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233348 — 16 Breast Coil | Philips Medical System Nederlands B.V. Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233185 — MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System | C2dx, Inc. Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230919 — Acumen IQ finger cuff | Edwards Lifesciences, LLC Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231509 — Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232223 — PlaDuo System | ShenB Co., Ltd. Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232211 — REUNION Sacroiliac Joint Fusion System | Astura Medical Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232086 — spineEOS | Eos Imaging Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232051 — VISULAS green | Carl Zeiss Meditec Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232586 — Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System | K&J Consulting Corp. Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232638 — FilteredFlo Warming Blankets | Iob Medical, Inc. Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231732 — CleanSeal Advanced Bipolar Vessel Sealer Maryland | Conmed Corporation Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | bioMerieux, Inc. Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232205 — Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set | Vesco Medical, LLC Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230281 — PICOCLAMP | Kono Seisakusho Co., Ltd. Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230893 — Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232305 — AI-Rad Companion Brain MR | Siemens Medical Solutions U.S.A. Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232143 — Applanation Tonometer HT-5000 | Huvitz Co., Ltd. Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233258 — Shadow Knotless All-Suture Anchors | Responsive Arthroscopy, LLC Mon Oct 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |