510(k) Clearances — Page 147
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240442 — MagnetOs Putty | Kuros Biosciences B.V Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240288 — SF Push- in Anchor | Surgical Fusion Technologies GmbH Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231209 — Rejoyn | Otsuka America Pharmaceutical, Inc. Sat Mar 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233211 — AVIEW CAC | Coreline Soft Co., Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233068 — Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232031 — LUNA 3D | Lap GmbH Laser Applikationen Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233622 — AlignRT Plus | Vision Rt, Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation | Genesys Spine Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240310 — LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232018 — Citrated: K, KH, RTH, FFH | Haemonetics Corporation Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230665 — Dose IQ Safety Software | Baxter Healthcare Corporation Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211122 — Novum IQ Large Volume Pump | Baxter Healthcare Corporation Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240608 — MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232825 — Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240587 — SmoothSkin Pure Unplugged (SSB3) | Cyden Limited Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233609 — CORE 500 Digital Stethoscope | Eko Health, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240295 — InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240284 — Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) | Shenzhen Browiner Tech Co., Ltd. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233909 — Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister | Argon Medical Devices, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B) | Medtronic, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232013 — Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) | Goodman Co., Ltd. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240171 — ProSeal Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233657 — NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233719 — FDR Visionary Suite | Shimadzu Corporation Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233409 — Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232047 — VIVACE | Unimom.Co Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233669 — OEC 3D | Ge Oec Medical Systems, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240693 — LINQ II Insertable Cardiac Monitor (ICM) | Medtronic, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232049 — IS-III active Short Implant | Neobiotech Co., Ltd. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233604 — BTL-785S | BTL Industries, Inc. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240567 — CustomizedBone Service | Fin-Ceramica Faenza S.P.A. Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223360 — LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | Hyundae Meditech Co., Ltd. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222613 — ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234150 — Lucent® XP | Spinal Elements Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240045 — QStat Cartridge | Hemosonics, LLC Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231425 — Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | Wuxi Jiajian Medical Instrument Co., Ltd. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232891 — CARPL (CARPL) | Carpl Ai, Inc. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233951 — CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233989 — CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics , Ltd. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234097 — Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Ever Growth (Vietnam) Corporation Limited Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234143 — i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210049 — Medline ART Skin Harvesting System | Medline Industries, Inc. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232253 — Modius Stress | Neurovalens Limited Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233539 — MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233201 — MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | Penumbra, Inc. Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240594 — Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |