510(k) Clearances — Page 186
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231407 — StarFin | Premium Medical Technology, LLC Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230765 — Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. Tue Aug 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) | Versant Medical Physics and Radiation Safety Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232387 — Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223639 — VisAble.IO | Techsomed Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231676 — CALLISTO eye | Carl Zeiss Meditec, AG Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231422 — Precision GI | Limaca Medical, Ltd. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231537 — SofWave System | Sofwave Medical, Ltd. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230159 — SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231623 — Distal Elbow Plating System | Skeletal Dynamics, Inc. Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231435 — KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Kimberly-Clark Corporation Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222525 — Alveoair Digital Spirometer | Roundworks Technologies Private Limited Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231183 — Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223180 — AIRAscore | Airamed GmbH Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222786 — 072 Aspiration System | Q'Apel Medical, Inc. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222972 — BioProtect Balloon Implant System | Bioprotect, Ltd. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes | Becton, Dickinson and Company Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230094 — Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors | Responsive Arthroscopy, LLC Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231872 — Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) | Kirwan Surgical Products, LLC Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230364 — VitalFlow Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231994 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL | Thermo Fisher Scientific Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230928 — Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223898 — VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230566 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231903 — Montage-QS Settable, Resorbable Bone Putty | Orthocon, Inc. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223727 — Lavieen | Wontech Co., Ltd. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230409 — Wrist Type Blood Pressure Monitor (W05,W1101L) | Shenzhen Jamr Technology Co., Ltd. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230014 — MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | Tonica Elektronik A/S Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231255 — NovoFine® Plus | Novo Nordisk, Inc. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223600 — Sterilization Wrap | Wuhan Zonsen Medical Products Co., Ltd. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223807 — Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232214 — OMNI Surgical System | Sight Sciences, Inc. Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230165 — Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) | Coloplast Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231944 — CATAMARAN SI Joint Fusion System | Tenon Medical, Inc. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222103 — Nitrile Patient Examination Gloves, Powder Free, Pink Color | Shandong Yinghng Medical Products Co., Ltd. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231604 — Instrument Case | Cochlear Americas Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231680 — AccelFix Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230976 — Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223607 — Plum Duo Infusion System | Icu Medical, Inc. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223150 — APS Metal Plate & Screw System | A Plus Biotechnology Co., Ltd. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231557 — ZENEX FreeMilling & CCM Cast Abutment | Izenimplant Co., Ltd. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223606 — LifeShield Infusion Safety Software Suite | Icu Medical, Inc. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220145 — Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231274 — Natural Cycles | Natural Cycles Nordic AB Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232215 — Quantra Hemostasis Analyzer | Hemosonics, LLC Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232291 — Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232218 — Zenius Spinal System | Medyssey USA, Inc. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231506 — Current Health System | Current Health , Ltd. Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |