510(k) Clearances — Page 142
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232528 — Protective Cap | Neobiotech Co., Ltd. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233403 — Flexset System | Zeto, Inc. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232923 — Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems, Inc. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232889 — METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240118 — Picosecond Nd:YAG Laser System | Smedtrum Medical Technology Co., Ltd. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | Physio-Control, Inc. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233231 — Dental Implants and Abutments | Ditron Dental, Ltd. Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240621 — Morpheus® Moldable; Agilon® Moldable | Biogennix, LLC Tue Apr 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | Surgical Instrument Service and Savings, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240591 — restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240248 — Volnewmer | Classys, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233699 — SubtleREFORMAT (1.x) | Subtle Medical, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230052 — Eversense AP CGM System | Senseonics, Incorporated Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240568 — DuraPro Oscillating System | Globus Medical, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240062 — ARVIS® Shoulder | Insight Medical Systems, Inc. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240526 — POWEReam Xia/Serrato | Stryker Instruments Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240102 — Blood Pressure Monitor (TMB-2287-B) | Guangdong Transtek Medical Electronics Co., Ltd. Mon Apr 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240872 — Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232038 — BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233673 — uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240091 — NB Mini Implant System | Arum Dentistry Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232302 — Pocket III | Quantel Medical Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240566 — Reef L Interbody System; WaveForm L Interbody System | SeaSpine Orthopedics Corporation Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Urit Medical Electronic Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232261 — TME Temporary Myocardial Electrode | Osypka AG Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233703 — Bone Anchor (NGS-BA-01) | ClearPoint Neuro, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221688 — ASTar BC G- Kit and ASTar Instrument | Q-Linea AB Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232298 — DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220272 — cobas pulse blood glucose monitoring system | Roche Diagnostics Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240324 — EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232435 — Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240406 — Sonio Detect | Sonio Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233583 — FCT iSTREAM Phase 1 | FUJIFILM Healthcare Americas Corporation Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232799 — syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233873 — XLO Brand of Locking Distal Humerus Plating System | Ortho Life Systems Private Limited Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240299 — Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer, Inc. Fri Apr 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231142 — Temporis, Irix Plus | Dws S.R.L. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232357 — Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232405 — ENDOFIX EXO | Aktormed GmbH Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240535 — Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233810 — Portrait VSM | Ge Medical Systems Information Technologies, Inc. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232331 — InVision Precision LVEF (LVEF) | InVision Medical Technology Corporation Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232805 — Kronos Electrocautery Device | Single Pass, Inc. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240846 — CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement | CarboFix Orthopedics , Ltd. Thu Apr 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |