510(k) Clearances in 2018 — Page 13
Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.
| 510(k) clearances | Details |
|---|---|
| K182464 — PeekMed | Peek Health, S.A. Oct 25, 2018 |
| K181685 — Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound And Primary Care Diagnostics Oct 25, 2018 |
| K180688 — SLENDERTONE CoreFit Abs 8, Type 734 | Bio-Medical Research, Ltd. Oct 25, 2018 |
| K180258 — SpeediCath Standard | Coloplast Oct 25, 2018 |
| K181902 — Codman Certas Plus Electronic Tool Kit | Integra Lifesciences Corp. Oct 25, 2018 |
| K182318 — Retina Workplace | Carl Zeiss Meditec, Inc. Oct 24, 2018 |
| K180275 — VAMP Optima closed blood sampling system | Edwards Lifesciences, LLC Oct 24, 2018 |
| K182322 — Duo Lumbar Interbody Fusion Device | Spineology, Inc. Oct 24, 2018 |
| K181530 — World Total Knee System | Signature Orthopaedics Pty, Ltd. Oct 24, 2018 |
| DEN180004 — picoAMH ELISA | Ansh Labs, LLC Oct 24, 2018 |
| K180605 — GastroFlush | Bionix Development Corporation Oct 24, 2018 |
| K180758 — Osteocera Resorbable Bone Substitute | Wiltrom Corporation Limited Oct 24, 2018 |
| K182281 — Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech | C. R. Bard Oct 24, 2018 |
| K181560 — Cios Alpha | Siemens Medical Systems USA, Inc. Oct 24, 2018 |
| K180940 — KODEX EPD System | Philips Medical Systems Nederland B.V. Oct 24, 2018 |
| K180302 — Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter | Cook Incorporated Oct 24, 2018 |
| K180788 — Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 24, 2018 |
| K182365 — TempSure System | Cynosure, Inc. Oct 24, 2018 |
| K181596 — Spine Wave Navigated Instruments | Spine Wave, Inc. Oct 24, 2018 |
| K173756 — Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. Oct 24, 2018 |
| K182647 — GC70 | Samsung Electronics Co., Ltd. Oct 24, 2018 |
| K182140 — da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. Oct 24, 2018 |
| K173603 — Monarch Airway Clearance System | Hill-Rom Holdings, Inc. Oct 24, 2018 |
| K180046 — Masimo Rad-97 and Accessories | Masimo Corporation Oct 23, 2018 |
| K181964 — JiveX | Visus Health IT GmbH Oct 23, 2018 |
| K172670 — BD Single Use, Hypodermic Syringe | Becton, Dickinson And Company Oct 23, 2018 |
| K182002 — Cumulus Remover | Kitazato Corporation Oct 23, 2018 |
| K182042 — Randox Calcium (Ca) | Randox Laboratories, Ltd. Oct 23, 2018 |
| K182529 — Xperius Ultrasound System | Philips Ultrasound, Inc. Oct 23, 2018 |
| K182622 — GU60A, GU60A-65 | Samsung Electronics Co., Ltd. Oct 23, 2018 |
| K180622 — Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port | Covidien Oct 23, 2018 |
| K182283 — FUSE Pedicle Screw System | Black Box Medical Oct 23, 2018 |
| K173824 — Humeral Short Stem System | Shoulder Innovations, Inc. Oct 23, 2018 |
| K182106 — BTL 799-2T | BTL Industries, Inc. Oct 23, 2018 |
| K181248 — Comarch e-Care Platform | Comarch Healthcare SA Oct 22, 2018 |
| K181922 — Sonendo Material A | Sonendo, Inc. Oct 22, 2018 |
| K180554 — ANTHEM Fracture System | Globus Medical, Inc. Oct 22, 2018 |
| K172533 — GM Implant Tubes, Length Cutting Gauge | Varian Medical Systems, Inc. Oct 22, 2018 |
| K172733 — TD-1035 Thermometer | Taidoc Technology Corporation Oct 22, 2018 |
| K181566 — Nutrifill | Contamac, Ltd. Oct 22, 2018 |
| K181254 — Quadra P | Medacta International S.A. Oct 22, 2018 |
| K181192 — PIP Fix | Hand Biomechanics Lab, Inc. Oct 22, 2018 |
| K181223 — ImPACT | Impact Applications, Inc. Oct 20, 2018 |
| K180516 — EchoS | Echolight S.P.A Oct 19, 2018 |
| K182561 — UroNav (Version 3.0) | Invivo Corporation Oct 19, 2018 |
| K180205 — AVELLE Negative Pressure Wound Therapy System | Convatec Limited Oct 19, 2018 |
| K173594 — Straumann cerabone | Institut Straumann AG Oct 19, 2018 |
| K182282 — Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation Oct 19, 2018 |
| K182735 — Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies Oct 19, 2018 |
| K182264 — ICONN Revolution Knotless Suture Anchor | Iconn Orthopedics, LLC Oct 19, 2018 |