510(k) Clearances — Page 178
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230144 — Denti.AI Detect | Denti.Ai Technology, Inc. Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | Xeridiem Medical Devices, A Spectrum Plastics Group Company Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231001 — DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | Biomérieux Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230780 — MFG-05 | Zimmer Medizinsysteme GmbH Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221550 — Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232367 — cmAngio® V1.0 | Curemetrix, Inc. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232279 — LifeStyles NRL Textured Condom | Suretex Limited Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223740 — Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233044 — Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231078 — All-Suture Anchor | Riverpoint Medical, LLC Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230070 — MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® | Promamedical, Inc. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232704 — Clarius Ultrasound Scanner | Clarius Mobile Health Corp. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230242 — OsteoCentric Dental Implant System | OsteoCentric Technologies Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232675 — Heating Tens, FT-615 | Hivox Biotek, Inc. Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231025 — EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232023 — Momentum Spine | Momentum Health, Inc. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232763 — Electrode Handpieces (VCT, RFTV, BMDT series) | RF Medical Co., Ltd. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232844 — The IQoolTM System | Braincool AB Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232767 — Nautilus VF ECMO Oxygenator | Mc3, Inc. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230135 — Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231398 — VUNO Med-DeepBrain | Vuno, Inc. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231567 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) | Better Care Plastic Technology Co., Ltd. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230002 — DuraGraft | Marizyme, Inc. Wed Oct 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | STERIS Corporation Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231772 — V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232094 — Orchid Safety Release ValveTM | Linear Health Sciences, LLC Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232406 — KARL STORZ OR1 SCB CONTROL (WU300) | Karl Storz SE & CO. KG Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232722 — endo.digital Platform | DreaMed Diabetes, Ltd. Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232918 — enspire 300 Series Automated Endoscope Reprocessor | STERIS Corporation Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232762 — dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232712 — uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231960 — NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Anx Robotica Corporation Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230085 — Lung-CAD | Imagen Technologies, Inc. Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | Zhenjiang Assure Medical Equipment Co., Ltd. Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232064 — Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) | Isikel Manufacturing, LLC Mon Oct 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232359 — Surgical face mask | Kingstar Medical (Xianning) Co., Ltd. Mon Oct 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221972 — Warantec Custom Abutment | Warantec Co., Ltd. Mon Oct 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230681 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | Central Medicare Sdn Bhd Mon Oct 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231716 — OsteoFlo® HydroPutty | SurGenTec, LLC Mon Oct 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231520 — tmCMF Solution | Techmah Cmf Mon Oct 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221890 — Elecsys Tg II | Roche Diagnostics Sat Sep 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223085 — Miris Human Milk Analyzer (HMA) | Miris AB Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221274 — StarFormer, TightWave | Fotona D.O.O. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230591 — TriLEAP Plating System | Crossroads Extremity Systems Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232690 — Amulet Steerable Delivery Sheath | ABBOTT MEDICAL Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212769 — DYNEX SmartPLEX MMRV IgG Assay Kit | Dynex Technologies, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220023 — Procise ADL | Procisedx, Inc. Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |