510(k) Clearances — Page 200
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222144 — IR SLA Type Implant System | Biotem Co., Ltd. Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223291 — Electronic Blood Pressure Monitor | Shenzhen Pango Medical Electronics Co., Ltd. Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222790 — F65 Laser System | Lumenis Be, Ltd. Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221540 — Synexis Sphere Rx | Synexis, LLC Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230567 — OptiVu ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231145 — Axis Anterior Cervical Plate System | Southern Medical (Pty) , Ltd. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223517 — Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223518 — iOrtho | Shanghai EA Medical Instruments Co., Ltd. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K201153 — Tisuthes e-PTFE Surgical Patch | Shanghai Suokang Medical Implants Co., Ltd. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230112 — CAC Software | Imbio, Inc. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) | Bosungmeditech Co., Ltd. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223669 — SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221888 — Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231022 — Pounce Thrombectomy System | Surmodics,Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231466 — RxSight Insertion Device | Rxsight, Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230397 — Cut Screw - Percutaneous Compression Screw | GM Dos Reis Industria e Comercio Ltda. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213754 — SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223361 — BMR 1900 PHISIO | Sorin Group Italia S.R.L. Sat Jun 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230776 — Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | Shenzhen Lutejiacheng Technology Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223091 — CT Perfusion V1.0 | Olea Medical Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230293 — TheraFace Mask | Therabody, Inc. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230586 — Renuvion® Micro Handpiece | Apyx Medical Corporation Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231359 — RODIN Expandable Lumbar Cage System | Ctl Medical Corporation Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230992 — DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231347 — BruxZir TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | Edwards Lifesciences, LLC Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220498 — NovoGen Wound Matrix | Novabone Products, LLC Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230512 — Gamma4 System | Stryker GmbH Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230779 — Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shanxi Hongjin Plastic Technology Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220078 — Eroxon | Futura Medical Developments Limited Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222450 — LVIS NeuroMatch | LVIS Corporation Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230905 — OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231037 — MyKnee UNI-ST | Medacta International S.A. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230892 — Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230744 — Acumed Acutrak 3 Headless Compression Screw System | Acumed, LLC Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230728 — JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231368 — Bemer Therapy System Evo | Bemer Int AG Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230502 — Ear Pressure Relief Device(Model:ER813B) | Ningbo Albert Novosino Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230768 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230505 — Orthopantomograph OP 3D LX | Palodex Group OY Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230709 — Auryon Atherectomy System | Eximo Medical, Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222001 — Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230008 — Ablamap® System | Ablacon, Inc. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231350 — OCD MT Cap (85-00397-000) | Neuronetics Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222762 — SIDDHARTH-II;IMPACT | Panacea Medical Technologies Pvt. , Ltd. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |