510(k) Clearances — Page 188
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K222993 — Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | Sentienx Sdn Bhd Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Stryker Corporation Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223163 — Sleepiz One+ | Sleepiz AG Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223573 — Onera Sleep Test System (Onera STS) | Onera B.V. Fri Aug 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230690 — Tandry Locking Plate System | Microware Precision Co., Ltd. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223167 — Spirair Nasal Septal Strap | Spirair, Inc. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230415 — Cadwell Guardian | Cadwell Industries, Inc. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222772 — Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230871 — EXTRON 5; EXTRON 7 | DRTECH Corporation Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231481 — Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222773 — Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230588 — Aer-O-Scope Colonoscope System | Gi View , Ltd. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223912 — InterCollagen® Guide | Sigmagraft, Inc. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223538 — Integrity Implant | Anika Therapeutics, Inc. Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230832 — Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232126 — EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil | Covidien Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223922 — SOMNUM (V.1.1.2.) | Honeynaps Co., Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230581 — TOPA12 Portable X-ray Unit | Neuf, Inc. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220073 — Revi System | Bluewind Medical , Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230298 — Celsi Monitor | Hadleigh Health Technologies Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231389 — Harvest Dental HD Gum Strip | Harvest Dental Products, LLC Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231087 — Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222148 — HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223709 — Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230342 — Phototherapy System (OL-PDT950) | Shanghai Omni Laser Skinology Co., Ltd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232141 — CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | Medtronic Sofamor Danek USA, Inc. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230314 — Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) | New Era Medicare Sdn. Bhd. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223479 — AQUAbase nX | B.Braun Medical, Inc. Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232116 — CoreLink Navigation Instruments | Corelink, LLC Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231491 — TA Stapler and Loading Unit with DST Series Technology | Covidien Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230577 — Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231750 — MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223874 — BAROguard | Paragonix Technologies Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231829 — Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231807 — primaLOK SP Interspinous Fusion System | Wenzel Spine, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231455 — Implant-One System | Implant Logistics, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231301 — Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231094 — Annalise Enterprise CTB Triage-OH | Annalise-Ai Pty , Ltd. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231838 — RxSight® Insertion Device (63002) | Rxsight, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232127 — 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231583 — Route 92 Medical Full Length 054 Access System | Route 92 Medical, Inc. Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231054 — V-Laser | Wontech Co., Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223660 — SaintView | Inviz Corporation Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231905 — Electro-Spec Steri-Caps | Electro-Spec, Inc. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231418 — ENDOGATOR Hybrid Irrigation Tubing | Medivators Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230607 — SPICCA Cervical Fusion Cages | Southern Medical (Pty) , Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231208 — Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232162 — Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | Boston Scientific Corporation Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231341 — Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230663 — Density | Jeisys Medical, Inc. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |