510(k) Clearances — Page 189
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232311 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231434 — DESS Dental Smart Solutions | Terrats Medical SL Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230608 — SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty) , Ltd. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231018 — Yomi Robotic System | Neocis, Inc. Mon Aug 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230756 — TK Pre-Filled Normal Saline Flush Syringe | Anhui Tiankang Medical Technology Co., Ltd. Sat Aug 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230172 — Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. Sat Aug 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223584 — Pre-Filled Normal Saline Flush Syringe | Anhui Tianyang Pharmaceutical Co., Ltd. Sat Aug 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223463 — Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223519 — Carex Hybrid Personal Lubricant | Karex Industries Sdn. Bhd. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223856 — NuEra Tight RF Family | Bios S.R.L. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231696 — Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230642 — Electronic Blood Pressure Monitor | Dongguan Kangweile Electronic Technology Co., Ltd. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230384 — PolyWear® Personal Protective Level 3 Gown | PolyConversions, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231493 — NITINEX Memory Compression Staple | Vilex, LLC Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231408 — Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile | Shandong Intco Medical Products Co, Ltd. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231823 — NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222888 — BlueStar CGM insulin dose calculator | Welldoc, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231439 — Powder Free White, Black, and Purple Nitrile Examination Glove | S&S Glove Corporation Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223840 — eRapid Nebulizer System | Pari Respiratory Equipment, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230632 — VersiHD with GuideMe software | Nxstage Medical, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230297 — PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230626 — Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | Ge Medical Systems Information Technologies, Inc. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231409 — Erchonia FX-405 | Erchonia Corporation Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230420 — Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. Fri Aug 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213131 — Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221925 — ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231415 — EnSite X EP System | ABBOTT MEDICAL Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223500 — SuperBall Meniscal Repair System | Arcuro Medical , Ltd. Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213134 — Accu-Chek Solo micropump system with interoperable technology | Roche Diabetes Care GmbH Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230625 — ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223711 — ANNE One | Sibel Health, Inc. Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223608 — GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223445 — ArtiFascia | Nurami Medical , Ltd. Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222850 — HAVAb IgG II | Abbott Laboratories Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230428 — Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 | Ambu A/S Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231380 — AirLife DuoTherm Humidification System | Vyaire Medical, Inc. Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231420 — Aura 10 PET/CT | Xeos Medical Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230268 — ZenPro 40 | BLUECORE COMPANY Co., Ltd. Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231164 — Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231167 — Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232039 — Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Grand Work Plastic Products Co., Ltd. Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho Clinical Diagnostics Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231885 — Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231114 — Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System | Zimmer Switzerland Manufacturing GmbH Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230304 — Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222443 — Air Smart Extra Spirometer | Feellife Health, Inc. Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231394 — Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231376 — Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | Smith & Nephew, Inc. Wed Aug 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232100 — Efai Pacs Picture Archiving and Communication System Pro | Ever Fortune.Ai, Co., Ltd. Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222128 — Protective Gown AAMI Level 4 | Kenpax International Limited Tue Aug 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |