510(k) Clearances — Page 114
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241951 — Lasya-Trinity | BLUECORE COMPANY Co., Ltd. Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242400 — Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242515 — uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240786 — AutoChamber | HeartLung Corporation Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care US Medical Product Co., Ltd. Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231948 — MEDIYAG | Medicreations, LLC Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240991 — eMVFit (MVF-10M) | Weero Co., Ltd. Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242029 — TRAP EASY | H.S Hospital Service S.P.A Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241485 — TruAbutment DS; TruBase | Truabutment, Inc. Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242021 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Thermo Fisher Scientific Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242691 — OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241477 — aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241837 — Limbus Contour | Limbus Ai, Inc. Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240181 — Clavicle and Scapula System | Auxein Medical Pvt., Ltd. Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241355 — SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242826 — ProLift Wedge Expandable Spacer System | Life Spine, Inc. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241446 — Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241756 — Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240563 — Power Wheelchair (JJW-6001) | ZheJiang J&J Mobility Co., Ltd. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242267 — Gemini Medical Cage System | ZheJiang Decans Medical Devices Co., Ltd. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242391 — Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Lucens Technology Co., Ltd. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230076 — Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | Omron Healthcare, Inc. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242014 — Jet Flow Bulk | Meta Biomed Co., Ltd. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240167 — Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240843 — GENESIS (MS-P02-GEN) | Climbing Steps, Inc. Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240029 — Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240980 — EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242457 — EARP Interbody System | Retropsoas Technologies, LLC Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242084 — EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242746 — OvertureTi Knee Resurfacing SystemTM | Overture Orthopaedics Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242693 — DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242375 — OR3O Dual Mobility System | Smith & Nephew, Inc. Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | Huizhou Foryou Medical Devices Co., Ltd. Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241029 — SpineUs System | Verdure Imaging Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242357 — Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corporation Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | Stryker GmbH Sun Oct 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242721 — Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | Shenzhen Finicare Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240675 — Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242351 — Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242679 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | Fengh Medical Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242106 — AuST Steerable Sheath | CenterPoint Systems, LLC Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240553 — LVivo Software Application | Dia Imaging Analysis, Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241052 — Bladeless Trocar; Bladed Trocar; Hasson Trocar | Advamedix, GmbH Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241854 — Power Wheelchair | Anhui Jbh Medical Apparatus Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241796 — TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241298 — QUADSENSE | Eventum Orthopaedics, Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |