510(k) Clearances — Page 112
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242554 — Arthrex VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241170 — Dynamic TiBase; TRI Screws | Talladium España, SL Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | 3M Company Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242828 — Corplex P/ Theracor P/ Allacor P | Stimlabs, LLC Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233378 — ABCcolla® Collagen ADM Scaffold | Acro Biomedical Co., Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240844 — Spectral CT 7500 RT | Philips Medical Systems Technologies , Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242868 — Kinos Total Ankle System | Restor3D Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242372 — Mg OSTEOREVIVE, Mg OSTEOCRETE | Bone Solutions, Inc. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232994 — Vittra APS Unique Flow | Dentscare Ltda Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242837 — BriefCase-Triage | Aidoc Medical , Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242435 — Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243033 — dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture | Safepath Medical, Inc. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241131 — edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | Edelweiss Dentistry Products GmbH Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233054 — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator | Well-Life Healthcare Limited Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241490 — Contour+ (MVision AI Segmentation) | Mvision AI OY Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242864 — ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240226 — Pixie Skin Tag | Oystershell NV Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242879 — dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240725 — PreXolid CAD/CAM abutments | Eclectic Co., Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242132 — FREDDO | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240916 — Surgical Face Mask (Tie on/ Ear loops) | Xiantao Daoqi Plastic Co., Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242813 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | Sleepnet Corporation Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | Coloplast Corp. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | Boston Scientific Corp Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240321 — MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241267 — Hidroxa SE30 | Hidroxa Medical AB Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240218 — Electric Breast Pump (F5055) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242899 — NOVA Minimally Invasive System | Baui Biotech Co., Ltd. Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242809 — Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240711 — Zipline Access Catheter | Perfuze, Ltd. Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241337 — Electrically powered wheelchair (HP202) | Kunshan Hi-Fortune Health Products Co., Ltd. Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K211943 — Microlyte Ag/Lidocaine | Imbed Biosciences Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240160 — EGPS Navigated Instruments | Astura Medical Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242197 — IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) | Shenzhen Huaruibo Electric Appliances Co., Ltd. Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241242 — SIGNA MAGNUS | Ge Medical Systems, LLC Thu Oct 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241632 — Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242784 — Vy Spine VyLam Laminoplasty System | Vy Spine, LLC Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241221 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242794 — ONCOZENE Microspheres | Varian Medical Systems, Inc. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240468 — Alkaline Phosphatase | Abbott Laboratories Diagnostics Division Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242839 — Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241272 — Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241481 — xvision Spine System | Augmedics, Ltd. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242556 — JLK-CTP | JLK, Inc. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240849 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2 | Ambu A/S Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241613 — Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) | Shenzhen Hbcare Technology Co.,Ltd Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240596 — Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |