510(k) Clearances — Page 121
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241256 — JetBoots PRO Plus | Therabody, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242346 — Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241881 — IPL Hair Removal Device (JM-843, JM-865, JM-638) | Shenzhen Junmei Technology Co., Ltd. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242296 — VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK) | Ortho-Design (Pty), Ltd. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240105 — Navigator (FMNVG15); Navigator XL (FMNVX06) | Forcemech International, LLC Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241400 — SkinPen Precision Elite System | Crown Aesthetics Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233826 — Kosmos | EchoNous, Inc. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips | Stryker Spine Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220908 — Ensol EnTM Specimen Collection and Transport System | Ensol Biosciences, Inc. Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241227 — RHYTHMIA HDx Mapping System | Boston Scientific Corporation Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242243 — Target Detachable Coils | Stryker Neurovscular Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240545 — GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) | Genabio Diagnostics, Inc. Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Sleepnet Corporation Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241932 — OSSIOfiber® Compression Staple | OSSIO , Ltd. Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241457 — Vista BC Putty | Inter-Med, Inc. Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241913 — da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240078 — Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230067 — Chronos® | Germitec Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233827 — OxiWear | Oxiwear, Inc. Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242316 — Safety Lancet | Ningbo Medsun Medical Co., Ltd. Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241557 — Cercon® yo ML | Dentsply Sirona Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233816 — REDEMPTION Charcot Plating System | Vilex, LLC Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232991 — BT-1000 | Bistos Co., Ltd. Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241517 — Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241228 — TENSWave | Zynex Medical Officer Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241241 — Z1 Cemented Hip System | Orchard Medical Development, LLC Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242537 — BracePaste Fluoride Sealant | American Orthodontics Corp. Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241684 — Overjet Charting Assist | Overjet, Inc. Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233846 — Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234151 — Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240270 — Electric wheelchair (S7018) | Guangdong Prestige Technology Company Limited Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241354 — Sealer Solvent | Inter-Med, Inc. Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241777 — SmartAdjust Technology | Insulet Corporation Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241538 — TriClip Steerable Guide Catheter | ABBOTT MEDICAL Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242044 — FiAPC plus probes | Erbe Elektromedizin GmbH Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240982 — DESS Dental Smart Solutions | Terrats Medical SL Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241607 — MyoStrain (6.0) | Myocardial Solutions, Inc. Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241858 — BARS Set (100.60) | Ovesco Endoscopy AG Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242169 — Morph DNA Steerable Introducer Sheath | Biocardia Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240318 — SITTER 3.5mm Versatile System | Bonebridge AG Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242202 — LightWalker Laser System Family | Fotona D.O.O. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241780 — Cardinal Health Nitrile Exam Gloves | Cardinal Health200, LLC Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241492 — Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233358 — SCoV-2 Ag Detect Rapid Test | InBios International, Inc. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |