510(k) Clearances — Page 122
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241302 — SonoSync | Samsung Medison Co., Ltd. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242264 — TMINI Miniature Robotic System | THINK Surgical, Inc. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231100 — Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw | Proimtech Saglik Urunleri Anonim Sirketi Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240896 — ONE Nitrile Condom | Global Protection Corp. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242191 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240790 — Polyisoprene Surgical gloves | Suzhou Colour-Way New Material Co., Ltd. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240593 — VEEGix EEG System | NeuroServo, Inc. Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233829 — Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) | Fisher and Paykel Healthcare Limited Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241803 — INSULCLOCK® v2.0 PRO | Insulcloud S.L. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241098 — NeuroQuant | Cortechs Labs, Inc. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242248 — Introducer Sheath Kits | Beijing Demax Medical Technology Co.,Ltd Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242126 — I.V. Administration Set | Bq Plus Medical Co., Ltd. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241804 — TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241979 — Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) | Beijing Konted Medical Technology Co.,Ltd Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240227 — LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) | Lina Medical Aps Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234128 — Phantom Fibula Nail System | Paragon 28, Inc. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234076 — iCare ALTIUS CW | Centervue S.P.A. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230071 — Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System | Tdm Co., Ltd. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241369 — LIJIA Night Guard | Lijia, LLC Thu Aug 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241351 — Blood Pressure Monitor (TMB-2092-G) | Guangdong Transtek Medical Electronics Co., Ltd. Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242141 — TiLink-P SI Joint Fusion System | SurGenTec, LLC Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240314 — MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242066 — iSage Rx | Amalgam Rx, Inc. Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240298 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233566 — Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240859 — Glidewire GT-R | Terumo Corporation Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241061 — VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240290 — AiMIFY (1.x) | Subtle Medical, Inc. Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242142 — Fraxel® FTX Laser System | Solta Medical Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233391 — cCeLL - In vivo | VPIX Medical, Inc. Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241080 — Kerecis Parvus (50207) | Kerecis Limited Wed Aug 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242189 — CELERITY HP Indicator Tape (PCC077) | Steris Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241738 — PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | Covidien Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231932 — TDS (TECHWIN DENTAL SYSTEM) | Techwin Co., Ltd. Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241848 — MedtFine Safety Lancet | Ningbo Caremed Medical Products Co., Ltd. Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241496 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242134 — ClearCap Distal Attachment | Finemedix Co., Ltd. Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241102 — Luna 4 plus | Foreo, Inc. Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234114 — CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) | Okapi Medical, LLC Dba Resivant Medical Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241282 — RibFix Titan Fixation System | Riverpoint Medical Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242432 — MT-Bone | Mectron S.P.A. Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240235 — OmniTrans Transport System | Shenzhen Dakewe Bio-Engineering Co., Ltd. Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA Mon Aug 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |