510(k) Clearances — Page 153
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233879 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) | Maquet Cardiovascular, LLC Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233972 — Camber Sacroiliac (SI) Fixation System | Camber Spine Technologies Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233623 — Praxiject SP 0.9% NaCl | Medxl, Inc. Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233435 — Peace N Quiet (0.7.0) | Pnq Health Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232522 — ARK Levetiracetam II Assay | Ark Diagnostics, Inc. Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234014 — Obsidian® NOW | Prismatik Dentalcraft, Inc. Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232607 — 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM | Solco Biomedical Copany India Private Limited Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230782 — TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology, Inc. Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233560 — Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid | Eco Medi Glove Sdn. Bhd. Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233675 — FMS VUE Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232628 — VADER® Pedicle System | Icotec AG Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230693 — BIS Advance Monitoring System | Covidien, LLC Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231822 — GOLFF Sterile Anti-Fog Solution | Batrik Medical Manufacturing, Inc. Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232084 — Stellaris Elite vision enhancement system | Bausch and Lomb Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234133 — Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. Mon Feb 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233709 — Exceed Unlimited | Mt. Derm GmbH Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232536 — Soldier Microcatheter | Embolx, Inc. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232800 — Navigation Tracking Instruments | SI-BONE, Inc. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233590 — Overjet Charting Assist | Overjet, Inc. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240213 — Iconix Knotless Anchor | Riverpoint Medical Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233754 — AIO Breathe | Aiomega, LLC Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233722 — RADspeed Pro | Shimadzu Corporation Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240201 — PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230423 — Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | Shenzhen Konmed Technology Co., Ltd. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240011 — Lymphedema Compression | Jkh Health Co., Ltd. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232075 — StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Genoss Co., Ltd. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233995 — Ivotion Base Print | Ivoclar Vivadent, Inc. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230025 — MIRA Surgical System | Virtual Incision Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233784 — ENSO (Model 2) | Hinge Health, Inc. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240212 — COGNiTiON Staple System | Ortho Solutions UK , Ltd. Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231876 — MultiPulse HoPLUS | Asclepion Laser Technologies GmbH Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232163 — Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | Zhejiang Horizon Medical Technology Co., Ltd. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232831 — Quiver Aspiration Pump | Anoxia Medical, Inc. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232074 — Serafin® | Tns Co., Ltd. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233544 — MESHEET | Dentis Co., Ltd. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240313 — Oligio X | Wontech Co., Ltd. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233749 — Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | Sorin Group Italia S.R.L. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223826 — NanoDrop Lancet | Drawbridge Health, Inc. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233640 — Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | Alphatec Spine, Inc. Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240174 — 1688 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233775 — Vivatmo pro | Bosch Healthcare Solutions GmbH Thu Feb 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |