ClearanceBrief
Panels › Orthopedic › Product code HRX · Class 2

Arthroscope

Regulation 888.1100

10510(k)s in 12 months (685 all time)
0recalls in 12 months (126 all time)
103recalls that name a 510(k)
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Top companies in HRX

Company510(k)sRecalls
KARL STORZ Endoscopy-America, Inc.280
Arthrex, Inc.270
Stryker1215
Acufex Microsurgical, Inc.260
Ascent Healthcare Solutions022
Smith & Nephew192
Linvatec Corp.191
Stryker Endoscopy117
Linvatec Corp. dba ConMed Linvatec017
Richard Wolf Medical Instruments Corp.143
Decided510(k)Device and applicantCode
Oct 14, 2026K263208Vantage Lumbar Decompression Kit
SurGenTec, LLC
HRX
Oct 9, 2026K260156TruVision Single-Use 1.9mm Arthroscopy System
Nexus CMF, LLC
HRX
Aug 28, 2026K260203Fule Vertebroplasty Balloon Catheter
Beijing Fule Science & Technology Development Co., Ltd., CN
HRX
Aug 26, 2026K254103HOPKINS Telescopes for Arthroscopy
Karl Storz SE & CO. KG, DE
HRX
May 26, 2026K252790Digital ClarusScope System and Digital NeuroPEN System
Clarus Medical, LLC
HRX
Apr 16, 2026K253523Freedom DS™ Decompression System
Spinal Simplicity
HRX
Mar 12, 2026K252546VantageTM Lumbar Decompression Kit
Allevion Medical, LLC
HRX
Dec 23, 2025K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display S
Medimaging Integrated Solution, Inc (Miis), TW
HRX
Dec 5, 2025K250795PUREVUE™ FMS
W.O.M. World of Medicine GmbH, DE
HRX
Nov 21, 2025K252666Articulator Arthroscopic Bur
Joint Preservation Innovations, LLC
HRX
Nov 3, 2025K252458Kyphoplasty Balloon Dilatation Catheters
Shanghai Lange Medtech Co., Ltd., CN
HRX
Oct 15, 2025K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
Hand Biomechanics Lab, Inc.
HRX
Sep 29, 2025K252594UltraGuideCTR® image guided soft tissue release system
Sonex Health
HRX
Aug 27, 2025K243774ELID (Endoscopic Less Invasive Decompression) System
Lesspine Innovations
HRX
Jul 30, 2025K241990SpineSite Endoscope System
Hydrocision, Inc.
HRX
May 16, 2025K243602Arthrex Spine Endoscope
Arthrex, Inc.
HRX
Dec 11, 2024K242417VECTR – Video Endoscopic Carpal Tunnel Release System
Rafael Medical Devices, LLC
HRX
Dec 2, 2024K243020MIDASVu
Intravu, Inc.
HRX
May 6, 2024K233800Vertos mild Device Kit (MDK-0002)
Vertos Medical, Inc.
HRX
Apr 25, 2024K240535Digital ClarusScope System; Digital NeuroPEN System
Clarus Medical, LLC
HRX
Feb 26, 2024K233675FMS VUE™ Fluid Management and Tissue Debridement System
DePuy Mitek, Inc.
HRX
Feb 6, 2024K233115Hawkeye Control Unit with Eyas Endoscope
E Surgical, LLC
HRX
Aug 16, 2023K223709Kyphoplasty Balloon Catheter
Jiangsu Changmei Medtech Co., Ltd., CN
HRX
Apr 21, 2023K221142Kyphoplasty Balloon System
OK Medinet Korea Co., Ltd., KR
HRX
Mar 9, 2023K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
Hemodia Sas, FR
HRX
Feb 2, 2023K223406SmartRelease Endoscopic Soft Tissue Release System
Microaire Surgical Instruments
HRX
Dec 21, 2022K223244Pristine Arthroscopic Visualization System
Pristine Surgical
HRX
Nov 14, 2022K222490HBL Blade Assembly
Hand Biomechanics Lab, Inc.
HRX
Oct 18, 2022K213978TELIGEN System
Medos International SARL, CH
HRX
Oct 15, 2021K212636CORUS Spinal System-X
Providence Medical Technology, Inc.
HRX
Sep 15, 2021K212556mi-eye 3 needlescope with cannula, mi-tablet 3
Trice Medical, Inc.
HRX
Jun 24, 2021K211297SMARTRELEASE Endoscopic Soft Tissue Release System
Microaire Surgical Instruments
HRX
Apr 5, 2021K203480DOUBLEFLO system
Hemodia Sas, FR
HRX
Feb 3, 2021K202027Balex bone Expander System
Taeyeon Medical Co., Ltd., KR
HRX
Jan 15, 2021K193608EBERLE Shaver System C3 and Accessories
Eberle GmbH & Co. KG, DE
HRX
Jan 12, 2021K203526C Scope Visualization System
Cit Ortho
HRX
Dec 21, 2020K201113Resascope RS-01/B
Advanced Medical Systems Group Srl, IT
HRX
Dec 1, 2020K202659Stryker Arthroscope
Stryker
HRX
Oct 9, 2020K192921Zeos Aqua Vision Pump and tube
Hemodia Sas, FR
HRX
Oct 1, 2020K200067MectaScope System
Medacta International S.A., CH
HRX
Aug 12, 2020K200763Osteo-site Vertebral Balloon
Izi Medical
HRX
Jul 20, 2020K201349Smith+Nephew Arthroscopes
Smith & Nephew
HRX
Apr 16, 2020K200729HydroCision SpineJet System
Hydrocision, Inc.
HRX
Oct 9, 2019K191596Arcadia Balloon Catheter
Merit Medical Systems, Inc.
HRX
Sep 4, 2019K192155Smith & Nephew DYONICS 25 Fluid Management System
Smith & Nephew, Inc.
HRX
Jul 17, 2019K191345Pegasus System
A.M. Surgical, Inc.
HRX
Jul 12, 2019K191259Stryker CrossFlow Integrated Arthroscopy Pump
Stryker Corp.
HRX
Jul 11, 2019K191594Nuvis Battery Arthroscope
Integrated Endoscopy, Inc.
HRX
Jul 11, 2019K191579Voyant System
Viseon, Inc.
HRX
Jun 5, 2019K190804HydroCision TenJet Device
Hydrocision, Inc.
HRX

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