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)
Get daily alerts for HRXSample briefCSV

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
Apr 6, 2019K182287MEDINAUT Plus
Imedicom Co., Ltd., KR
HRX
Apr 5, 2019K190598CROSSWAY Spinal Access System
Globus Medical, Inc.
HRX
Mar 8, 2019K190201CORUS Spinal System
Providence Medical Technology, Inc.
HRX
Jan 16, 2019K183165Pristine Scope
Pristine Surgical
HRX
Jan 7, 2019K183470Precision Ideal Eyes Arthroscopes
Stryker
HRX
Dec 21, 2018K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Stryker Corporation
HRX
Nov 14, 2018K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
Conmed Corporation
HRX
Nov 6, 2018K181819SMARTRELEASE Endoscopic Soft Tissue Release System
Microaire Surgical Instruments, LLC
HRX
Oct 2, 2018K181885Voyant System
Viseon, Inc.
HRX
Aug 21, 2018K181982MIDAScope and Introducer Kit, and MIDASystem
Intravu, Inc.
HRX
Jun 11, 2018K180766Endiscope, Endiscope Cervical
Elliquence, LLC
HRX
May 31, 2018K170703Single Use Arthroscopic Electrode (with Pencil)
Modern Medical Equipment Manufacturing Limited, CN
HRX
May 18, 2018K180876DTRAX Spinal System
Providence Medical Technology, Inc.
HRX
May 9, 2018K173311ARTHRO-Pump PA304
W.O.M. World of Medicine GmbH, DE
HRX
Mar 26, 2018K180315DISKOM
Biopsybell S.R.L., IT
HRX
Jan 25, 2018K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Stryker Corporation
HRX
Jan 18, 2018K171237FMS VUE II Fluid Management and Tissue Debridement System
Medos International SARL, CH
HRX
Oct 4, 2017K172092Reprocessed Shavers/Burs
Renovo, Inc.
HRX
Jun 27, 2017K171794Smith & Nephew 25 Fluid Management System
Smith & Nephew, Inc.
HRX
Mar 16, 2017K162070JOINIX CANNULAR SYSTEM
Aju Pharm Co., Ltd., KR
HRX
Feb 17, 2017K163037Intra medullary endo-transilluminating device (iMET device)
WeMED Bio-Tech, Inc., TW
HRX
Nov 1, 2016K162062AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
Stryker Corporation
HRX
Sep 26, 2016K161878PORTAGE System
Baylis Medical Company, Inc., CA
HRX
Sep 16, 2016K162475mi-eye 2, mi-eye 2 monitor
Trice Medical
HRX
Jul 11, 2016K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ c
Prosurg, Inc.
HRX
Apr 21, 2016K160249ULTRA Telescopes
Olympus Winter & Ibe GmbH, DE
HRX
Mar 31, 2016K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
Stryker Corporation
HRX
Mar 16, 2016K151268SPINAUT-V, SPINAUT-S, SPINAUT-I
Imedicom Co., Ltd., KR
HRX
Feb 22, 2016K153548VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Visionsense, Ltd., IL
HRX
Nov 24, 2015K151125AVAflex Vertebral Balloon System
Care Fusion
HRX
Oct 29, 2015K150523AVAmax Vertebral Balloon
Care Fusion
HRX
Jul 23, 2015K151532KYPHON ELEMENT Inflatable Bone Tamp
Medtronic, Inc.
HRX
Feb 20, 2015K143705NeedleCam HD Visualization System
Biovision Technologies, LLC
HRX
Dec 8, 2014K141557HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
Gallini Medical Devices, Srl
HRX
Oct 8, 2014K141326NEEDLE VIEW CH SCOPE KITS
Biovision Technologies, LLC
HRX
Jul 29, 2014K141119CAMERA ENABLED PROBE
Trice Medical, Inc.
HRX
Jul 17, 2014K140903NUVIS ARTHROSCOPE
Integrated Endoscopy, Inc.
HRX
Jun 26, 2014K141002VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Visionsense, Ltd.
HRX
Jun 2, 2014K133682SCHOELLY ARTHROSCOPE
Scholly Fiberoptic GmbH
HRX
Apr 18, 2014K133941MITEK ARTHROSCOPES
Medos International SARL, CH
HRX
Apr 14, 2014K130778DISCOSCOPES, CERVICAL ENDOSCOPES
Rz Medizintechnik GmbH, DE
HRX
Feb 26, 2014K133018OSI Q SYSTEM ARTHROSCOPES
Orthopedic Sciences, Inc.
HRX
Nov 27, 2013K133061ESPIN SYSTEM
Nlt Spine, Ltd.
HRX
Nov 1, 2013K132883HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
Hemodia Sas, FR
HRX
Oct 4, 2013K131820AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
Care Fusion
HRX
Oct 3, 2013K131824AVAFLEX VERTEBRAL BALLOON SYSTEM
Care Fusion
HRX
Jul 22, 2013K1311914MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
Depuy Mitek, A Johnson & Johnson Company
HRX
Jun 14, 2013K130912OMNICUT RESECTION BLADE
Depuy Mitek, A Johnson & Johnson Company
HRX
May 23, 2013K130430IVAS 10MM AND 15MM BALLOON CATHETER
Stryker Corporation
HRX
May 1, 2013K130169FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE
Depuy Mitek, A Johnson & Johnson Company
HRX

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.