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
Feb 11, 2013K122411J-SCOPE SYSTEM
Myelotec
HRX
Feb 7, 2013K130057ESPIN
Nlt Spine, Ltd.
HRX
Jan 9, 2013K123441STRYKER CROSSFLOW ARTHROSCOPY PUMP
Stryker Endoscopy
HRX
Jan 8, 2013K121261ASAP MUITISCOPE
Asap Endoscopic Products GmbH, NL
HRX
Dec 27, 2012K122134FLEXLITE CAMERA
Spine View, Inc.
HRX
Dec 21, 2012K123771KYPHON EXPRESS II INFLATABLE BONE TAMPS
Medtronic
HRX
Dec 7, 2012K122861XTOOL
Ouroboros Medical
HRX
Nov 13, 2012K122662VERTIFLEX DIRECT DECOMPRESSION SYSTEM
Vertiflex, Inc.
HRX
Aug 28, 2012K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
Theken Spine, LLC
HRX
Aug 16, 2012K121548SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
Spine View, Inc.
HRX
Aug 15, 2012K112548ALTOMEC ARTHROSCOPE
Altomec Endoscopy, Inc.
HRX
Aug 9, 2012K120553ESPIN
Nlt Spine, Ltd.
HRX
Jun 26, 2012K120680ENSPIRE DISCECTOMY SYSTEM
Spine View, Inc.
HRX
Apr 16, 2012K113352TRANSCORP SPINAL ACCESS SYSTEM
Transcorp, Inc.
HRX
Feb 10, 2012K113362SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
Spine View, Inc.
HRX
Dec 20, 2011K113028MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
Medisiss
HRX
Oct 21, 2011K110992ENSPIRE DEBRIDER SYSTEM
Spine View, Inc.
HRX
Jan 24, 2011K103231KYPHON INFLATION SYRINGE
Medtronic Spine, LLC
HRX
Oct 18, 2010K093471KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
KARL STORZ Endoscopy-America, Inc.
HRX
Oct 14, 2010K101864KYPHON XPANDER II INFLATABLE BONE TAMP
Medtronic
HRX
Oct 4, 2010K092723AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM
Skeletal Dynamics, LLC
HRX
Sep 29, 2010K092977EBERLE SHAVER SYSTEM ACCESSORIES
Efs Eberle Feinwerktechnische Systeme
HRX
Sep 8, 2010K101734VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
Visionscope Technologies, LLC
HRX
Mar 5, 2010K093677STRYKER ARTHROSCOPE
Stryker Endoscopy
HRX
Mar 2, 2010K093717C-MOR VISUALIZATION DEVICE
Axis Surgical Technologies, Inc.
HRX
Feb 24, 2010K093409POWERPUMP ARTHROSCOPY SYSTEM
Medical Vision AB
HRX
Feb 4, 2010K093062VERTOS MEDICAL MILD DEVICE KIT
X-Sten Corp.
HRX
Nov 17, 2009K092877INDISCAL ASPIRATION DEVICE AND ACCESSORIES
Baylis Medical Co., Inc., CA
HRX
Oct 9, 2009K083552MAXMORESPINE TOM STICK
Hoogland Spine Products, GmbH, DE
HRX
Sep 9, 2009K082841SPINAL FORAMINOSCOPE
Blazejewski Medi-Tech GmbH, NL
HRX
Aug 26, 2009K091398ARTHROSCOPE
Orthopedic Sciences, Inc.
HRX
Aug 3, 2009K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
Arthrex, Inc.
HRX
Jun 9, 2009K090132MAXMORESPINE SPINAL SYSTEM
Hoogland Spine Products, GmbH, DE
HRX
May 21, 2009K090815PERCUTANEOUS DISCECTOMY SYSTEM
Laurimed, LLC
HRX
Apr 30, 2009K090303XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
Corespine Technologies, LLC
HRX
Apr 15, 2009K090278ENSPIRE DEBRIDER SYSTEM
Spine View, Inc.
HRX
Mar 27, 2009K083161ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
Conmed Linvatec
HRX
Feb 27, 2009K081240TIGER DISCECTOMY DEVICE
Spinal Devices, LLC
HRX
Dec 15, 2008K082355VISIONSENSE STEREOSCOPIC VISION SYSTEM
Visionsense, Ltd.
HRX
Sep 9, 2008K082293SURGVIEW INTEGRATED VISUALIZATION SYSTEM
Biovision Technologies, LLC
HRX
Aug 28, 2008K082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
Laurimed, LLC
HRX
Aug 7, 2008K081051SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
Spine View, Inc.
HRX
Jul 11, 2008K080122SOPRO 670 ARTHROSCOPIC PUMP
Sopro
HRX
Jun 27, 2008K080617POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
Richard Wolf Medical Instruments Corp.
HRX
Jun 6, 2008K072198X-VOID, SPIDER
Sintea Biotech, Inc.
HRX
Mar 18, 2008K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPE
Henke Sass Wolf of America, Inc.
HRX
Jan 14, 2008K072879INNERVUE DIAGNOSTIC SCOPE SYSTEM
Biomet Orthopedics, Inc.
HRX
Dec 7, 2007K070021ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
Jg Medical Products, LLC
HRX
Nov 2, 2007K070874ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR
Arthro Kinetics, Inc.
HRX
Oct 24, 2007K072706MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
Conmed Linvatec
HRX

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