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
DateFirm and productCodeLinked 510(k)
Sep 21, 2009Smith & Nephew, Inc. Endoscopy Division
DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005
Terminated		 HRXK051326
May 11, 2009Medtronic Spine LLC, formerly Kyphon Inc
KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.
Terminated		 HRXK041454
Jan 21, 2009Stryker Endoscopy
Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
Terminated		 HRXK944210
Jan 16, 2009Stryker Endoscopy
Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-
Terminated		 HRXK944210
Sep 21, 2008Smith & Nephew, Inc. Endoscopy Division
DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field.
Terminated		 HRXK051326
Sep 21, 2008Smith & Nephew, Inc. Endoscopy Division
DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Inflow/Outflow Tubeset with Forked Suction. Catalog # 7211006. Bag is used for remote control i
Terminated		 HRXK051326
Sep 21, 2008Smith & Nephew, Inc. Endoscopy Division
DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow/Outflow Tubeset with Single Suction. Catalog # 7211005. Bag is used for remote in a ster
Terminated		 HRXK051326
Sep 21, 2008Smith & Nephew, Inc. Endoscopy Division
DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field.
Terminated		 HRXK051326
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope.
Terminated		 HRXK012695
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope.
Terminated		 HRXK012640
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope.
Terminated		 HRXK012695
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope.
Terminated		 HRXK043198
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Arthrocare 3.6 mm Right Angle - Reprocessed Sterile device -- Orthopedic Arthroscope.
Terminated		 HRXK012695
Sep 19, 2008Ascent Healthcare Solutions, Inc.
Mitek 3.5 mm Side Effect Electrode - - Reprocessed Sterile device -- Orthopedic Arthroscope.
Terminated		 HRXK012695
Sep 16, 2008ArthroCare Corporation
ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA - Sterile Surgical Device.
Terminated		 HRXK053567
Apr 10, 2008Myelotec, Inc.
Myelotec Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4 (Product Code: 2010). Myelotech, Roswell, GA 30076.
Terminated		 HRXK980734
Apr 10, 2008Myelotec, Inc.
Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
Terminated		 HRXK960194
Apr 2, 2008Stryker Endoscopy
Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
Terminated		 HRXK951267
Nov 2, 2006Hydrocision, Inc.
Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663
Terminated		 HRXK032529
Nov 2, 2006Hydrocision, Inc.
HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58662
Terminated		 HRXK032529
Jul 13, 2005Warsaw Orthopedic, Inc.
Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
Terminated		 HRXK993021
Jul 13, 2005Warsaw Orthopedic, Inc.
Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
Terminated		 HRXK993021
Jul 13, 2005Warsaw Orthopedic, Inc.
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
Terminated		 HRXK993021
May 3, 2005Stryker Endoscopy
Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
Terminated		 HRXNone listed
Oct 23, 2004Linvatec Corp.
Ultra Power Burs, Sterile, Single-Use.
Terminated		 HRXK781979
K981636
Jan 9, 2003Smith & Nephew, Inc.
Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile Catalog Number: 014725
Terminated		 HRXK931621

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