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

DateFirm and productCodeLinked 510(k)
Mar 25, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
Open, Classified
HRXK203526
Nov 25, 2024Karl Storz Endoscopy
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm R
Open, Classified
HRXK030009
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702
Open, Classified
HRXK203526
Jul 1, 2024WOM World Of Medicine AG
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
Open, Classified
HRXK062380
May 17, 2021ADRIA SRL
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Terminated
HRXK141557
May 17, 2021ADRIA SRL
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Terminated
HRXK141557
May 17, 2021ADRIA SRL
Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
Terminated
HRXK141557
Jan 19, 2021ReNovo, Inc.
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reproce
Open, Classified
HRXNone listed
Jul 24, 2020Smith & Nephew, Inc.
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
Open, Classified
HRXK925573
Apr 24, 2020Medtronic Sofamor Danek USA Inc
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessar
Terminated
HRXK010246
K041454 +1
Apr 24, 2020Medtronic Sofamor Danek USA Inc
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessar
Terminated
HRXK010246
K041454 +1
Apr 24, 2020Medtronic Sofamor Danek USA Inc
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the neces
Terminated
HRXK010246
K041454 +1
Jul 25, 2019Stryker GmbH
Endintrak 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic planta
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic p
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chron
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plan
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciit
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fa
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic planta
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fa
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasci
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar f
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasci
Terminated
HRXK940230
Jul 25, 2019Stryker GmbH
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciit
Terminated
HRXK940230
Jun 26, 2019MicroAire Surgical Instruments, LLC
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Terminated
HRXK912871
Apr 30, 2019Stryker GmbH
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Terminated
HRXK922391
Apr 30, 2019Stryker GmbH
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Terminated
HRXK922391
Jul 27, 2018Stryker Sustainability Solutions
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in
Terminated
HRXK012605
May 25, 2018MicroAire Surgical Instruments, LLC
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed w
Terminated
HRXK912871
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
Terminated
HRXK130430
Jul 24, 2017Richard Wolf GmbH
Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard p
Open, Classified
HRXK953868
Mar 2, 2017Myelotec, Inc.
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Open, Classified
HRXK980734
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Arthroscope.
Terminated
HRXK920800
May 10, 2016Medical Vision Ab
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
Terminated
HRXK093409
Feb 9, 2016Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut har
Terminated
HRXK984304
Feb 9, 2016Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut har
Terminated
HRXK984304
Feb 9, 2016Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone
Terminated
HRXK984304
Jan 15, 2016DePuy Mitek, Inc., a Johnson & Johnson Co.
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Terminated
HRXK954465
Jan 15, 2016DePuy Mitek, Inc., a Johnson & Johnson Co.
FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Terminated
HRXK041824
Jan 15, 2016DePuy Mitek, Inc., a Johnson & Johnson Co.
FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Terminated
HRXK041824
Dec 22, 2015Instratek, Incorporated
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Terminated
HRXNone listed
Sep 3, 2015Customed, Inc
ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXNone listed
Sep 3, 2015Customed, Inc
ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXNone listed
Sep 3, 2015Customed, Inc
ARTHROSCOPY PACK 3/Cs Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXNone listed
Sep 3, 2015Customed, Inc
GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXK971920
Sep 3, 2015Customed, Inc
EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXNone listed
Sep 3, 2015Customed, Inc
FEMORAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXK904694
Sep 3, 2015Customed, Inc
KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXK904694
Sep 3, 2015Customed, Inc
PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Terminated
HRXNone listed

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