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)
Top companies in HRX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2025 | MEDLINE 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 |
HRX | K203526 |
| Nov 25, 2024 | Karl 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 |
HRX | K030009 |
| Sep 6, 2024 | MEDLINE 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 |
HRX | K203526 |
| Jul 1, 2024 | WOM 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 |
HRX | K062380 |
| May 17, 2021 | ADRIA SRL Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749 Terminated |
HRX | K141557 |
| May 17, 2021 | ADRIA SRL Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745 Terminated |
HRX | K141557 |
| May 17, 2021 | ADRIA SRL Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715 Terminated |
HRX | K141557 |
| Jan 19, 2021 | ReNovo, 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 |
HRX | None listed |
| Jul 24, 2020 | Smith & 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 |
HRX | K925573 |
| Apr 24, 2020 | Medtronic 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 |
HRX | K010246 K041454 +1 |
| Apr 24, 2020 | Medtronic 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 |
HRX | K010246 K041454 +1 |
| Apr 24, 2020 | Medtronic 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 |
HRX | K010246 K041454 +1 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jul 25, 2019 | Stryker 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 |
HRX | K940230 |
| Jun 26, 2019 | MicroAire Surgical Instruments, LLC SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 Terminated |
HRX | K912871 |
| Apr 30, 2019 | Stryker GmbH Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1 Terminated |
HRX | K922391 |
| Apr 30, 2019 | Stryker GmbH Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 Terminated |
HRX | K922391 |
| Jul 27, 2018 | Stryker 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 |
HRX | K012605 |
| May 25, 2018 | MicroAire 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 |
HRX | K912871 |
| Nov 9, 2017 | Stryker 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 |
HRX | K130430 |
| Jul 24, 2017 | Richard 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 |
HRX | K953868 |
| Mar 2, 2017 | Myelotec, Inc. Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels Open, Classified |
HRX | K980734 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Arthroscope. Terminated |
HRX | K920800 |
| May 10, 2016 | Medical 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 |
HRX | K093409 |
| Feb 9, 2016 | Richard 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 |
HRX | K984304 |
| Feb 9, 2016 | Richard 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 |
HRX | K984304 |
| Feb 9, 2016 | Richard 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 |
HRX | K984304 |
| Jan 15, 2016 | DePuy 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 |
HRX | K954465 |
| Jan 15, 2016 | DePuy 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 |
HRX | K041824 |
| Jan 15, 2016 | DePuy 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 |
HRX | K041824 |
| Dec 22, 2015 | Instratek, Incorporated Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System. Terminated |
HRX | None listed |
| Sep 3, 2015 | Customed, 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 |
HRX | None listed |
| Sep 3, 2015 | Customed, 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 |
HRX | None listed |
| Sep 3, 2015 | Customed, 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 |
HRX | None listed |
| Sep 3, 2015 | Customed, 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 |
HRX | K971920 |
| Sep 3, 2015 | Customed, 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 |
HRX | None listed |
| Sep 3, 2015 | Customed, 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 |
HRX | K904694 |
| Sep 3, 2015 | Customed, 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 |
HRX | K904694 |
| Sep 3, 2015 | Customed, 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 |
HRX | None listed |
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