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) |
|---|---|---|---|
| Sep 3, 2015 | Customed, Inc ARTHROSCOPY PK CS/4
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 |
| Jun 25, 2014 | Stryker Endoscopy Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver. Terminated |
HRX | K941333 |
| Jun 25, 2014 | The Anspach Effort, Inc. ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only***
This device is intended to be used with Anspach Systems Terminated |
HRX | K820777 |
| Nov 8, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek FMS Outflow Tubing with One-Way valve
Product Code:284649
Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath du Terminated |
HRX | K002040 K954465 |
| Nov 8, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek FMS Intermediary Tubing with One-Way valve
Product Code: 281142
Product Usage:
The Intermediary Tubing for FMS Fluid Management Systems connects the Inflow Tubing to the arthroscopic she Terminated |
HRX | K951843 |
| Nov 1, 2013 | Stryker Instruments Div. of Stryker Corporation Dekompressor Percutaneous Discectomy Probe.
The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebr Terminated |
HRX | K032473 |
| Jul 10, 2013 | Linvatec Corp. dba ConMed Linvatec ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set.
Intended for use for joint irrigation and dissention during arthroscopic procedures. Terminated |
HRX | K961590 |
| Jul 10, 2013 | Linvatec Corp. dba ConMed Linvatec ***REF C7120***APEX Arthroscopy Tubing Set.
Intended for use for joint irrigation and dissention during arthroscopic procedures. Terminated |
HRX | K954440 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270
- AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665
- AcromioBlaster Burr (Sage Green) 4.0mm Ref Terminated |
HRX | K012667 |
| Apr 1, 2013 | Zimmer, Inc. Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090, N1830R80-080, N1830R80-070, N1830R80-060, N1830R50-100, N1830R50-090, N Terminated |
HRX | K053267 K061345 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT#: 9297A***LINVATEC***Arthroscopic Blade***4.8mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland Terminated |
HRX | K012613 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot num Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-941-000***STRYKER***Arthroscopic Bur***4.0mm BARREL BUR***Hollow 6 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot numbe Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-532-000***STRYKER***Arthroscopic Blade***3.5mm RESECTOR***Hub Style - Formula***Yellow/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, F Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 275-534-000***STRYKER***Arthroscopic Blade***3.5mm AGGRESSIVE PLUS***Yellow/Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakel Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 375-545-000***STRYKER***Arthroscopic Blade***4.0mm TOMCAT CUTTER***Hub Style - Formula***Red/White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 275-941-000***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR Hollow 6 Flute***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 275-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 195024***Expir Terminated |
HRX | K012605 K012635 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205345***DYONICS***Arthroscopic Blade***4.5mm INCISOR PLUS, 13cm long***Fits Power/EP-1 Motor Drives***Violet***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205330***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm STONECUTTER, 13cm long***Fits Power/EP-1 Motor Drives***Maroon***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205326***DYONICS***Arthroscopic Burr, Wide Mouth***4.0mm ACROMIONIZER, 13cm long***Fits Power/EP-1 Motor Drives***Mauve***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205316***DYONICS***Arthroscopic Blade***4.5mm TURBOWHISKER, 13cm long***Fits Power/EP-1 Motor Drives***Navy Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTI Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205314***DYONICS***Arthroscopic Blade***5.5mm INCISOR, 13cm long***Fits Power/EP-1 Motor Drives***Mocha***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lak Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205310***DYONICS***Arthroscopic Blade***4.5mm SYNOVATOR, 13cm long***Fits Power/EP-1 Motor Drives***Forest Green***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTI Terminated |
HRX | K012611 K012652 |
| Feb 3, 2012 | Ascent Healthcare Solutions ***CAT 7205305***DYONICS***Arthroscopic Blade***3.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Beige***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS** Terminated |
HRX | K012611 K012652 |
| Sep 9, 2011 | Medtronic Spine LLC (formerly Kyphon Inc.) Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as K Terminated |
HRX | K011811 K041454 |
| Apr 8, 2011 | Stryker Endoscopy Inflow/Outflow Cannula;
Qty: 1;
distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
The inflow/outflow cannula is intended as a general purpose, concomitant suction and irrigatio Terminated |
HRX | K944210 |
| Mar 28, 2011 | Stryker Instruments Division of Stryker Corporation Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI.
The DeKompressor Percutaneous Discectomy Probe is intended for use in t Terminated |
HRX | K032473 |
| Mar 28, 2011 | Stryker Instruments Division of Stryker Corporation Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker Instruments, Kalamazoo, MI.
The DeKompressor Percutaneous Discectomy Probe is intended for use in th Terminated |
HRX | K032473 |
| Mar 7, 2011 | Biomet, Inc. Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE Terminated |
HRX | K072879 |
| Mar 7, 2011 | Biomet, Inc. Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE Terminated |
HRX | K072879 |
| Dec 28, 2010 | Stryker Endoscopy Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0078-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, SERRATED, STRAIGHT, 2-SIDED, ROUND, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0077-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, SERRATED, STRAIGHT, 2-SIDED, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic su Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0076-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, CRESCENT, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery wher Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0075-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, MINI-MENISCUS, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0074-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, ROSETTE, SERRATED, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic sur Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0073-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, RETRO, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery where a Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0072-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, HOOK, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery where a Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0071-113, 3mm ARTHRO-KNIFE SHEATHED KNIFE, BANANA, SERRATED LEFT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery w Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0071-103, 3mm, ARTHRO-KNIFE SHEATHED KNIFE, BANANA, SERRATED STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthopaedic surg Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF C4000 INTEQ TFCC SMALL JOINT SUTURING SYSTEM KITS, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF, 9973, 2.4mm ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for proper tissue dissection in small join Terminated |
HRX | None listed |
| Aug 9, 2010 | Linvatec Corp. dba ConMed Linvatec REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System.
CONMED LINVATEC, Terminated |
HRX | None listed |
| Oct 1, 2009 | Linvatec Corp. dba ConMed Linvatec Mpower PRO6200 Single Trigger Modular Handpiece,
Mpower PRO6202 Battery Two-Trigger Modular Handpiece,
Mpower PRO6300 Battery Oscillating Saw,
Mpower PRO6400 Battery Reciprocating Saw, and
Mpowe Terminated |
HRX | K981269 |
| Oct 1, 2009 | Linvatec Corp. dba ConMed Linvatec PowerProMax PRO5100M Battery Single Trigger,
PowerProMax PRO5200M Battery Two Trigger,
PowerProMax PRO5250M Battery Two-Trigger Standard,
PowerProMax PRO5300M Battery Oscillator,
PowerProMax PRO54 Terminated |
HRX | K981269 |
| Oct 1, 2009 | Linvatec Corp. dba ConMed Linvatec PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm,
PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm,
PRO5250, Power Terminated |
HRX | K981269 |
| Sep 21, 2009 | Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction
Catalog Number: 7211006 Terminated |
HRX | K051326 |
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