510(k) K012605 ยท HRX Arthroscope
REPROCESSED ATHROSCOPICS BURS
| Applicant | Alliance Medical Corp., Phoenix AZ, US |
| Decision | Substantially Equivalent, Nov 7, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.