510(k) K003541 ยท GEX Powered Laser Surgical Instrument
DENLASER, MODEL 800
| Applicant | CAO Group, Inc., Sandy UT, US |
| Decision | Substantially Equivalent, Jan 25, 2001 |
| Received | Nov 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003541
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Jan 4, 2008 | Siemens Medical Solutions USA Inc Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
| Nov 29, 2007 | Siemens Medical Solutions USA Inc Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534 Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.