Worldwide Medical Technologies, LLC
Woodbury, CT, US
Worldwide Medical Technologies, LLC appears in FDA device records in Woodbury, CT. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Worldwide Medical Technologies, LLC between 1998 and 2007. The busiest year on record is 1998, with 7. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 7 |
| 1999 | 1 |
| 2002 | 3 |
| 2003 | 3 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062214 | BRACHYSCIENCES STRANDPORT | KXK | Substantially Equivalent | |
| K023179 | READI-STRAND, MODEL PSSTRAND | KXK | Substantially Equivalent | |
| K022705 | READI-STRAND, MODEL PSSTRAND | KXK | Substantially Equivalent | |
| K022389 | READI-LOAD SYSTEM, MODEL PSS 1820RL | KXK | Substantially Equivalent | |
| K020641 | SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 | BZD | Substantially Equivalent | |
| K020337 | READI-STRAND; MODEL PSSTRAND | KXK | Substantially Equivalent | |
| K020867 | BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL | KNW | Substantially Equivalent | |
| K991344 | WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS | KXK | Substantially Equivalent | |
| K981889 | WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE | FCG | Substantially Equivalent | |
| K982097 | WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD | FMI | Substantially Equivalent | |
| K981470 | WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE | IZH | Substantially Equivalent | |
| K980137 | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY | LRO | Substantially Equivalent | |
| K980068 | WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE | KNW | Substantially Equivalent | |
| K974794 | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K974118 | WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET | IWJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0040-2012 | Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate | Length of the cannula hub is longer and may not permit a fit with the Applicator | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain