System, Applicator, Radionuclide, Manual
Regulation 892.5650
0510(k)s in 12 months (36 all time)
0recalls in 12 months (11 all time)
1recalls that name a 510(k)
Top companies in IWJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2021 | Sirtex Medical Limited SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use. Terminated |
IWJ | None listed |
| Jan 10, 2020 | Riverpoint Medical, LLC Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR. Terminated |
IWJ | None listed |
| Oct 9, 2018 | Theragenics Corporation Theragenics Applicator Needle (18g x 20cm)
The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle Terminated |
IWJ | None listed |
| Jan 9, 2018 | Riverpoint Medical, LLC RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18
Product Usage:
The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the ne Terminated |
IWJ | None listed |
| Oct 12, 2011 | Worldwide Medical Technologies, LLC 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 Terminated |
IWJ | None listed |
| Jul 13, 2010 | Medical Device Technologies, Inc. Angiotech Prostate Stabilization Set.
Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty Dist. - 4,180.
MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Aven Terminated |
IWJ | K944522 |
| Oct 22, 2008 | Alpha Omega Services Inc Alpha-Omega Services, Inc. Product No:NFW0001-010
Description: FLEXIGUIDE NEEDLE, SERIES-15, 25 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG
Quantity: 10/PKG L-NFW0001 Terminated |
IWJ | None listed |
| Oct 22, 2008 | Alpha Omega Services Inc Alpha-Omega Services, Inc. Product No:NFW0001-009
Description: FLEXIGUIDE NEEDLE, SERIES-15, 20 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG
Quantity: 10/PKG L-NFW0001 Terminated |
IWJ | None listed |
| Oct 22, 2008 | Alpha Omega Services Inc Alpha-Omega Services, Inc. Product No: SPECIAL-NFV
Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L- Terminated |
IWJ | None listed |
| Oct 22, 2008 | Alpha Omega Services Inc Alpha-Omega Services, Inc. Product No: NFV0003-003
Description: NEEDLE, FLEXIGUIDE: SERIES-15, 20CM, WITH
FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG Terminated |
IWJ | None listed |
| Oct 22, 2008 | Alpha Omega Services Inc Alpha-Omega Services, Inc. Product No: NFV0001-004
Description: NEEDLE, FLEXIGUIDE: SERIES-15, 25CM, WITH
FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG Terminated |
IWJ | None listed |
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