Panels › General, Plastic Surgery › Product code GDF · Class 1
Guide, Needle, Surgical
Regulation 878.4800
0510(k)s in 12 months (28 all time)
0recalls in 12 months (20 all time)
5recalls that name a 510(k)
Top companies in GDF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2023 | Advance Medical Designs, Inc. procedural kits containing ultrasonic transmission gel, Item Numbers:
a) 28-GG023,
b) 28-GG105,
c) 28-GG107,
d) 28-GG121,
e) 28-GG219,
f) 28-GG223,
g) 28-GG303,
h) 28-GG307,
i) 28-GG519,
j) Open, Classified |
GDF | None listed |
| Sep 9, 2023 | Advance Medical Designs, Inc. Procedural kits containing ultrasonic transmission gel, Item Numbers:
a) 28-EG103,
b) 28-EG125,
c) 28-EG135,
d) 28-EG151,
e) 28-EG161,
f) 28-EG163,
g) 28-EG197 Open, Classified |
GDF | None listed |
| Aug 5, 2021 | M.D.L. S.r.l. Mammary Nodules Localization Terminated |
GDF | None listed |
| May 2, 2017 | Bard Peripheral Vascular Inc MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201
Product Usage:
The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire Terminated |
GDF | None listed |
| Sep 8, 2016 | Hologic, Inc SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece
Product Usage:
The Sure Sight Obturato Terminated |
GDF | None listed |
| Sep 8, 2016 | Hologic, Inc SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece) Terminated |
GDF | None listed |
| Mar 3, 2016 | Stryker Instruments Div. of Stryker Corporation 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. Terminated |
GDF | K904172 |
| Mar 3, 2016 | Stryker Instruments Div. of Stryker Corporation 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. Terminated |
GDF | K904172 |
| Mar 3, 2016 | Stryker Instruments Div. of Stryker Corporation (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. Terminated |
GDF | K904172 |
| Mar 3, 2016 | Stryker Instruments Div. of Stryker Corporation (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. Terminated |
GDF | K904172 |
| Sep 16, 2014 | Bard Peripheral Vascular Inc Bard DuaLok Breast Lesion Localization Wire,
Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm).
The Bard DuaLok Breast Lesion Terminated |
GDF | K935457 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N
Lot 123263
-SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279
-Suture Passing Wire. Ref. AR-1255 Terminated |
GDF | None listed |
| Jul 28, 2010 | Carefusion 2200 Inc Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Pa Terminated |
GDF | None listed |
| Jul 13, 2010 | Medical Device Technologies, Inc. Angiotech Needle Guide.
Needle Guide for Lorad Stereo Loc. STERILE. Product Number: LNGC14GX, LNGC1619PX, LNGC2022YX, LNGO1619PX, LNGO2022YX. 510k Exempt. Qty Dist. - 13,800.
MEDICAL DEVICE TEC Terminated |
GDF | None listed |
| Jul 24, 2007 | Synovis Surgical Inovation Div. of Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument.
Distributed by Aliez Medical Applicatio Terminated |
GDF | None listed |
| Jul 24, 2007 | Synovis Surgical Inovation Div. of Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DGPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 23 mm, 250 mm long, Terminated |
GDF | None listed |
| Jul 24, 2007 | Synovis Surgical Inovation Div. of Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating.
Distributed by Aliez Terminated |
GDF | None listed |
| Jul 24, 2007 | Synovis Surgical Inovation Div. of Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm, 250 mm long.
Terminated |
GDF | None listed |
| Jul 24, 2007 | Synovis Surgical Inovation Div. of Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalgo ref. 4-12GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm, 250 mm long.
D Terminated |
GDF | None listed |
| Jul 24, 2007 | Synovis Surgical Inovation Div. of Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-10GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 10 mm, 250 mm long.
Terminated |
GDF | None listed |
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