Panels › General, Plastic Surgery › Product code GDY · Class 1
Gauze/Sponge, Internal, X-Ray Detectable
Regulation 878.4450
0510(k)s in 12 months (111 all time)
1recalls in 12 months (66 all time)
53recalls that name a 510(k)
Top companies in GDY
| Company | 510(k)s | Recalls |
|---|---|---|
| American Surgical Company | 0 | 36 |
| Lorrex Health Products | 9 | 0 |
| Argon Medical Devices, Inc | 0 | 7 |
| Medical Perspectives Corp. | 7 | 0 |
| Thantex Specialties, Inc. | 7 | 0 |
| Ultracell Medical Technologies, Inc. | 7 | 0 |
| Mcneil Healthcare, Inc. | 5 | 0 |
| Medical Action Industries, Inc. | 1 | 4 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 5 |
| Carefree Surgical Specialties | 0 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 3"
Ref Number: 20-07S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 1/2"
Ref Number: 20-04S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/4" x 1/4"
Ref Number: 20-01S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Nov 18, 2015 | Rainbow Specialty & Health Products Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil Terminated |
GDY | None listed |
| Nov 18, 2015 | Rainbow Specialty & Health Products Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol Terminated |
GDY | None listed |
| May 10, 2012 | International Medsurg Connection, Inc. 8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China Terminated |
GDY | None listed |
| May 10, 2012 | International Medsurg Connection, Inc. 8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; ite Terminated |
GDY | None listed |
| Jun 2, 2010 | Argon Medical Devices, Inc ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751. Terminated |
GDY | K780871 |
| Jun 2, 2010 | Argon Medical Devices, Inc ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO. 194284 Labeled Sterile, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669. Terminated |
GDY | K780871 |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the app Terminated |
GDY | K955599 |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker Instruments, Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary canal prior t Terminated |
GDY | K955599 |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10, Stryker Instruments, Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary can Terminated |
GDY | K955599 |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 206-730, Rx, Sterile, Stryker Instruments Kalamazoo, MI.
The femoral sponge is an absorbent that is used to d Terminated |
GDY | K955599 |
| Mar 15, 2010 | Stryker Instruments Div. of Stryker Corporation Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo, MI.
The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone c Terminated |
GDY | K955599 |
| Sep 20, 2008 | Medline Industries Inc Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 6 Terminated |
GDY | K061316 |
| Apr 27, 2005 | Staar Surgical Co Inc STAAR Phaco Tubing Kit Terminated |
GDY | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.