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) |
|---|---|---|---|
| Jul 10, 2026 | Argon Medical Devices, Inc Arterial Line Kit 20ga x 6, REF: 400115A Open, Classified |
GDY | K780871 |
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Model/Catalog Number: 15506/25
Product Des Open, Classified |
GDY | K882708 |
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS
Model/Catalog Number: 15505/25
Product Description: Roboti Open, Classified |
GDY | K882708 |
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS
Model/Catalog Number: 15505/25
Product Description: Roboti Open, Classified |
GDY | K882708 |
| Aug 8, 2025 | Carefree Surgical Specialties Brand Name: Carefree Surgical Specialties
Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Model/Catalog Number: 15508/25
Product Description: Ro Open, Classified |
GDY | K882708 |
| Mar 21, 2024 | Covidien Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 Open, Classified |
GDY | None listed |
| Jan 24, 2022 | Argon Medical Devices, Inc 1. Arterial Line Kit 20ga x 6"
2. Arterial Line Kit /1 20ga x 6" Open, Classified |
GDY | K780871 |
| Aug 11, 2021 | Cypress Medical Products LLC McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile
McKesson Part # 16-2112121 Terminated |
GDY | None listed |
| Apr 8, 2020 | Argon Medical Devices, Inc PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percut Terminated |
GDY | K780126 |
| Apr 8, 2020 | Argon Medical Devices, Inc Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressur Terminated |
GDY | K780871 |
| Apr 8, 2020 | Argon Medical Devices, Inc Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressu Terminated |
GDY | K780871 |
| Mar 1, 2019 | Medical Action Industries Inc Laparotomy Sponge with the following product description and model numbers:
1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300;
2. Lap 18X18 XR (5 each/pack, 40 Terminated |
GDY | None listed |
| Nov 27, 2018 | Medical Action Industries Inc Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap.
intended use: Lapar Terminated |
GDY | None listed |
| Oct 12, 2017 | Covidien LLC Situate Gauze RF and X-Ray detectable.
Product Number: G0804-16P02CN-1
Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable hav Terminated |
GDY | None listed |
| Jul 17, 2017 | Covidien LP Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge.
product Usage:
Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally Terminated |
GDY | None listed |
| Apr 19, 2017 | Medical Action Industries Inc Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs).
Intended for packing and absorption externally or within patient wounds in various procedures or su Open, Classified |
GDY | None listed |
| Apr 19, 2017 | Medical Action Industries Inc White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs.
Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. Open, Classified |
GDY | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Non-Strung 3/4"
Ref Number: 31-03
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1/8"
Ref Number: 30-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1.25"
Ref Number: 30-05
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1"
Ref Number: 30-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 3/4"
Ref Number: 30-03
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1/2"
Ref Number: 30-02
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 3/8"
Ref Number: 30-01
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Strung 1/4"
Ref Number: 30-00
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 70 mm x 10090 mm
Ref Number: 23-24
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 30 mm x 90 mm (Glassine)
Ref Number: 23-15G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854713 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 15 mm x 15 mm (Glassine)
Ref Number: 23-12G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 30 mm x 70 mm (Glassine)
Ref Number: 23-10G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 30 mm x 70 mm
Ref Number: 23-10
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 20 mm x 60 mm (Glassine)
Ref Number: 23-09G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 20 mm x 60 mm
Ref Number: 23-09
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 13 mm x 60 mm (Glassine)
Ref Number: 23-08G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 13 mm x 60 mm
Ref Number: 23-08
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 9 mm x 50 mm (Glassine)
Ref Number: 23-07G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 6 mm x 50 mm
Ref Number: 23-06
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 15 mm x 20 mm (Glassine)
Ref Number: 23-04G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 15 mm x 20 mm
Ref Number: 23-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 10 mm x 13 mm (Glassine)
Ref Number: 23-03G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 5 mm x 13 mm (Glassine)
Ref Number: 23-02G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 5 mm x 8 mm (Glassine)
Ref Number: 23-01G
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Ultracot 5 mm x 8 mm
Ref Number: 23-01
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/2" x 2"
Ref Number: 20-32S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot White 1.5 cm x 5.5 cm
Ref Number: 20-31SW
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/4" x 1.5"
Ref Number: 20-30S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 3/8" x 2"
Ref Number: 20-26S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 3/8" x 3/8"
Ref Number: 20-22S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1/8" x 1/8"
Ref Number: 20-19S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 3/8" x 3/4"
Ref Number: 20-14S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Americot Blue 1" x 3"
Ref Number: 20-10S
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
GDY | K854714 |
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