Panels › General, Plastic Surgery › Product code GDI · Class 1
Dissector, Surgical, General & Plastic Surgery
Regulation 878.4800
0510(k)s in 12 months (7 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in GDI
| Company | 510(k)s | Recalls |
|---|---|---|
| Progressive Medical Inc | 0 | 2 |
| Beecher Medical Diagnostic Instrumentation | 1 | 0 |
| Carwild Corp. | 1 | 0 |
| Edward Weck, Inc. | 1 | 0 |
| Ethicon Endo-Surgery Inc | 0 | 1 |
| EXP Pharmaceutical Services Corp | 0 | 1 |
| Galenica Enterprises, Inc. | 1 | 0 |
| He, Inc | 0 | 1 |
| Kelleher Corp. | 1 | 0 |
| Ormed Mfg., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 2444;
EXP (repackager), Covidien (OEM)
Specimen retriever bag. Terminated |
GDI | None listed |
| Nov 9, 2012 | Progressive Medical Inc Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/ Terminated |
GDI | None listed |
| Oct 26, 2012 | Progressive Medical Inc Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/ Terminated |
GDI | None listed |
| Aug 27, 2010 | He, Inc V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various Terminated |
GDI | None listed |
| Jan 13, 2009 | Sterilmed Inc Lap Instruments/Graspers/Forceps - COLD
Model #'s:
AUT173030
AUT174233
AUT174317
AUT176613
AUT176647
AUTECATCH10G and
ETH5DSG
A manual surgical instrument for general use is a nonpowered, hand-held, Terminated |
GDI | None listed |
| Jan 29, 2008 | Ethicon Endo-Surgery Inc Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242 Terminated |
GDI | K984240 |
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