Panels › General, Plastic Surgery › Product code GDZ · Class 1
Handle, Scalpel
Regulation 878.4800
0510(k)s in 12 months (16 all time)
0recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in GDZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ansell Sandel Medical Industries LLC | 0 | 7 |
| The Huxley Instrument Corp. | 2 | 0 |
| Artiberia | 1 | 0 |
| Bard Access Systems | 0 | 1 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Brimfield Scientific Instruments | 1 | 0 |
| Instrument Makar, Inc. | 1 | 0 |
| Integra York PA, Inc | 0 | 1 |
| Keisei Medical Industrial Co., Ltd. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M Open, Classified |
GDZ | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion scalpel handle kits labeled as:
a) STERILE # 3 SCALPEL HANDLE, Product Code 66825;
b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290 Open, Classified |
GDZ | None listed |
| Oct 12, 2022 | Steris Corporation Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 Terminated |
GDZ | None listed |
| Oct 16, 2017 | Teleflex Medical Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted i Completed |
GDZ | None listed |
| May 31, 2016 | Integra York PA, Inc Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument. Terminated |
GDZ | None listed |
| Apr 14, 2015 | Bard Access Systems Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels. Terminated |
GDZ | None listed |
| Jan 8, 2014 | Ansell Sandel Medical Industries LLC Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade
Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA
Em Terminated |
GDZ | None listed |
| Jan 8, 2014 | Ansell Sandel Medical Industries LLC Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade
Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 U Terminated |
GDZ | None listed |
| Jan 8, 2014 | Ansell Sandel Medical Industries LLC Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade
Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA
Em Terminated |
GDZ | None listed |
| Jan 8, 2014 | Ansell Sandel Medical Industries LLC Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade
Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA
Em Terminated |
GDZ | None listed |
| Jan 8, 2014 | Ansell Sandel Medical Industries LLC Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade
Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 U Terminated |
GDZ | None listed |
| Jan 8, 2014 | Ansell Sandel Medical Industries LLC Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade
Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA
Em Terminated |
GDZ | None listed |
| Jan 8, 2014 | Ansell Sandel Medical Industries LLC Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade
Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA
Em Terminated |
GDZ | None listed |
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