Panels › General, Plastic Surgery › Product code GES · Class 1
Blade, Scalpel
Regulation 878.4800
0510(k)s in 12 months (48 all time)
0recalls in 12 months (13 all time)
1recalls that name a 510(k)
Top companies in GES
| Company | 510(k)s | Recalls |
|---|---|---|
| Aeroceuticals | 4 | 0 |
| Becton Dickinson & Company | 0 | 4 |
| Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | 0 | 4 |
| Imm Enterprises , Ltd. | 3 | 0 |
| Medelec Intl. Corp. | 3 | 0 |
| American Safety Razor Co. | 2 | 0 |
| Keisei Medical Industrial Co., Ltd. | 2 | 0 |
| Lukens Corp. | 2 | 0 |
| Miltex, Inc. | 0 | 2 |
| Vxtra Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2022 | Southmedic, Inc. Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO Open, Classified |
GES | None listed |
| Sep 8, 2016 | Aspen Surgical Puerto Rico Corp. Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464."
Intended for tissue separation and other procedures t Terminated |
GES | None listed |
| Nov 5, 2012 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***"
Ophthalmic surgery Terminated |
GES | None listed |
| Nov 5, 2012 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***"
Ophthalmic surgery Terminated |
GES | None listed |
| Nov 5, 2012 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***"
Ophthalmic surgery Terminated |
GES | None listed |
| Nov 5, 2012 | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***"
Ophthalmic surgery Terminated |
GES | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No SMS210 Used for cutting tissue in surgical and laboratory procedures. Terminated |
GES | K923170 |
| Feb 20, 2009 | Miltex, Inc. Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades. Terminated |
GES | None listed |
| Oct 2, 2007 | Becton Dickinson & Company Shelf Pack:
Bard-Parker Rib-Back Stainless Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant con Terminated |
GES | None listed |
| Oct 2, 2007 | Becton Dickinson & Company Shelf Pack:
Bard-Parker Rib-Back Carbon Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant conta Terminated |
GES | None listed |
| Apr 21, 2007 | Miltex, Inc. Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels. Terminated |
GES | None listed |
| Nov 16, 2005 | Becton Dickinson & Company BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use Terminated |
GES | None listed |
| Aug 3, 2005 | Becton Dickinson & Company BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631. Terminated |
GES | None listed |
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