Panels › General, Plastic Surgery › Product code GDJ · Class 1
Clamp, Surgical, General & Plastic Surgery
Regulation 878.4800
0510(k)s in 12 months (32 all time)
0recalls in 12 months (9 all time)
1recalls that name a 510(k)
Top companies in GDJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Edward Weck, Inc. | 5 | 0 |
| Integra LifeSciences Corp. | 0 | 4 |
| Conphar, Inc. | 2 | 0 |
| Med General | 2 | 0 |
| Medtronic Perfusion Systems | 0 | 2 |
| United States Surgical, A Division of Tyco Healthc | 2 | 0 |
| Applied Medical Technologies | 1 | 0 |
| Artiberia | 1 | 0 |
| Berkeley Bio-Medical, Inc. | 1 | 0 |
| Berkeley Medevices | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630;
2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general Open, Classified |
GDJ | None listed |
| Jul 23, 2024 | Medtronic Perfusion Systems TourniKwik Tourniquet Set (CFN 79012) Open, Classified |
GDJ | K855144 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Tourniquet Sets:
a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004,
b) DLP 7 in (17.8 cm) Tourniquet Kit, Model Number 79009 Open, Classified |
GDJ | None listed |
| Jun 29, 2018 | Integra LifeSciences Corp. MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R
The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures Terminated |
GDJ | None listed |
| Jun 29, 2018 | Integra LifeSciences Corp. MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A
The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedur Terminated |
GDJ | None listed |
| Jun 29, 2018 | Integra LifeSciences Corp. MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E
The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures Terminated |
GDJ | None listed |
| Jun 29, 2018 | Integra LifeSciences Corp. MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079
The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a ri Terminated |
GDJ | None listed |
| Aug 29, 2013 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to Terminated |
GDJ | None listed |
| Jul 7, 2005 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew Grasper, Cupped 3.4mm
REF: 011014 Terminated |
GDJ | None listed |
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