Panels › General, Plastic Surgery › Product code FSH · Class 1
Tray, Surgical, Needle
Regulation 878.4800
0510(k)s in 12 months (8 all time)
1recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in FSH
| Company | 510(k)s | Recalls |
|---|---|---|
| Carefusion 2200 Inc | 0 | 5 |
| American Pharmaseal Div. Ahsc | 3 | 0 |
| Carl Zeiss, Inc. | 2 | 0 |
| Applied Medical Research | 1 | 0 |
| Bard Access Systems, Inc. | 0 | 1 |
| Diagnostic Products Corp. | 1 | 0 |
| Emerson-Sack-Warner Corp. | 1 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. 4380 ECONOMY SOFT TISSUE BIOPSY TRAY
UDI-DI Code: 0110885403108563
4382A SOFT TISSUE BIOPSY TRAY
UDI-DI Code: 0110885403108501
The Soft Tissue Biopsy devices are indicated for use in the collection Open, Classified |
FSH | K813338 |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023 Open, Classified |
FSH | None listed |
| Feb 23, 2017 | Carefusion 2200 Inc Thoracentesis/ Paracentesis Kit 10/CS; STERILE; Terminated |
FSH | None listed |
| Feb 23, 2017 | Carefusion 2200 Inc JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE; Terminated |
FSH | K913306 |
| Feb 23, 2017 | Carefusion 2200 Inc JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE; Terminated |
FSH | K913306 |
| Feb 23, 2017 | Carefusion 2200 Inc ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE; Terminated |
FSH | K913306 K930217 |
| Feb 23, 2017 | Carefusion 2200 Inc JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE; Terminated |
FSH | K813338 |
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