Panels › General, Plastic Surgery › Product code HRQ · Class 1
Hemostat
Regulation 878.4800
0510(k)s in 12 months (15 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in HRQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Scanlan Intl., Inc. | 3 | 0 |
| I M, Inc. | 2 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 2 |
| Aesculap Inc | 0 | 1 |
| Applied Medical Technologies | 1 | 0 |
| Disposable Sterile Surgical Instruments, Inc. | 1 | 0 |
| Falcon Instruments, Inc. | 1 | 0 |
| Far East Intl. Trading Corp. | 1 | 0 |
| Imm Enterprises , Ltd. | 1 | 0 |
| Kelleher Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2025 | Aesculap Inc Numerous models of nonsterile hemostatic forceps:
(1) REF BH100R, Carrel Artery Forceps 85MM;
(2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;
(3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;
(4) Open, Classified |
HRQ | None listed |
| Dec 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 Open, Classified |
HRQ | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion Hemostat kits labeled as:
a) STERILE CURV KELLY HEMOSTAT, Product Code 65340;
b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145;
c) STERILE STRT KELLY HEMOSTAT (SK8039), Prod Open, Classified |
HRQ | None listed |
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