Panels › General, Plastic Surgery › Product code PXP · Class 1
Breast Biopsy / Localization Tray
Regulation 878.4800
0510(k)s in 12 months (0 all time)
0recalls in 12 months (8 all time)
0recalls that name a 510(k)
Top companies in PXP
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 6 |
| Centurion Medical Products Corporation | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ;
2) BREAST BIOPSY TRAY, Pack Number MNS5070;
3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A;
4) BREAST Open, Classified |
PXP | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) CIRCUMCISION TRAY, Pack Number CIT6715;
2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920;
3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095;
4) RE Open, Classified |
PXP | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure kits, labeled as:
1) BREAST BIOPSY KIT, Pack Number MNS6950A;
2) BREAST BIOPSY PACK, Pack number BT515A Open, Classified |
PXP | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion Kits, trays, and packs labeled as follows:
BREAST BIOPSY KIT, REF MNS4360 Open, Classified |
PXP | None listed |
| Aug 3, 2023 | MEDLINE INDUSTRIES, LP - Northfield Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a. BREAST BIOPSY KIT, Model Number: DYNDA1224A, DYNDA1224B;
b. BREAST BIOPSY TRAY, Mo Open, Classified |
PXP | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
BREAST BIOPSY TRAY, Model Number SPEC0130C Open, Classified |
PXP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
P151659 BIOPSY TRAY
P243133 LATEX TUBING PACK
P243133 LATEX TUBING PACK
P243133 LATEX TUBING PACK
P261569 PACK BIOPSY
P392929 BMT-LACERATION PACK
P429589A TRAY BONE MARRO ASC LTX SAFE
P734 Terminated |
PXP | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-
SPEC0002B ARTHROGRAM TRAY
SPEC0002B ARTHROGRAM TRAY
SPEC0004C ARTHROGRAM TRAY
SPEC0071B CUSTOM BX TRAY
SPEC0076G STEREO BIOPSY PACK-LF
SPEC0122 BASIC BIOPSY TRAY
SPEC0130B BREAST BIOPSY TRA Terminated |
PXP | None listed |
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