Panels › Gastroenterology, Urology › Product code PPB · Class 2
Foley Catheter Kit (Excludes Hiv Testing)
Regulation 876.5130
0510(k)s in 12 months (0 all time)
3recalls in 12 months (14 all time)
0recalls that name a 510(k)
Top companies in PPB
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 11 |
| Medline Industries, LP | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B;
2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721 Open, Classified |
PPB | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M;
2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B;
3. Open, Classified |
PPB | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B;
2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721 Open, Classified |
PPB | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) T&A ENDO PACK, Model Number: DYNJ59620A;
2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S Open, Classified |
PPB | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) CV NEONATAL PACK, Pack Number DYNJ67356 Open, Classified |
PPB | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
1) PANENDOSCOPY-LF, REF DYNJ36728C;
2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A;
3) ENDO SINUS PACK, REF DYNJ66449. Open, Classified |
PPB | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S;
b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS;
c) TRAY FOLEY LTX 16FR 10ML U Open, Classified |
PPB | None listed |
| Sep 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline convenience kits containing semi-rigid suction liners labeled as follows:
a) ENDO KIT, Pack Number DYKE1350D;
b) ENDO KIT, Pack Number DYKE1514B Open, Classified |
PPB | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) GB GENERAL ENDO , Pack Number CDS984155G ;
2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B;
3) ENDO KIT, Pack Number DYKE1487C;
4) BRONCH ENDO W/O BED Open, Classified |
PPB | None listed |
| Aug 22, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits labeled as follows:
a) ENDO KIT, REF DYKE1410A Open, Classified |
PPB | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows:
a) ENDO KIT, REF DYKE1350D;
b) PANENDOSCOPY-LF, REF DYNJ36728C;
c) UMBILICAL VESSEL INSERTION, REF UVT1170;
d) UMBILICAL VESSEL INSERTION, R Open, Classified |
PPB | 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. CVC PACK, Model Number: DYNJ46967F;
b. ENDOVENOUS ABLATION PACK, Model Number: DYN Open, Classified |
PPB | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) CVC PACK, Model Number DYNJ46967F;
b) ENDOVENOUS CORE PACK, Model Number DYNJ62557;
c) ENSEMBLE CATHETER Open, Classified |
PPB | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. ENDOSCOPY-LF
b. SEPTO/ENDO Open, Classified |
PPB | None listed |
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