Panels › Cardiovascular › Product code OFG · Class 2
Ct Biopsy Tray
Regulation 870.4075
0510(k)s in 12 months (0 all time)
12recalls in 12 months (26 all time)
0recalls that name a 510(k)
Top companies in OFG
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 14 |
| Medline Industries, LP | 0 | 12 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D Open, Classified |
OFG | None listed |
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068;
2) BREAST BIOPSY PACK, Model Number: PHS234706I Open, Classified |
OFG | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as:
BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302 Open, Classified |
OFG | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
BREAST-HERNIA-PORT CDS-LF
CDS984853L Open, Classified |
OFG | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A;
2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A;
3) CT BIOPSY TRAY, Model Number:DYNDH1143C;
4) BIOPSY Open, Classified |
OFG | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B;
2. RR-DR. CHHETRI MDL PACK, Medline Kit Numb Open, Classified |
OFG | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
BIOPSY PACK DYNJ38587A, DYNJ38587B
BIOPSY/DRAINAGE TRAY-LF DYNJ30078D
W LINQ PACK DYNJ59108B Open, Classified |
OFG | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A Open, Classified |
OFG | None listed |
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B Open, Classified |
OFG | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A;
2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A;
3) CT BIOPSY TRAY, Model Number: DYNDH1143C;
4) BIO Open, Classified |
OFG | None listed |
| Jan 28, 2026 | Medline Industries, LP Medline medical procedure convenience kits labeled as:
1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L;
2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B;
3) DERMATOLOGY PACK, Kit SKU DYNJT3658A. Open, Classified |
OFG | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C;
2) BIOPSY BREAST PACK, REF DYNJ65361A;
3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A. Open, Classified |
OFG | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A;
2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B;
3) BILAT TESTICULAR SPERM EXTRACT, Mod Open, Classified |
OFG | None listed |
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) CT BIOPSY PACK, Pack Number DYNJ62734A;
2) E R C P PACK, Pack Number DYNJ44115A;
3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A Open, Classified |
OFG | None listed |
| Dec 30, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline custom medical procedure kits labeled as:
1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476;
2) DIEP FLAP, REF DYNJ910120 Open, Classified |
OFG | None listed |
| Dec 20, 2024 | MEDLINE INDUSTRIES, LP - Northfield DIEP FLAP Convenience kit, SKU DYNJ910120.
Convenience kits used for various procedures. Open, Classified |
OFG | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C;
2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G;
3) TREATMENT ROOM PACK, REF DYNJ41473G;
4) TREATMENT ROOM PACK, REF D Open, Classified |
OFG | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline brand medical procedure convenience kits, labeled as:
a) CONE BIOPSY PACK, REF DYNJ17534L;
b) BIOPSY TRAY, REF DYNJ43076A;
c) LOU LOOP RECORDER PACK, REF DYNJ49404C;
d) CT BIOPSY, REF DYN Open, Classified |
OFG | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J;
2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ;
3) BIOPSY DRAPE PACK , Pack Number 00-400762H ;
4) BIOPS Open, Classified |
OFG | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedural kits labeled as:
1) BIOPSY PACK, Pack Number DYNJ63370A;
2) CIRCUMCISION TRAY, Pack Number CIT7210;
3) CIRCUMCISION TRAY, Pack Number DYNDA2271;
4) MERCY MEDICAL CIRCUMCISION T Open, Classified |
OFG | None listed |
| Aug 27, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure packs containing Shenli syringes, labeled as follows:
1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260;
2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045 Open, Classified |
OFG | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Kits, trays, and packs labeled as follows:
a) Description, REF DYNDH1679;
b) BREAST BIOPSY TRAY, REF DYNDH1664;
c) BREAST BIOPSY TRAY, REF DYNDH1431A;
d) BREAST BIOPSY TRAY, REF DYNJ46448 Open, Classified |
OFG | 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. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B;
b. BASIC BIOPSY TRAY, Model Numb Open, Classified |
OFG | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B;
b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C;
c) BIOPSY PACK, Open, Classified |
OFG | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B Open, Classified |
OFG | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield Sterile Procedural Trays, labeled as the following:
a. BREAST BIOPSY PACK-LF
b. BREAST BIOPSY PACK
c. LAPAROTOMY PACK
d. BREAST PACK
e. SOFT TISSUE PACK
f. HEMORRHOID PACK
g. RECTAL
h. BREAST
i. BREA Open, Classified |
OFG | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.