ClearanceBrief
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)
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Top companies in OFG

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
Open, Classified
OFGNone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
Open, Classified
OFGNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
Open, Classified
OFGNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
Open, Classified
OFGNone listed
May 7, 2026Medline 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
OFGNone listed
Apr 30, 2026Medline 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
OFGNone listed
Apr 17, 2026Medline 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
OFGNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Open, Classified
OFGNone listed
Apr 7, 2026Medline 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
OFGNone listed
Feb 17, 2026Medline 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
OFGNone listed
Jan 28, 2026Medline 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
OFGNone listed
Nov 14, 2025Medline 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
OFGNone listed
Apr 17, 2025MEDLINE 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
OFGNone listed
Mar 25, 2025MEDLINE 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
OFGNone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
Open, Classified
OFGNone listed
Dec 20, 2024MEDLINE INDUSTRIES, LP - Northfield
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Open, Classified
OFGNone listed
Dec 5, 2024MEDLINE 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
OFGNone listed
Oct 23, 2024MEDLINE 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
OFGNone listed
Sep 6, 2024MEDLINE 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
OFGNone listed
Aug 28, 2024MEDLINE 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
OFGNone listed
Aug 27, 2024MEDLINE 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
OFGNone listed
Feb 25, 2024MEDLINE 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
OFGNone listed
Aug 3, 2023MEDLINE 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
OFGNone listed
Jul 20, 2023MEDLINE 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
OFGNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Open, Classified
OFGNone listed
Feb 6, 2023MEDLINE 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
OFGNone listed

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