15 results
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7ms
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Sources: EU EUDAMED, US FDA
FIRST RESPONSE 2 CT, SKU 902343
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
VERIQUICK PREGNANCY TEST 1CT, SKU 901260
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
FIRST RESPONSE 2 CT, SKU 902343
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Veriquick Pregnancy Test 2CT, SKU 903756
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
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
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1159B; 6) SUTURE TRAY, Pack Number DYNDS1064B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
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 SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 25, 2026
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 SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026