25 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)
FDA Enforcement
Class II
·Terminated·Reckitt Benckiser LLC·March 1, 2017
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
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
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
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
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
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
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
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·December 7, 2016
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 15, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017