139 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Brilliance iCT; Product Code (REF): 728306;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·February 18, 2026
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Alinity ci-series System Control Module, REF: 03R70-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 3, 2024
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 17, 2024
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·September 22, 2021
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.·November 15, 2023
VERIQUICK PREGNANCY TEST 1CT, SKU 901260
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 900260
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·November 15, 2023
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
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
Plum Duo Precision IV Pump, 40002-0403
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026