15 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 22, 2023
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
FDA Enforcement
Class II
·Ongoing·Mc3 Inc·March 27, 2024
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
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