144 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Diagnostic Kit SARS-cCo V Antigen Rapid Test
FDA Enforcement
Class II
·Ongoing·USA Medical, LLC·May 18, 2022
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·July 12, 2023
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·July 12, 2023
Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 22, 2023
Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 22, 2023
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 22, 2024
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 22, 2024