539 results
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14ms
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Sources: EU EUDAMED, US FDA
Diagnostic Kit SARS-cCo V Antigen Rapid Test
FDA Recall
Open, Classified
·USA Medical, LLC·Product code QKP·April 4, 2022
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DYG·February 14, 2023
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DYG·February 14, 2023
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·February 21, 2025
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CEO·September 3, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code CEO·April 24, 2025
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
SmartPath to dStream for 3.0T Model Number (REF): 782145
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Ingenia 1.5T S Model Number (REF): 781347
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Achieva 3.0T TX for PET Model Number (REF): 781479
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024