539 results · 13ms · Sources: EU EUDAMED, US FDA

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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