41 results · 19ms · Sources: EU EUDAMED, US FDA

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STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496033837·PERSONALITY 140 SHEER, SIZE 4XXL, GLACE, GRADUA...

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033837·Baltic Denture System BDLoad BDLoad ↓ Lm6 PLSEu...

BIO-RAD PLATELIA TOXO IGM TMB

FDA 510(k)
FDA Class 2 ·Microbiology

FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

AGILE ESOPHAGEAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·April 3, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·March 17, 2011

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·April 25, 2008

Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025