11 results
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37ms
·
Sources: EU EUDAMED, US FDA
ELECTRICAL VIBRATING DEVICE
FDA 510(k)
FDA Class 1
·Physical Medicine
CENTRIFICHEM HDL CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
PCA PLUS 2 NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·April 16, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 25, 2012
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·August 9, 2007
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024