11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ceramill Zolid HT+ white
FDA 510(k)
FDA Class 2
·Dental
CROSS.BONE
FDA 510(k)
FDA Class 2
·Orthopedic
DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
FDA 510(k)
FDA Class 2
·Cardiovascular
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 28, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·February 27, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 1, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NDN·February 27, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JIT·June 17, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 22, 2011
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021