15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HylaGuard Moisturizing Cream
FDA 510(k)
FDA Unclassified
·Unknown
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
FDA 510(k)
FDA Class 2
·Microbiology
ZIMMER DTO IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
MIO ADVANCE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FPA·July 20, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 7, 2013
STEPSIDER ADULT WALKER
FDA Adverse Event
Injury
·PROFIT COUNTRY ENTERPRISES·Product code ITJ·March 10, 2007
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·Product code DQX·May 21, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·December 28, 2021
CUSTOM PACK CB1Q91R6 NTUH CCS
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code DWE·June 22, 2022
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 17, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 3, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·October 31, 2023
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013
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