18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Digital Blood Pressure Monitor-Wrist Style
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294217·
MOSAIC DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 23, 2013
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·July 15, 2024
CONQUEST PRO 12 ST
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·June 29, 2020
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 14, 2024
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·August 19, 2021
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·May 15, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 14, 2023
ASTATO XS 9-12
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 7, 2023
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·January 27, 2022
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