17 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
FDA 510(k)
FDA Class 2
·Radiology
SR PIP
FDA UDI
Stryker GmbH·00886385020068·PIP PROXIMAL IMPACTOR ASSEMBLY
GOLDEN GATE ANTERIOR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
FDA 510(k)
FDA Class 1
·Dental
SIMPLEX P-JAPANESE TWIN PACK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·June 14, 2013
ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 18, 2011
SENSOR UROLOGICAL GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EZB·September 17, 2008
LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·July 15, 2024
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
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
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 24, 2023
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