11 results
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17ms
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Sources: EU EUDAMED, US FDA
AEROSOL MASKS/ADULT & PAEDIATRIC
FDA 510(k)
FDA Class 1
·Anesthesiology
AVANZA
FDA 510(k)
FDA Class 2
·Radiology
Hospira Administration Sets
FDA 510(k)
FDA Class 2
·General Hospital
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·January 6, 2022
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COCR MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·August 2, 2017
EPOLY RINGLOC
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·August 2, 2017
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
PFC SIG RPF INS SZ 4 10MM
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code NJL·December 6, 2012
STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code LJH·June 22, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012