7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bonelogic
FDA 510(k)
FDA Class 2
·Radiology
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
FDA 510(k)
FDA Class 1
·General Hospital
HI-TORQUE WHISPER ES GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·August 25, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 10, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018