9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECGenius System
FDA 510(k)
FDA Class 2
·Cardiovascular
GREENCROSS SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
INCLUSIVE TAPERED IMPLANT 4.2 MMD X 11.5 MML X 3.5 MMP
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 25, 2026
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
REGENEREX AUGMENT 52MM SM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MEH·July 12, 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
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026