10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LW Implant System
FDA 510(k)
FDA Class 2
·Dental
Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357239245·
MCNEIL HEALTHCARE LLC
FDA registration
MCNEIL HEALTHCARE LLC·3 products·🇺🇸 United States
AUTOCON II 200 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
TENDRIL DX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
VERSYS HIP SYSTEM FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LWJ·August 18, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 3, 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