11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OIC Intramedullary Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Universal Ryno Lacers II Long
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357237616·
M/DN®
FDA UDI
Zimmer, Inc.·00889024039872·
VITA ENAMIC STAINS
FDA 510(k)
FDA Class 2
·Dental
PLATELETWORKS, MODELS PW-A, PW-C
FDA 510(k)
FDA Class 2
·Hematology
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR
FDA Adverse Event
Injury
·COOK, INC.·Product code FFL·October 30, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·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
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026