11 results
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18ms
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Sources: EU EUDAMED, US FDA
FreeStyle Libre 2 System, FreeStyle Libre 3 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDER NAIL
FDA UDI
Smith & Nephew, Inc.·03596010104496·3.5MM DIAMETER NAIL 3.5MMX37CM
...
POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
FDA 510(k)
FDA Class 1
·General Hospital
ALARIS PCA MODULE SETS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·June 5, 2017
SERI SURGICAL SCAFFOLD (US)
FDA Adverse Event
Injury
·ALLERGAN·Product code OXF·October 29, 2014
MAXISKY 600
FDA Adverse Event
Malfunction
·BHM MEDICAL INC.·Product code FNG·July 22, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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