10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diode Laser Hair Removal System (RD-SLD600)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pressure Sentinel® Intramedullary Reaming System
FDA UDI
Zimmer, Inc.·00889024039971·
DRESSSKIN
FDA 510(k)
FDA Unclassified
·Unknown
IV Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
DIMENSION VISTA 1500
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·November 4, 2014
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 25, 2011
M2A MAGNUM MODULAR HD COCR 44MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·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