9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
FDA 510(k)
FDA Class 2
·Cardiovascular
Med Spec Boxer Splint
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235742·
GIZMO
FDA 510(k)
FDA Class 1
·Physical Medicine
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
FDA 510(k)
FDA Class 2
·Neurology
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 4, 2014
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code EOQ·August 25, 2011
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
FDA Adverse Event
C. R. BARD INC. (BASD)·Product code LJS·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