11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
ZESPIN SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Universal Ryno Lacer Wrist and Thumb Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235216·
LCP
FDA UDI
Synthes GmbH·10886982157836·3.5MM LCP PLATE 2 HOLES 33MM
EASY LIFE
FDA 510(k)
FDA Class 2
·Physical Medicine
RELIANCE SPINAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERADIUS
FDA Adverse Event
Injury
·PHILIPS HEALTHCARE·Product code OWB·October 29, 2014
GAMBRO CARTRIDGE BLOOD SET
FDA Adverse Event
Malfunction
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code KOC·July 15, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·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