11 results
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26ms
·
Sources: EU EUDAMED, US FDA
ACTIV Cap
FDA 510(k)
FDA Class 2
·General Hospital
TFCC Wrist Wrap
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357239146·
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981038359·39x30mm Trial 14mm 15 deg. The Vu a-POD interve...
RESTORELLE Y CONTOUR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COAXIA FLOCONTROL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 13, 2022
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 26, 2011
THREADED LOCKING DRIVER
FDA Adverse Event
Malfunction
·ALTUS SPINE·Product code HXX·July 3, 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