17 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Traumatic brain injury (TBI) test
FDA 510(k)
FDA Class 2
·Immunology
ASO Speed Lacer Ankle Stabilizer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357236022·
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551077719·Micro Mirror, diameter 5 mm, 16 cm
CASCADIA™ Interbody System
FDA UDI
VB Spine LLC·10888857312609·AN Lordotic - Oblique Inserter 10 mm
TM ARDIS INTERBODY SYSTEM INSERTER
FDA 510(k)
FDA Class 2
·Orthopedic
SMALL VOLUME NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857235458·Hook Trial Size 6 mm
REXEED SERIES DIALYZERS
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·October 30, 2014
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·August 25, 2011
MONOCRYL PLUS SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 12, 2013
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 26, 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