14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TalWire
FDA 510(k)
FDA Class 2
·Cardiovascular
Ryno Lacer Wrist and Thumb Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357237913·
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
Stainless Turbine
FDA 510(k)
FDA Class 1
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
HUMAPEN MEMOIR
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code NSC·August 26, 2011
DUROM ACETABULAR COMPONENT 52/46 CODE L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·July 10, 2013
RESTYLANE KYSSE
FDA Adverse Event
Injury
·Q-MED AB·Product code LMH·February 24, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·March 25, 2025
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