13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
FDA 510(k)
FDA Class 1
·General Hospital
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 3, 2013
PARADIGM QUICKSERTER
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·November 4, 2014
ACCU-CHEK ® AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·August 25, 2011
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 12, 2013
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 14, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 14, 2023
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 14, 2023
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 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