10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Localite TMS Navigator TS
FDA 510(k)
FDA Class 2
·Neurology
SYNGO.VIA MI WORKFLOWS
FDA 510(k)
FDA Class 2
·Radiology
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
FDA 510(k)
FDA Class 1
·General Hospital
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·August 5, 2014
LOCKSCR Ø3.5 SELF-TAP L30 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·July 12, 2013
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 18, 2024
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 18, 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