11 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
FDA 510(k)
FDA Class 2
·Medical Genetics
GLOBAL CAP CTA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105633·GLOBAL C.A.P. CTA CTA THREADED PIN 6 IN
TRUECPR COACHING DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
ASAHI REXEED SX/LX DIALYZERS
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD·Product code KDI·October 30, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 25, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 12, 2013
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026
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