13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XT Stain/Glaze
FDA 510(k)
FDA Class 2
·Dental
STRYKER BIOZIP SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
NaviCam Xpress Stomach System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·August 16, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
OT ULTRA MINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·December 2, 2020
OT ULTRA MINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE GMBH·Product code NBW·December 2, 2020
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 5, 2010
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025