11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD SmartSite Needle-Free Connector
FDA 510(k)
FDA Class 2
·General Hospital
Infinity Acute Care System (IACS) Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
BONE GRAFT SYRINGE, MODEL 8600-00X0
FDA 510(k)
FDA Class 2
·General Hospital
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 25, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 4, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013
PU-681RA
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·November 22, 2024
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
FDA Enforcement
Class II
·Ongoing·Labories Medical Technologies·May 10, 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