12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Compremium Compartment Compressibility Monitoring System (CPM#1)
FDA 510(k)
FDA Unclassified
·Unknown
NA
FDA UDI
Synthes GmbH·10886982157713·3.5MM MEDIAL DISTAL TIBIA PLATE 8 HOLES/121MM-LEFT
PROFYLE
FDA UDI
Stryker GmbH·07613153160601·Tension Sheath
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 4, 2024
MARISA
FDA Adverse Event
Malfunction
·ARJO MED AB LTD.·Product code FSA·July 13, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 12, 2013
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