13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERITON CT whole body SPECT/CT system
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...
Pre-Finisher
FDA UDI
TP ORTHODONTICS INC·00192029042212·4 Bicuspid Extraction
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961904570·Bowmann lachrymal probe, Silver,
cylind...
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·November 7, 2025
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 9, 2021
OPUS SPEEDSCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ORALUBE
FDA 510(k)
FDA Class 1
·General Hospital
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code FJI·June 21, 2013
EGIA ULTRA UNIVERSAL XL STAPLER
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·July 29, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024