14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
FDA 510(k)
FDA Class 2
·Dental
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017996·K-Wire, Single Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...
Avex CX
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205108142·Avex CX .018 LR5 (-17°T 2°A)
NA
FDA UDI
Synthes GmbH·10886982153593·4.5MM CORTEX SCREW 54MM
N/A
FDA UDI
Smith & Nephew, Inc.·00817470009552·FEMORAL LOCATOR 8MM
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586023545·
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
FDA 510(k)
FDA Class 2
·Cardiovascular
Cios Spin
FDA 510(k)
FDA Class 2
·Radiology
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 24, 2008
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSD·August 2, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 9, 2013
UROSKOP Omnia Max. Model Number: 10762473
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019