15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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014 Hydrophilic Coated PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
LuxaPrint Ortho Flex 385
FDA UDI
DMG Digital Enterprises SE·D9821712510·(Meth) acrylate-based light-curing resin for th...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293180·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049484·K-Wires, Single diamond, round end, .035-inch (...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012863·K-Wires, Single diamond, round end, .035-inch (...
DEMI
FDA 510(k)
FDA Class 2
·Dental
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
FDA 510(k)
FDA Class 2
·Immunology
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·January 8, 2015
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·June 14, 2013
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code LXH·September 19, 2008
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 30, 2025
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·December 22, 2023
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·December 22, 2023
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018