15 results · 27ms · Sources: EU EUDAMED, 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