17 results · 29ms · Sources: EU EUDAMED, US FDA

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Cios Select (VA21) Flat Panel

FDA 510(k)
FDA Class 2 ·Radiology

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154156208·BONE SCREWS,CROSS-PIN,SELF-TAPPING

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·37613327419277·BONE SCREWS, CROSS-PIN, CUTTING FLUTE

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540355790·Bone Screws, Cross-Pin

HEALTHY SLEEP APPLIANCE

FDA 510(k)
FDA Class 2 ·Dental

VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 25, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014

PELVISOFT ACELLULAR COLLAGEN BIOMESH

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·July 9, 2013

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

OSS TIBIAL POLY BEARING 18MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 2, 2016

BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·July 8, 2019

FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·October 3, 2019

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024