13 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

INTUITION - TDA, TVA, PARAMETRIC MAPPING

FDA 510(k)
FDA Class 2 ·Radiology

ArgenIS

FDA UDI
ARGEN CORPORATION, THE·D818131447·MUA NC NP 1.5GH Str

CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G

FDA 510(k)
FDA Class 2 ·Radiology

ZIMMER PERIARTICULAR SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code DTB·October 1, 2014

URETEX SUPPORT PP TRANSOBTUR2 KIT X1

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·May 10, 2013

ASKU

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015