20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LIQUID BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
SMS GLUCOSE CONTROL, MODEL 2120059
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197411318·Joseph Dissecting Scissor
curved...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970379·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970010·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970027·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970799·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974018·UniTip High Resolution Catheter 10F
MFCD 118I
FDA 510(k)
FDA Class 2
·Radiology
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2026
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT·Product code LWS·May 9, 2013
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·September 25, 2014
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JDI·June 7, 2011
IMPACTOR-FEM STEM-OFFSET
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 7, 2016
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025