14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
QUICK VUE INFLUENZA
FDA 510(k)
FDA Class 1
·Microbiology
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799007155·
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131599·MUA ZS RP 2.5GH Ang17
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660198906·Irrigating cystotome, 23 gauge x 5/8'', vaulted...
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657016469·Anvil Grasper, 10mm, reinforced version insert ...
RVT CTO DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
CD LEYCOM PRESSURE/VOLUME CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 28, 2019
DXTEND SCREW LOCK D4.5X30MM
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code HSD·October 1, 2014
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011
OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·May 17, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·January 31, 2018
40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019