14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Vittra APS Unique Flow
FDA 510(k)
FDA Class 2
·Dental
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G586G2329940·microsurgery needle holder, round handles, 7" (...
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
FDA 510(k)
FDA Class 2
·Neurology
IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·July 28, 2022
COBAS 8000 E 602 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 19, 2017
COBAS 8000 E 602 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 10, 2018
ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 22, 2018
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 6, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 20, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 18, 2013
COBAS 6000 E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 17, 2018
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
FDA Enforcement
Class II
·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025