19 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
VIDAS TOXO IGG AVIDITY
FDA 510(k)
FDA Class 2
·Microbiology
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 21, 2013
PROXIMATE** SKIN STAPLER 35 WIDE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDT·July 28, 2011
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·September 26, 2008
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·January 15, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2019
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
VERITAS VISION SYSTEM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·January 8, 2026
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021