19 results · 35ms · Sources: EU EUDAMED, US FDA

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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