17 results · 21ms · Sources: EU EUDAMED, US FDA

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AccelFix Lumbar Interbody Fusion Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319741832·Spratt (Brun) Bone Curette 6-1/2" (16.3cm), siz...

PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

FDA 510(k)
FDA Class 2 ·Orthopedic

EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...

FDA 510(k)
FDA Class 2 ·Orthopedic

RADIFOCUS OPTITORQUE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

INNOVA 2100

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS SCS·Product code MQB·October 6, 2008

PACS SERVER

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code LLZ·June 24, 2013

BOSTON SCIENTIFIC

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code KNT·July 29, 2011

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 8, 2019

GALAXY G3 XSFT 4MM X 8CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·April 14, 2022

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 6, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 26, 2021

SKINTACT

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code DRX·December 11, 2019

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

FDA Enforcement
Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022