14 results · 23ms · Sources: EU EUDAMED, US FDA

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Z-Span Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A162824150·16mm H x 28mm W x 24mm L x 15 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A16282480·16mm H x 28mm W x 24mm L x 8 Degree ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A162824120·16mm H x 28mm W x 24mm L x 12 degrees ALIF

AOS UNIVERSAL CONECTING GUIDE TUBE

FDA 510(k)
FDA Class 2 ·Radiology

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC

FDA 510(k)
FDA Class 2 ·Anesthesiology

PENUMA IMPLANT

FDA Adverse Event
Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

DLT TS CER HD 12/14 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·February 28, 2019

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

HEARTMATE XVE LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·September 16, 2008

DLT TS CER HD 12/14 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LZO·June 29, 2017

SKINTACT

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code GEI·January 25, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022