14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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