20 results
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19ms
·
Sources: EU EUDAMED, US FDA
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
FDA 510(k)
FDA Class 2
·Anesthesiology
BD BBL™ Sabouraud Liquid Broth, Modified (Antibiotic Medium 13)
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902210147·BD BBL™ Sabouraud Liquid Broth, Modified (Antib...
NA
FDA UDI
DEPUY MITEK, LLC·10886705007448·Spiked Washer 14mm
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033539873·
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193115115·HA PEEK EVOS Straight, ,14mmx8mmx 26mm , BICONV...
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690115403·Retaining Bolt PS or PS-C Insert, Modular Tibia...
TLS 5.0
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CX2210140·Interbody Fusion Device 7DEG x 22L x 10W x 14H
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221014070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221014000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221014150·
SOLAR GI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MyOnyx System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 3, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 4, 2013
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·November 3, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
MAXI MOVE
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·July 5, 2013
IMP,TSV,4.1MM,SBM,8
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·November 23, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·November 3, 2022
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025