11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ChoiceSpine TigerShark M, Modular Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Lysine Iron Agar Slants
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902209530·BD BBL™ Lysine Iron Agar Slants, Carton of 100 ...
NuVasive® Cohere® Thoracolumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
QT SCANNER 2000 MODEL A
FDA Adverse Event
Injury
·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·November 3, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 23, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 11, 2013
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018