13 results
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19ms
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Sources: EU EUDAMED, US FDA
CALCIUM PLUS PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022476·PEERLESS 0DEG SGL FM 0TRQX018 LL/UR
LEONE SPA
FDA UDI
LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189398·AK3 Femoral Distal Locating Device, 2° Bushing
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 11, 2021
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 11, 2021
GIALLOY CB/N-H
FDA UDI
SRL Dental GmbH·ESRL58903021·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit
FDA 510(k)
FDA Class 2
·Microbiology
PRESSURE MONITOR, MODEL 212
FDA 510(k)
FDA Class 1
·Orthopedic
RIATA PASSIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 22, 2010
ULTIPAQ - PLATINUM MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·December 29, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024