13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENZYMUN TEST TBG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
K2-HF DENTINE, D-B4, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38621090·
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177416·Modular Trial, 14 x 13 x 9mm, 10 Deg Lordosis
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862109180·Standard Band, Tooth 45/35, Size 9/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862109220·Standard Band, Tooth 45/35, Size 9/Roth 22
Kwart Retro-Inject Ureteral Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BINAXNOW INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
COBAS INTEGRA 400 PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2025
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·June 10, 2014
SWEET PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·November 29, 2012
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·January 16, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012