65 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
ArgenZ HT+ 98x14 OM2
FDA UDI
ARGEN CORPORATION, THE·D818122027·Dental porcelain/ceramic restoration kit
CALIBRATING MATERIAL, BUFFERS, STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EASYTOUCH
FDA Adverse Event
Malfunction
·MHC MEDICAL PRODUCTS, LLC·Product code FMI·February 27, 2023
VENAPAX XL
FDA Adverse Event
Injury
·SAPHENA MEDICAL·Product code GEI·February 4, 2026
STERLING® SL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 4, 2026
EPIX® UNIVERSAL CLIP APPLIER
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code FZP·July 31, 2025
BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·June 30, 2023
HYLAN G-F20 48MG/6ML INJ, SYRINGE, 6ML
FDA Adverse Event
Injury
·SANOFI / GENZYME CORPORATION·Product code MOZ·June 12, 2025
HYLAN G-F20 48MG/6ML INJ, SYRINGE, 6ML
FDA Adverse Event
Injury
·SANOFI / GENZYME CORPORATION·Product code MOZ·June 12, 2025
ZOLL
FDA Adverse Event
Injury
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 9, 2025
HYLAN G-F20 48MG/6ML INJ,SYRINGE,6ML
FDA Adverse Event
Injury
·SANOFI / GENZYME CORPORATION·Product code MOZ·June 12, 2025
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD.·Product code HQL·May 16, 2013
CIC PRO CLINICAL INFORMATION CENTER
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code DSI·May 24, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 14, 2008
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 19, 2023
BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code EZL·March 24, 2026
LIQUID OPTICS INTERFACE
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code OOE·October 20, 2025