46 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
LACE UP
FDA UDI
RIVERPOINT MEDICAL, LLC·00812444026177·SUTURE
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958001741·400 Micron Disposable Diode Laser Lightguide, 0...
FAC-4 - Duke Power Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041034·Plate Bending Forceps, Large
ABP-2000 G-3
FDA 510(k)
FDA Class 2
·Cardiovascular
GEIGER NEEDLE ADAPTER, MODEL 406
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2025
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE LTD·Product code FRN·October 20, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
NEEDLE 18GA 2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 13, 2021
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021
POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)
FDA Adverse Event
Injury
·SANOFIAVENTIS U.S. LLC·Product code LMH·April 2, 2010
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·December 17, 2010
BD PHASEAL OPTIMA INJECTOR (N40-O)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Enforcement
Class II
·Ongoing·PATH·December 6, 2023
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·October 25, 2010
GELFOAM
FDA Adverse Event
Malfunction
·PFIZER, INC. (DEVICE)·Product code LMF·May 6, 2019