13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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The GIRO Growth Modulation System
FDA 510(k)
FDA Class 2
·Orthopedic
DeBakey Carotis Clamp 1.5cm angled 18cm
FDA UDI
Geister Medizintechnik GmbH·04057034053256·DeBakey Carotis Clamp 1.5cm angled 18cm
PORTADUR P 4
FDA 510(k)
FDA Class 2
·Dental
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·April 20, 2005
FREESTYLE LIBRE 2
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QLG·May 9, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 23, 2011
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 17, 2014
TRIAGE CARDIAC PANEL TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code NBC·February 24, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025