14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EcoFit Vit E Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181583·Integra® Jarit® Grooved Director - Tongue Tie, ...
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·December 7, 2020
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 16, 2022
FLOSEAL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - HAYWARD·Product code LMF·August 23, 2018
COUPLER
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SAINT PAUL - MCA·Product code MVR·February 8, 2019
COUPLER
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SAINT PAUL - MCA·Product code MVR·February 8, 2019
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code MND·June 13, 2013
PHYSIO-CONTROL LIFEPAK 20
FDA Adverse Event
Malfunction
·MEDTRONIC INC. (MEDTRONIC EMERGENCY RESPONSE SYSTEMS)·Product code LDD·September 19, 2008
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·February 21, 2019
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024