7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAHO AUTOCLAVABLE LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHEMED DEVICE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
3.0MM TI CERVICAL SPINE LOCKING SCREWS
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code ODP·February 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024