8 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WALLACH INTEGRATION UNIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295246367·SIGMA TC3 RP INSERT TRIAL SIZE 3 30mm
TOP FINE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR.·Product code HQC·May 21, 2014
FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·December 17, 2010
CONSERVE(R) TOTAL A-CLASS HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·February 15, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024