12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA LITE RF IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983084·posteriors; shade C2; size M; upper jaw
Fuji Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
CT BRAIN PERFUSION FOR ZIOSTATION
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Zimmer, Inc.·00889024218796·
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 28, 2013
MAQUET CARDIOPULMONARY AG
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY AG·Product code KFM·July 1, 2014
ARTICULEZE M 28MM 1.5
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code LPH·February 4, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024