10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOCOR HPH 700 HEMOCONCENTRATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983085·posteriors; shade C2; size M; lower jaw
Sklar®
FDA UDI
SKLAR CORPORATION·10649111153723·JACOBS NH SPR HDL STR 8 1/2
CoreDx Pulmonary Mini-Forceps
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·February 28, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
PINN LNR CON +4 NEUT 28IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWZ·February 4, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
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