12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
artegral life
FDA UDI
Merz Dental GmbH·D7091993096·anteriors; shade A3; mould UBIL
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471130500·K-WIRE - DOUBLE TROCAR WITH GUIDE 0.9mm DIA x 1...
S.I.N. Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
RACK-IT (R)
FDA 510(k)
FDA Class 2
·General Hospital
Proteus XR/a (SlOK : K993090)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KPR·August 9, 2019
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 7, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 8, 2011
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·August 8, 2014
Proteus XR/a (SlOK : K993090)
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·October 2, 2019
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK INC·Product code MIH·June 29, 2023
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026