8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
FDA 510(k)
FDA Class 2
·Immunology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867047891·LO-PRO SCRW,SS 4.0X 40MMCANCLUS
MINATURE PRESSURE TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB
FDA 510(k)
FDA Class 1
·Anesthesiology
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·October 13, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 21, 2012
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