10 results
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18ms
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Sources: EU EUDAMED, US FDA
FLUOROMETER, GENERAL USE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435062469·MCD Screw 3.0 x 24 mm M2
non lo...
CONI
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON MANUFACTURING, LTD./ HUNTINGTON·Product code HQL·May 5, 2014
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·November 13, 2012
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025