10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MagVita TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
JASMINE PATIENT LIFT 9153649421
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIPMENT CO.·Product code FSA·April 23, 2015
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
FDA 510(k)
FDA Class 2
·Dental
HEALIX ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 17, 2008
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 8, 2025
HAART 200 AORTIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·CORCYM INC.·Product code KRH·May 9, 2025
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021