12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984070·anteriors; shade A2; mould O 85
Vermed
FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·00009336001262·Electrocardiographic recording paper
COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A
FDA 510(k)
FDA Class 2
·Radiology
B-D PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
ARCHITECT CREATINE KINASE
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 28, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·January 14, 2011
5MM EXTRA COARSE DIAMOND BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 18, 2013