12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I-STAT LACTATE TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776306120·Jacobson Mosquito Forceps, extra delicate, 7", ...
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982071·posteriors; shade B4; size S; lower jaw
Multi-Sideport Catheter Infusion Set
FDA 510(k)
FDA Class 2
·Cardiovascular
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
FDA 510(k)
FDA Class 2
·Dental
PARADYM
FDA Adverse Event
Malfunction
·SORIN CRM S.R.L.·Product code NIK·February 8, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LGD·February 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 27, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 11, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 19, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024