10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DANEK PRECISION ROD SET
FDA 510(k)
FDA Class 2
·Orthopedic
UROLOGICAL STONE BASKET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUALA DENTAL PRODUCTS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·August 31, 2011
ACE
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAL·August 30, 2010
HU-FRIEDY PERMA SHARP SUTURES
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·June 2, 2010
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 16, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORP·Product code FRN·December 28, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020