7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOSCOPY(TM) BRAND, ENDOBAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·January 14, 2013
ANGIO-SEAL DEVICE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·November 24, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015