11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DRYSPOT E.COLI 0157 KIT
FDA 510(k)
FDA Class 1
·Microbiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993401·anteriors; shade C4; mould BM
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code HET·June 8, 2006
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
FDA 510(k)
FDA Class 2
·Dental
SPECIAL RONGEUR
FDA 510(k)
FDA Class 2
·Neurology
COOK SPECTRUM
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·December 27, 2018
COOK SPECTRUM
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·December 20, 2018
STERLING¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·March 7, 2013
THERA-I DR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code DXY·August 8, 2014
PARADIGM REAL-TIME REVEL INSULIN INUFUSION PUMP MMT-523PNAL
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·January 21, 2011
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·July 16, 2025