11 results · 21ms · Sources: EU EUDAMED, 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