12 results · 23ms · Sources: EU EUDAMED, US FDA

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ROCHE COBAS MIRA PLUS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RECTANGLE 25IN BLUE VINYL

FDA UDI
ALIMED, INC.·00733657237153·

Instrument Case

FDA UDI
KATENA PRODUCTS, INC.·00841668110997·DOUBLE PLASTIC STERILIZATION CASE

Arthrex®

FDA UDI
ARTHREX, INC.·00888867058750·UNIVERS FRACTURE STEM EXTRACTION ADAPTER

VirtuOst

FDA 510(k)
FDA Class 2 ·Radiology

CRUX VENA CAVA FILTER SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·January 17, 2013

COLLEAGUE CXE VOLUMETRICINFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 10, 2010

REGENCY

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

EasyPoint Needle, 25G x 5/8", REF: 82091

FDA Enforcement
Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

Product Name: Alcon Custom Pak Model/Catalog Number: Many 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·August 28, 2024

Alcon Custom Pak

FDA Enforcement
Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023