12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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