9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
CHAD LABS ADHESIVE BANDAGE REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·January 29, 2019
MEDLINE REUSABLE SURGICAL GOWNS (100X)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTRONIC PULSE MASSAGER
FDA 510(k)
FDA Class 2
·Neurology
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·January 30, 2019
PRIME ZOOM STRETCHER,30"LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·January 28, 2013
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·November 30, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2014
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