17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Cysto-Gastro-Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRA-THIN SDS BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
FDA 510(k)
FDA Class 2
·Microbiology
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 1, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 27, 2007
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 6, 2024
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQY·December 28, 2006
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 21, 2023
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 5, 2007
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 28, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code DQY·April 12, 2007
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·October 20, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·August 10, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 8, 2013
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023