17 results · 24ms · Sources: EU EUDAMED, US FDA

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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