14 results · 22ms · Sources: EU EUDAMED, US FDA

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Laser Ureteral Catheter

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEG LAPAROSCOPIC ELECTRODES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS

FDA 510(k)
FDA Class 2 ·Cardiovascular

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 14, 2013

TRAY, FOLEY, URINE METER, BARDEX I.C. COMPLETE CARE, INFECTI

FDA Adverse Event
Malfunction ·BARD·Product code KOD·July 15, 2011

HAART 200 AORTIC ANNULOPLASTY RING

FDA Adverse Event
Injury ·CORCYM INC.·Product code KRH·May 8, 2025

HAART 200 AORTIC ANNULOPLASTY RING

FDA Adverse Event
Injury ·CORCYM INC.·Product code KRH·May 9, 2025

SPYSCOPE DS II ACCESS & DELIVERY CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

SPYSCOPE DS II ACCESS & DELIVERY CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

BARD FLAT MESH

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·July 7, 2023

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019