14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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