15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
RxSight Insertion Device
FDA 510(k)
FDA Class 1
·Ophthalmic
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025
ACELL MATRISTEM WOUND SHEET
FDA 510(k)
FDA Unclassified
·Unknown
GEMORE MUSCLE CONDITIONER;
FDA 510(k)
FDA Class 2
·Physical Medicine
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025
HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·July 22, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·October 22, 2014
ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023
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
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
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016