17 results
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20ms
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Sources: EU EUDAMED, US FDA
WAKO AUTOKIT C3
FDA 510(k)
FDA Class 2
·Immunology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150098·Endo Carry-on Procedure Kit Includes Intercept ...
Oxygen Sensor
FDA UDI
MERCURY ENTERPRISES, INC.·10641043103265·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450125892·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0100260·Tray Insert, Lumbar Screw Rack 10 x 10
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100260·Assembly, Caddie, Implants, Hinged
AMBICOR PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·December 6, 1996
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 18, 2025
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
FDA 510(k)
FDA Class 1
·Ophthalmic
EMBOGOLD MICROSPHERE
FDA 510(k)
FDA Class 2
·Neurology
TRUSTEEL
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 19, 2025
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC.·Product code MND·March 13, 2013
SN60WF INTRAOCULAR LENS
FDA Adverse Event
ALCON LABORATORIES·Product code HQL·February 24, 2011
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCW·December 30, 2019
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013