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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