11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
FDA 510(k)
FDA Class 2
·Orthopedic
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356504·
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
SONICWAVE SONIC PLAQUE REMOVER
FDA 510(k)
FDA Class 1
·Dental
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 12, 2025
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Malfunction
·OPTONOL, LTD·Product code KYF·March 5, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 30, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
PKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
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