10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO OMEGA 21 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
FDA 510(k)
FDA Class 2
·Ophthalmic
CONSERVE(R) TOTAL A-CLASS(R) FEMORAL HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·April 10, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 2, 2014
WAVELIGHT EX500 EXCIMER LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·April 7, 2011
AXIUM 3D
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·March 29, 2023
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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